codes .............................................. 8, codes ............................................... 8, for purposes other than inhibiting

SOURCE_SUBDIR=sccs_o_244; REPORT_TITLE=OPINION on Homosalate; OPINION_NUMBER=SCCS/1622/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2021; VALUE_TEXT=75; DOSE=Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the safety assessment of homosalate (60 mg/kg bw/d).; LOAEL_VALUE=60 mg/kg bw/d; EFFECT=endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. It was brought up during the commenting period that homosalate is metabolized to e.g. salicylic acid which is considered as endocrine disruptor by the Danish EPA. However, salicylic acid is not the only metabolite formed from homosalate (see chapter on toxicokinetics above). Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the safety assessment of homosalate (60 mg/kg bw/d). 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) The calculation of the systemic exposure dose (SED) was carried out as laid down in the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 11th revision, adopted during the plenary meeting of 30-31 March 2021 (SCCS/1628/21). CALCULATION OF TH; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-56-9","citation":"","dose":"Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the safety assessment of homosalate (60 mg/kg bw/d).","duration":"","effect":"endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. It was brought up during the commenting period that homosalate is metabolized to e.g. salicylic acid which is considered as endocrine disruptor by the Danish EPA. However, salicylic acid is not the only metabolite formed from homosalate (see chapter on toxicokinetics above). Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the safety assessment of homosalate (60 mg/kg bw/d). 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) The calculation of the systemic exposure dose (SED) was carried out as laid down in the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 11th revision, adopted during the plenary meeting of 30-31 March 2021 (SCCS/1628/21). CALCULATION OF TH","endpoint":"","ingredient":"codes .............................................. 8","loael_value":"60 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"75","page":47,"route":"","species":"human","study_id":"sccs_o_244_noael_006"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_244; REPORT_TITLE=OPINION on Homosalate; OPINION_NUMBER=SCCS/1622/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2021; VALUE_TEXT=75; DOSE=Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the assessment of homosalate (60 mg/kg bw/d).; LOAEL_VALUE=60 mg/kg bw/d; EFFECT=endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. It was brought up during the commenting period that homosalate is metabolized to e.g. salicylic acid which is considered as endocrine disruptor by the Danish EPA. However, salicylic acid is not the only metabolite formed from homosalate (see chapter on toxicokinetics above). Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the assessment of homosalate (60 mg/kg bw/d). The SCCS assessment did not cover the safety of homosalate for the environment.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-56-9","citation":"","dose":"Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the assessment of homosalate (60 mg/kg bw/d).","duration":"","effect":"endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. It was brought up during the commenting period that homosalate is metabolized to e.g. salicylic acid which is considered as endocrine disruptor by the Danish EPA. However, salicylic acid is not the only metabolite formed from homosalate (see chapter on toxicokinetics above). Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the assessment of homosalate (60 mg/kg bw/d). The SCCS assessment did not cover the safety of homosalate for the environment.","endpoint":"","ingredient":"codes .............................................. 8","loael_value":"60 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"75","page":51,"route":"","species":"human","study_id":"sccs_o_244_noael_013"}

SCCS Opinion

{"dose":"Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the safety assessment of homosalate (60 mg/kg bw/d).","effect":"endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. It was brought up during the commenting period that homosalate is metabolized to e.g. salicylic acid which is considered as endocrine disruptor by the Danish EPA. However, salicylic acid is not the only metabolite formed from homosalate (see chapter on toxicokinetics above). Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the safety assessment of homosalate (60 mg/kg bw/d). 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) The calculation of the systemic exposure dose (SED) was carried out as laid down in the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 11th revision, adopted during the plenary meeting of 30-31 March 2021 (SCCS/1628/21). CALCULATION OF TH","page":47,"pdf":"sccs_o_244.pdf","row_type":"noael_study","study_id":"sccs_o_244_noael_006"}

SCCS Opinion

{"dose":"Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the safety assessment of homosalate (60 mg/kg bw/d).","effect":"endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. It was brought up during the commenting period that homosalate is metabolized to e.g. salicylic acid which is considered as endocrine disruptor by the Danish EPA. However, salicylic acid is not the only metabolite formed from homosalate (see chapter on toxicokinetics above). Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the safety assessment of homosalate (60 mg/kg bw/d). 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) The calculation of the systemic exposure dose (SED) was carried out as laid down in the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 11th revision, adopted during the plenary meeting of 30-31 March 2021 (SCCS/1628/21). CALCULATION OF TH","page":47,"pdf":"sccs_o_244.pdf","row_type":"noael_study","study_id":"sccs_o_244_noael_006"}

