Isocetyl Salicylate

The Basics On Isocetyl Salicylate

What is Isocetyl Salicylate?

What are other names for Isocetyl Salicylate?

ISOCETYL ESTER SALICYLIC ACID, ISOCETYL SALICYLATE, and SALICYLIC ACID, ISOCETYL ESTER

What is Isocetyl Salicylate used for?

isocetyl-salicylate TEA-Salicylate, is used as an ultraviolet light absorber to protect cosmetics and personal care products from deterioration by UV rays.

How Isocetyl Salicylate is classified

Miscellaneous

Recommendations for using Isocetyl Salicylate during pregnancy and breastfeeding

Limited data suggests no known risk

 

Isocetyl Salicylate During Pregnancy

What we know about using Isocetyl Salicylate while pregnant or breastfeeding

Limited information available.

In Vitro Salicylic Acid The effect of Salicylic Acid on human spermatozoa was determined after incubation with 50, 100, or 200 mg/l salicylate for 2 to 48 h. 1 A dose response effect was observed, with significant inhibition of motility at all time points. Post-implantation day 11 rat embryos were cultured for 24 h with 10, 100, or 1000 μg/mL Salicylic Acid. 50 The growth and development of each embryo was evaluated and compared with control embryos for the presence of any malformations. Salicylic Acid decreased all growth and developmental parameters in a concentration-dependent manner, when compared with controls. However, exposure to Salicylic Acid at 10 μg/mL culture did not show any significant effect on embryonic growth and development. Parallel to this, flow cytometric analysis (cell cycle and annexin V binding) and DNA fragmentation assay were carried out followed via quantitation by 3ʹ-OH labeling of cultured rat embryos to evaluate the role of apoptosis in bringing about Salicylic Acid-induced teratogenesis. All results were found to be dose-dependent and an increase in apoptosis in embryonic tissues may be related to the increased risk of congenital malformations. The data suggested that apoptosis might be involved in mediating teratogenesis of Salicylic Acid in vitro. Salicylic Acid and Sodium Salicylate The effects of Salicylic Acid and Sodium Salicylate on early organogenesis and the interaction of these chemicals with free radicals was investigated.51 Post-implantation Wistar rat embryos were cultured in vitro from day 9.5 of gestation for 48 h; each test substance was added to whole rat serum at concentrations between 0.1 and 0.6 mg/mL. Also, each test substance (0.3 mg/mL) was added to the culture media in the presence of superoxide dismutase (30 enzyme units (U)/mL) or glutathione (0.5 µmol/mL). The growth and development of embryos was compared, and each embryo was evaluated for the presence of malformations. When compared to the growth of control embryos, both chemicals decreased all growth and developmental parameters in a concentration-responsive manner. There was also a concentration-related increase in overall dysmorphology, including the following: hematoma in the yolk sac and neural system, open neural tube, abnormal tail torsion, and the absence of forelimb bud. When superoxide dismutase was added in the presence of Salicylic Acid, the incidence of malformations was decreased. However, the addition of superoxide dismutase did not affect the growth and developmental parameters of Salicylic Acid and Sodium Salicylate. The addition of glutathione significantly decreased the incidence of the malformations that were observed in the presence of Salicylic Acid. The authors noted that the effects of salicylates might involve free oxygen radicals by the non-enzymatic production of the highly teratogenic metabolites 2,3-dihydroxybenzoic acid and 2,5-dihydroxybenzoic acid. Furthermore, they noted that an enhanced production of these metabolites in embryonic tissues may be directly related to the increased risk of congenital malformations. Animal Dermal Methyl Salicylate Methyl Salicylate was applied (at 7 days 9 h of gestation) to dorsal skin of timed-pregnant LVG hamsters (number not stated), at doses of 350 and 525 mg/100 g.1 Few embryos from the high-dose group survived beyond 12 days of gestation, but, of the 19 litters produced in this group, there were 53% neural tube defects. Of the 6 litters produced in the lower dose group, 6% of the fetuses had neural tube defects. A peak salicylate level of 50 mg/100 mL was obtained 5 to 6 h after topical application of 350 mg/100 g and a peak of 120 mg/100 g with the 525 mg/100 g topical treatment level. Thus, dermal exposure to Methyl Salicylate is associated with reproductive and developmental toxicity as a function of blood levels reached as a result of exposure. Oral Ethylhexyl Salicylate Because the following 2 study summaries (from different sources) involve the same strain of rats and doses, and 1 maternal death in the highest dose group is reported in both, it is possible that results from the same study are being reported. However, because a NOAEL is being reported in one study summary, and a NOEL in the other, and the dose corresponding to each is not the same, the results are being presented separately. The developmental toxicity of an Ethylhexyl Salicylate trade name material was evaluated using groups of 11 RccHanTM: WIST(SPF) male and female rats.47 The test substance (in corn oil) was administered by gavage to 3 groups at doses of 25, 80, and 250 mg/kg/day, respectively. The exposure (once daily exposure) periods for males and females were 28 days and ~ 7 weeks, respectively. Males were treated over a 14-day pre-pairing period and during the pairing period up to 1 day before necropsy. Females were treated throughout the pre-pairing, pairing, gestation and lactation periods up to day 3 post-partum. Maternal toxic effects were described as slight, but non-significant, changes in weight gain at a dose of 250 mg/kg/day. Because of the reduced absolute body weights of pups from the 250 mg/kg/day dose group, the NOEL for developmental toxicity was considered to be 80 mg/kg/day. No test substance-related microscopic findings were observed in pups from any of the dose groups. Another interpretation of data from the same study appears below. In a developmental toxicity study that was performed according to the preceding test procedure (same doses, number of animals per group, and species), 1 maternal death (in highest dose group) that was unrelated to dosing with the same Ethylhexyl Salicylate trade name material was reported.30 There were no further reports of adverse effects in males or females that were mated. In the 80 and 250 mg/kg/day dose groups, a reduction in the gestation index as well as an increased incidence of post-implantation loss (i.e., reduced litter sizes) were observed. These findings were dose-related as well as statistically significant, and were deemed test substance-related. No test substance-related effects were observed during the first litter check or during lactation in any of the dose groups. Dosing with the test substance also had no effect on pup sex ratio. A test substance-related effect on pup body weight (reduction in absolute body weight) was observed in the highest dose group. There were no test substance related effects (on body weight or body weight gain) in the 2 lower dose groups. Furthermore, no test substance-related macroscopic findings in pups were observed in any of the dose groups. Based on observations of increased post-implantation loss, reduction in the gestation index, and lower litter size, the no-observedadverse-effect-level (NOAEL) for developmental toxicity was determined to be 25 mg/kg/day. Methyl Salicylate Methyl Salicylate was delivered by oral intubation (1.75 g/kg) to timed-pregnant LVG hamsters at 7 days 9 h of gestation.1 Blood levels reached a peak at of 125 mg/100 mL at approximately 2 h after oral dosing. Of 35 litters (number of fetuses per litter not given) in the treatment group, 72% of the fetuses had neural tube defects. Groups of 24 to 27 rats were fed 4000 ppm or 6000 ppm Methyl Salicylate in a test diet containing calcium carbonate for 60 days prior to mating and through weaning at day 20 or 21. This procedure was repeated. Abnormalities were not observed in offspring. Neonate survival at weaning was greater in