SCCS Opinion

{"dose":"Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the safety assessment of homosalate (60 mg/kg bw/d).","effect":"endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. It was brought up during the commenting period that homosalate is metabolized to e.g. salicylic acid which is considered as endocrine disruptor by the Danish EPA. However, salicylic acid is not the only metabolite formed from homosalate (see chapter on toxicokinetics above). Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the safety assessment of homosalate (60 mg/kg bw/d). 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) The calculation of the systemic exposure dose (SED) was carried out as laid down in the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 11th revision, adopted during the plenary meeting of 30-31 March 2021 (SCCS/1628/21). CALCULATION OF TH","page":47,"pdf":"sccs_o_244.pdf","row_type":"noael_study","study_id":"sccs_o_244_noael_006"}

SCCS Opinion

{"dose":"Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the safety assessment of homosalate (60 mg/kg bw/d).","effect":"endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. It was brought up during the commenting period that homosalate is metabolized to e.g. salicylic acid which is considered as endocrine disruptor by the Danish EPA. However, salicylic acid is not the only metabolite formed from homosalate (see chapter on toxicokinetics above). Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the safety assessment of homosalate (60 mg/kg bw/d). 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) The calculation of the systemic exposure dose (SED) was carried out as laid down in the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 11th revision, adopted during the plenary meeting of 30-31 March 2021 (SCCS/1628/21). CALCULATION OF TH","page":47,"pdf":"sccs_o_244.pdf","row_type":"noael_study","study_id":"sccs_o_244_noael_006"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=unclear:Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal; DOSE=The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal; EFFECT=Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal","duration":"","effect":"Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal","endpoint":"","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"","noael_value":"unclear:Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal","page":50,"route":"","species":"","study_id":"sccs_o_223_noael_016"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=unclear:Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: bioavailability i | n humans | , the oral | NOAEL o | f 75 | mg/kg/day i | s defined as N | OAELsys. The; DOSE=MOS for aggregate systemic exposure to cosmetic products containing salicylic: bioavailability i | n humans | , the oral | NOAEL o | f 75 | mg/kg/day i | s defined as N | OAELsys.; EFFECT=Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: bioavailability i | n humans | , the oral | NOAEL o | f 75 | mg/kg/day i | s defined as N | OAELsys. The; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"MOS for aggregate systemic exposure to cosmetic products containing salicylic: bioavailability i | n humans | , the oral | NOAEL o | f 75 | mg/kg/day i | s defined as N | OAELsys.","duration":"","effect":"Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: bioavailability i | n humans | , the oral | NOAEL o | f 75 | mg/kg/day i | s defined as N | OAELsys. The","endpoint":"","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"","noael_value":"unclear:Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: bioavailability i | n humans | , the oral | NOAEL o | f 75 | mg/kg/day i | s defined as N | OAELsys. The","page":50,"route":"oral","species":"human","study_id":"sccs_o_223_noael_017"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=50; EFFECT=Unlabeled table on page 51: SCCS 2016 Notes of guidance Approach | SCCS Guidance 9th revision*; deterministic additive; maximum % level | 1.50 | 50; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 51: SCCS 2016 Notes of guidance Approach | SCCS Guidance 9th revision*; deterministic additive; maximum % level | 1.50 | 50","endpoint":"","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"","noael_value":"50","page":51,"route":"","species":"","study_id":"sccs_o_223_noael_020"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=75; DOSE=SCCS/1601/18 Final Opinion Opinion on salicylic acid (CAS 69-72-7) - Submission I - Corrigendum of 20-21 June 2019 ___________________________________________________________________________________________ 51 acid Risk Assessment Scenario Basis for exposure assessment Aggregate Systemic Exposure Dose (mg/kg/day) Margin of Safety (using a NOAEL...; EFFECT=SCCS/1601/18 Final Opinion Opinion on salicylic acid (CAS 69-72-7) - Submission I - Corrigendum of 20-21 June 2019 ___________________________________________________________________________________________ 51 acid Risk Assessment Scenario Basis for exposure assessment Aggregate Systemic Exposure Dose (mg/kg/day) Margin of Safety (using a NOAEL of 75 mg/kg/day) Scenario 1 Crème Care and Cosmetics model; probabilistic habits & practices; maximum % level 0.384 195 SCCS 2016 Notes