the test group than in the control group. Groups of F0 generation mice (25/sex/group) and F1b generation mice (30 males and 30 females/group) received 0.25% or 0.5% Methyl Salicylate in feed for 30 days prior to mating. The results are only from females in each generation that mated twice. There was no evidence of gross abnormalities in any litter. All surviving neonates appeared normal, and no reproductive abnormalities were observed. Another experiment in the same study involved the same numbers of F0 and F1b animals (in this experiment, Wistar rats used) and the same concentrations of Methyl Salicylate administered in feed. The protocol was the same, except for the 60-day feeding period prior to mating. Gross abnormalities were not observed in any litter and all surviving neonates appeared normal. Mating performance and reproduction and viability indices were decreased, and the number of deaths between birth and day 5 were increased in the 0.5% group. Litter size was decreased in both test groups. Groups of F0 generation Osborne-Mendel rats (10/sex/group) received 500, 1500, 3000, or 5000 ppm Methyl Salicylate in feed for 100 days, after which the animals were mated. There was no evidence of gross abnormalities. Various reproductive effects were observed, especially in the 2nd generation. In a continuous breeding reproductive toxicity study, male and female CD-1 mice (number not stated) were dosed orally with 25, 50, or 100 mg/kg Methyl Salicylate. Reproductive and fertility parameters were generally not affected. There also was no significant effect on mating behavior, fertility rate, or reproductive performance. Groups of CD-1 mice (20/sex/group) were dosed orally with 100, 250, or 500 mg/kg Methyl Salicylate in another continuous breeding reproductive toxicity study. A significant decrease in the mean number of litters, average number of pups/litter, proportion of live pups, and mean live pup weights was observed in the high dose group. CD rats (number not stated) received an oral dose of Methyl Salicylate (0.05 mL or 0.1 mL) on gestation day 10. The 0.1 mL dose group had decreased body weight gain, fewer and smaller neonates, and more resorptions and malformed neonates. Fetal kidney weight was decreased on gestation day 21, but was not different from the control on postnatal day 6. Salicylic Acid Groups of 20 gravid Wistar rats were fed a diet containing 0.06%, 0.1%, 0.2%, or 0.4% Salicylic Acid on gestation days 8 to 14.1 Significant reproductive effects were observed in the 0.4% dietary group, and skeletal anomalies were observed in the 0.2% group. Only one dam gave birth to live neonates in the 0.4% dietary group, and skeletal anomalies were observed in 0.2% neonates. Groups of Wistar rats were dosed orally with Salicylic Acid at a dose of 75, 150, or 300 mg/kg on gestation days 8-14. Fetal mortality was 26% and 100% in the 150- and 300-mg/kg groups. Significant reproductive effects were observed in fetuses and neonates of the 150 mg/kg group. Groups of 10 Sprague-Dawley rats were dosed twice daily with 10 mg/kg Salicylic Acid on gestation days 20 and 21, and the mean gestation period was increased. Sodium Salicylate New Zealand White rabbits (number not stated) were dosed orally with 100 mg/kg Sodium Salicylate on gestation days 4 to 7.1 The preimplantation ratio and average litter size were not affected, and teratogenic effects were not induced. Two groups of 21 albino rats each received 200 mg/kg Sodium Salicylate orally on gestation days 6 to 15. A significant increase in resorptions and decrease in viable fetuses was observed in one group. A significant increase in external and internal abnormalities was observed in the second group, and skeletal anomalies were observed in both groups. Groups of 17 to 19 Sprague-Dawley rats received an oral dose of 30, 90, or 180 mg/kg Sodium Salicylate on gestation days 6 to 15. The incidence of teratogenicity was 30% in the 180 mg/kg group; marked embryotoxicity was observed and maternal toxicity was low. Regarding the 90- and 180-mg/kg groups, a dose-dependent decrease in growth was reported. SpragueDawley rats (number not stated) received oral doses of 1500 mg/kg and 300 mg/kg Sodium Salicylate, respectively, on gestation days 7, 8, 9, 10, or 11. Skeletal anomalies increased with dosing on days 8 and 10. Two groups of 2 CFE rats were dosed orally with 500 mg/kg Sodium Salicylate (on gestation day 8) or 100 mg/kg Sodium Salicylate (on gestation days 7 to 11). Results for the higher dose group included 50% maternal toxicity, 53% resorptions and dead fetuses, and 13% malformations. In the 100 mg/kg group, there was a 15% incidence of resorptions and dead fetuses. Groups of 12 to 15 albino rats received an oral dose of 25, 75, or 150 mg/kg Sodium Salicylate on gestation days15 to 20. Parturition was delayed in one and two dams of the 25 and 150 mg/kg groups. In the 150 mg/kg group, neonatal mortality increased in a dose-dependent manner. In another experiment, in the same study, groups of 12 to 15 albino rats received an oral dose of 4.2, 12.5, or 25 mg/kg Sodium Salicylate on gestation days 20 to 21. In the 12.5 and 25 mg/kg groups, neonatal mortality increased in a dose-dependent manner. Groups of 10 Sprague-Dawley rats received an oral dose of 10 mg/kg Sodium Salicylate twice daily on gestation days 20 and 21. The duration of bleeding at parturition was increased. Thirteen of 121 neonates were born dead. Sprague-Dawley and Long-Evans rats (number not stated) received an oral dose of 125 or 175 mg/kg Sodium Salicylate on gestation days 8 to 10. No malformations were observed. CD-1 mice (number not stated) received oral doses of 1500 mg/kg and 300 mg/kg Sodium Salicylate, respectively, on gestation days 7, 8, 9, 10, or 11. Fetal mortality increased with dosing on day 10. Skeletal anomalies increased with dosing on days 8 and 9. Groups of 19 or 37 CD-1 mice received doses of 2000 and 2600 mg/kg Sodium Salicylate on gestation day 8. Results for the 2000 mg/kg group were: 11% maternal mortality, 71% viable litters, 14% fetal mortality, and 7% of fetuses with malformations. Results for the 2600 mg/kg group were: 24% maternal mortality, 79% viable litters, 7% fetal mortality, and 3% of fetuses with malformations. Twenty-two CD-1 mice received an oral dose of 800 mg/kg Sodium Salicylate on gestation days 8 to12. The average neonatal weight was decreased on postnatal days 1 and 3. Thirty ICR/SIM mice received an oral dose of 1600 mg/kg on gestation days 8 to 12, and 7 dams died. Neonate survival and the average number of viable neonates per litter on days 1 and 3 were significantly decreased and the number of dead neonates per litter on day 1 was significantly increased. Twenty-five A/Jax mice received an oral dose of 66.6 mg/mL Sodium Salicylate on gestation day 17. One dam delivered between 5 Р24 h. Fetal mortality was 47%, and the incidence of superficial, hepatic, and gastric hemorrhage was 6%, 1%, and 2% in dams killed at 24 h.1 Groups of 15 mated Crl:CD (SD)BR rats were given a single dose of 0 or 300 mg/kg (dose volume = 10 mL/kg) Sodium Salicylate (99.5% pure, in distilled water) on gestation day (GD) 9. 52 All fetal data, including all supernumerary ribs data, are presented as the percentage mean per litter. No statistical analysis was carried out on mean incidences of supernumerary ribs and the number of presacral vertebrae. In the treated group, adverse effects were noted on body weight changes and food consumption during the 2 days following dosing. At birth, a high majority of pups had extra ribs at the 300 mg/kg dose. Specifically, on postnatal day 1, 89% of pups from dams exposed to 300 mg/kg Sodium Salicylate had supernumerary ribs. For these pups, evidence of postnatal reversibility was observed in 10 out of 14 pups with rudimentary ribs and 26 presacral vertebrae. Radiographs done on postnatal days 1, 6, 14, 28, and 54 showed a reduction in the incidence of rudimentary ribs only, whereas extra ribs, often associated with 27 presacral vertebrae, had the same incidence from birth to adult stage. Furthermore, extra ribs seemed to exhibit similar growth evolution to the other thoracic ribs. The authors noted that dosing with Sodium Salicylate resulted in a significant increase in the incidence of supernumerary ribs. The length of gestation was not affected by treatment. At birth, the number of dead pups was slightly higher in the treated group (7 dead pups out of 15 litters) in comparison with the control group (3 out of 14 litters) but no external malformations were significantly increased in the treated group. In a study involving mated female Sprague-Dawley rats, Sodium Salicylate was administered by gavage on GD 9 at a dose of 300 mg/kg (in distilled water).53 Control animals received distilled water only. The females were killed on GD 13. The mean number of live embryos was slightly lower than the control group value (11.9 as compared to 14.7), mainly due to a slight, but non-significant, increased number of early resorptions in the treated group. Because Sodium Salicylate is known to cause an increased incidence of supernumerary ribs (see preceding study), the molecular basis of this defect was evaluated in this study by analyzing the possible involvement of Hox genes, known to specify vertebrae identity. On GD 13, the expression of several Hox genes, selected according to the position of their anterior limit of expression, namely upstream (Hoxa9), at the level (Hoxa10) and downstream (Hoxd9) to the morphological alteration, were analyzed. Posterior shifts in the anterior limit of expression of Hoxa10 and Hoxd9 were observed following exposure to Sodium Salicylate, which could explain an effect at the level of the axial skeleton. This finding suggests that the appearance of ectopic ribs can be attributed to an anterior transformation of lumbar vertebrae identity into thoracic vertebrae identity. The authors noted that whether this transformation occurs with all compounds inducing supernumerary ribs in rats remains to be determined. Sodium Salicylate served as the positive control in an embryo-fetal developmental toxicity study.54 The positive control (in distilled water) was administered intragastrically (dose = 250 mg/kg/day; once daily) to a group of 22 to 24 gravid female Sprague-Dawley rats on GDs 8 to 10. Sodium Salicylate was administered at a dose volume of 10 mL/kg/day. There were 4.8% malformations in fetuses from the positive control group, including exencephaly, cranial meningocele, spina bifida, gastroschisis, and subcutaneous ecchymosis. The rate of abnormality was significantly higher than that of the vehicle control group (p < 0.01). Additionally, there were significant decreases in the body and tail length, and mean body weight of fetuses in the positive control group when compared with the vehicle control group (p < 0.01). Human Dermal Salicylic Acid In the third trimester, the use of Salicylic Acid can potentially cause early closure of ductus arteriosus and oligohydramnios. Therefore, it should not be applied over large surface areas for prolonged time periods, or under occlusive dressings that may enhance systemic absorption.55,56 Study details relating to dermal Salicylic Acid application and closure of the ductus arteriosus and oligohydramnios were not included. Risk Assessment Dermal Salicylic Acid The relative bioavailability of Salicylic Acid following facial application of a 30% Salicylic Acid peeling product (rinse-off product) was quantified by using plasma exposure parameters such as area under the plasma concentration-time curve (AUC) or Cmax values.57 The measured plasma Salicylic Acid levels were then compared to a single oral dose of 650 mg aspirin (acetylsalicylic acid). Upon absorption, aspirin is rapidly converted to Salicylic Acid, which circulates in the blood as salicylate.58 Serum levels of salicylate typically reach a maximum 2 h after ingestion of aspirin. Blood concentrations of salicylate in excess of 300 µg/mL are considered toxic, while the effective concentration range for a therapeutic dose of aspirin is 150-300 µg/mL. 59 The skin peel formulation containing 30% Salicylic Acid (equal to 7.7 mg/kg bw Salicylic Acid for a 60 kg person) was topically applied for 5 min in nine healthy male and female subjects. The mean (SD) Salicylic Acid Cmax was 0.81 (0.32) µg/mL at 1.4 - 3.5 h after topical skin peel application, and was 56.4 (14.2) µg/mL at 0.5 - 1.5 h after oral aspirin administration. 57 The total area under the Salicylic Acid concentration versus time curve (AUC0-∞) was 6.4 µg × h/mL after dermal exposure and 320 µg × h/mL after oral exposure. The resulting AUC-based safety margin ratio was 50:1. In comparison, the estimated Salicylic Acid Cmax and AUC values at the maximum recommended oral aspirin dose (4000 mg, equivalent to 51 mg/kg bw Salicylic Acid for a 60 kg person) are 183 μg/mL and 1008 μg × h/mL, respectively. When compared to the Cmax and AUC values at 30% Salicylic Acid rinse-off dermal dose, safety margin ratios of 229:1 and 158:1 for Cmax and AUC, respectively, have resulted.60 These results suggest a wide margin of safety with 30% Salicylic Acid use in rinse-off peeling products; when using human plasma exposure data, a margin of safety (MOS) of 10 is considered sufficient to ensure the safety of human exposure.60,61 The mean Salicylic Acid Cmax of 0.81 µg/mL at 1.4 - 3.5 h after topical application of the peel product was compared to the blood concentrations of salicylate that are considered toxic (> 300 µg/mL) 58 as well as the blood concentrations of Salicylic Acid that are associated with salicylism (> 35 mg/dL [= 350 µg/mL]).62 The results of these comparisons indicate that the blood concentration of Salicylic Acid resulting from application of the peel product (0.81 µg/mL) is substantially lower when compared to an approximation of the lowest blood concentration that is considered toxic (MOS = 300 µg/mL ÷ 0.81 µg/mL = 370), or an approximation of the lowest blood concentration that is associated with salicylism (MOS = 350 µg/mL ÷ 0.81 µg/mL = 432). In order to determine the systemic burden after topical use of a skin care leave-on formulation (face and general creams) containing Salicylic Acid, another risk assessment was performed, taking into consideration the accumulative dose exposure to three leave-on skin care product types: body lotion, face cream, and hand cream. According to the Council’s survey, Salicylic Acid is currently used in face and neck leave-on products at concentrations up to 2%, and in body and hand leave-on products at concentrations up to 0.2%.18 For the purpose of this risk assessment, the estimated daily human exposure level to body lotion, face cream, and hand cream are 7.82, 1.54, and 2.16 g/day, respectively.63 In a risk assessment conducted by SCCNFP, a NOAEL of 75 mg/kg/day, derived from several rat oral teratogenicity studies on Sodium Salicylate, Acetyl Salicylate, Methyl Salicylate or Salicylic Acid, was used in the MOS calculation.5 According to the test procedures, acetylsalicylic acid or Salicylic Acid was administered orally at various times during pregnancy (e.g., days 8 to 14 of gestation, days 9 and 11 of gestation, or days 7 to 17 of gestation) at daily doses of 75 to 500 mg/kg in rats. The results indicated that Salicylic Acid was neither teratogenic nor embryotoxic up to 75 mg/kg/day, and this NOAEL was derived from a series of animal studies in which Sodium Salicylate, Acetyl Salicylate, Methyl Salicylate, or Salicylic Acid were orally administered in rats. Above such dose, fetal malformations (skeletal malformations, cleft lip), resorptions and perinatal death were observed. Furthermore, in consideration of all available in vitro and in vivo data regarding human percutaneous absorption from topically applied Salicylic Acid, a dermal absorption value of 50% is chosen,60 which also corresponds to the default absorption value proposed by SCCS.63 For leave-on skin care products, the relevant calculations are: Systemic exposure dose (SED) of body lotion = 7.82 g/day of product × 0.2 % maximum use concentration ÷ 60 kg person × 50% skin absorption × 1000 mg/g conversion factor = 0.130 mg/kg/day SED of face cream = 1.54 g/day of product × 2 % maximum use concentration ÷ 60 kg person × 50% skin absorption × 1000 mg/g conversion factor = 0.257 mg/kg/day SED of hand cream = 2.16 g/day of product × 0.2 % maximum use concentration ÷ 60 kg person × 50% skin absorption × 1000 mg/g conversion factor = 0.036 mg/kg/day Overall SED (leave-on skin care products, body lotion + face cream + hand cream) = 0.130 + 0.257 + 0.036 = 0.423 mg/kg/day MOS (leave-on skin care products) = NOAEL (rat oral teratogenicity study) / Overall SED (sum of the three leave-on skin care products SEDs) = 75 mg/kg/day / 0.423 mg/kg/day = 177 Plasma Cmax and AUC values are available from kinetic studies involving applications of 2% Salicylic Acid leave-on formulations (either in cream or hydroalcoholic liquid) for 14 days, which resulted in a topical daily exposure to 0.45 mg/kg bw Salicylic Acid.64 The AUC values for the cream and hydro-alcoholic formulations were about 366- to 252-fold lower than the AUC value from daily recommended oral therapeutic dose of aspirin (4000 mg, equivalent to 51 mg/kg bw Salicylic Acid).60,64 In a kinetic-based safety assessment, total aggregate systemic exposure to Salicylic Acid from cosmetic products was calculated as 1.25 mg/kg bw/day, which yielded the Cmax and AUC values of Salicylic Acid in human plasma at 7.0 μg/mL and 22 μg × h/mL, respectively. When compared to the estimated Salicylic Acid Cmax and AUC values at the maximum recommended oral aspirin dose (183 μg/mL and 1008 μg × h/mL, respectively), the safety margins of 25- and 44- fold have resulted.60 Butyloctyl Salicylate The following risk assessment was performed, taking into consideration that the maximum use concentration of 35.9% Butyloctyl Salicylate in lipsticks exceeds IFRA’s 1% concentration limit (relative to sensitization potential) for Butyloctyl Salicylate in lip products of all types, and because of systemic toxicity concerns due to the potential for metabolism to salicylic acid. 27 The Council survey of maximum reported use concentrations conducted in 2018 indicates that Butyloctyl Salicylate is being used at concentrations up to 35.9% in leave-on products (lipstick), which is the highest maximum use concentration.18 In accordance with the SCCS Notes of Guidance, the estimated daily exposure level for lipstick is 0.057g.63 Thus, a total dose of Butyloctyl Salicylate exposure during the application of lipstick can be estimated: SED of lipstick= 0.057 g/day of product × 35.9% maximum use concentration ÷ 60 kg person × 100% skin absorption × 1000 mg/g conversion factor = 0.34105 mg/kg/day MOS (Butyloctyl Salicylate, lipstick) = NOAEL (from rat oral teratogenicity studies; see above) / SED = 75 mg/kg/day /0.1705 mg/kg/day = 220 Oral Salicylic Acid An exposure assessment of a representative cosmetic product (containing ≤ 2% Salicylic Acid) used on a daily basis estimated that the exposure from the cosmetic product would be only 20% of the level seen with ingestion of a “baby” aspirin (81 mg) on a daily basis. This exposure assessment further contends that the reproductive and developmental toxicity from the daily use of a baby aspirin is not significant.

General safety info about Isocetyl Salicylate from CIR

The Cosmetic Ingredient Review (CIR) Expert Panel reviewed the safety of Salicylic Acid and 17 salicylates; 15 of these ingredients were previously reviewed by the Panel, and 3 are reviewed herein for the first time. Some of the reported functions in cosmetics for ingredients in this group are hair and skin conditioning agents, and, less frequently, preservatives and fragrance ingredients. Upon review of relevant new data, including frequency and concentration of use, and consideration of data from the previous CIR report, the Panel concluded that Salicylic Acid and 17 salicylate ingredients are safe in cosmetics in the present practices of use and concentration described in the safety assessment when formulated to be non-irritating and non-sensitizing, which may be based on a quantitative risk assessment (QRA).

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Products where you might find Isocetyl Salicylate

Erborian CC Cream Radiance Color Corrector Broad Spectrum SPF25; Erborian CC Cream Radiance Color Corrector Broad Spectrum SPF25 Mini