of guidance Approach SCCS Guidance 9th revision*; deterministic additive; maximum % level 1.50 50 * Assumes everybody in the population uses all the products each day, and all products contain salicylic acid, aggregate exposure is calculated on the basis of deterministic additive methods. Applicant’s Analysis In the Applicant’s dossier, evidence is presented to show that human and; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"SCCS/1601/18 Final Opinion Opinion on salicylic acid (CAS 69-72-7) - Submission I - Corrigendum of 20-21 June 2019 ___________________________________________________________________________________________ 51 acid Risk Assessment Scenario Basis for exposure assessment Aggregate Systemic Exposure Dose (mg/kg/day) Margin of Safety (using a NOAEL...","duration":"","effect":"SCCS/1601/18 Final Opinion Opinion on salicylic acid (CAS 69-72-7) - Submission I - Corrigendum of 20-21 June 2019 ___________________________________________________________________________________________ 51 acid Risk Assessment Scenario Basis for exposure assessment Aggregate Systemic Exposure Dose (mg/kg/day) Margin of Safety (using a NOAEL of 75 mg/kg/day) Scenario 1 Crème Care and Cosmetics model; probabilistic habits & practices; maximum % level 0.384 195 SCCS 2016 Notes of guidance Approach SCCS Guidance 9th revision*; deterministic additive; maximum % level 1.50 50 * Assumes everybody in the population uses all the products each day, and all products contain salicylic acid, aggregate exposure is calculated on the basis of deterministic additive methods. Applicant’s Analysis In the Applicant’s dossier, evidence is presented to show that human and","endpoint":"","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":51,"route":"","species":"human","study_id":"sccs_o_223_noael_011"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=75; DOSE=Risk Assessment Scenario | Basis for exposure assessment | Aggregate Systemic Exposure Dose (mg/kg/day) | Margin of Safety (using a NOAEL of 75 mg/kg/day); EFFECT=Unlabeled table on page 51: Risk Assessment Scenario | Basis for exposure assessment | Aggregate Systemic Exposure Dose (mg/kg/day) | Margin of Safety (using a NOAEL of 75 mg/kg/day); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"Risk Assessment Scenario | Basis for exposure assessment | Aggregate Systemic Exposure Dose (mg/kg/day) | Margin of Safety (using a NOAEL of 75 mg/kg/day)","duration":"","effect":"Unlabeled table on page 51: Risk Assessment Scenario | Basis for exposure assessment | Aggregate Systemic Exposure Dose (mg/kg/day) | Margin of Safety (using a NOAEL of 75 mg/kg/day)","endpoint":"","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":51,"route":"","species":"","study_id":"sccs_o_223_noael_018"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=195; EFFECT=Unlabeled table on page 51: Scenario 1 | Crème Care and Cosmetics model; probabilistic habits & practices; maximum % level | 0.384 | 195; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 51: Scenario 1 | Crème Care and Cosmetics model; probabilistic habits & practices; maximum % level | 0.384 | 195","endpoint":"","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"","noael_value":"195","page":51,"route":"","species":"","study_id":"sccs_o_223_noael_019"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=0.1; DOSE=For MoS calculation, SCCS uses the developmental NOAEL of 0.1% (75 mg/kg bw/day) derived from Tanaka et al.; EFFECT=monkey studies and a negative rabbit study), human epidemiology and medical experience, the RAC considered classification of salicylic acid as Repr. 2; H361d (Suspected of damaging the unborn child) to be justified. SCCS comments SCCS agrees with RAC that salicylic acid is a developmental toxicant. Harmonised classification of salicylic acid was recently published in Regulation 2018/1480 and is classified as Repr. 2 (H361d Suspected of damaging the unborn child). For MoS calculation, SCCS uses the developmental NOAEL of 0.1% (75 mg/kg bw/day) derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is also in agreement with the previous SCCNFP Opinion (2002) and is also supported by Tanaka et al. (1973b). 3.3.7 Mutagenicity / genotoxicity 3.3.7.1 Mutagenicity / genotoxicity in vitro From SCCNFP/0522/01/2002 Studies have been performed in order to assess the mutagenic/genotoxic potential of salicylic acid and acetylsal; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"For MoS calculation, SCCS uses the developmental NOAEL of 0.1% (75 mg/kg bw/day) derived from Tanaka et al.","duration":"developmental","effect":"monkey studies and a negative rabbit study), human epidemiology and medical experience, the RAC considered classification of salicylic acid as Repr. 2; H361d (Suspected of damaging the unborn child) to be justified. SCCS comments SCCS agrees with RAC that salicylic acid is a developmental toxicant. Harmonised classification of salicylic acid was recently published in Regulation 2018/1480 and is classified as Repr. 2 (H361d Suspected of damaging the unborn child). For MoS calculation, SCCS uses the developmental NOAEL of 0.1% (75 mg/kg bw/day) derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is also in agreement with the previous SCCNFP Opinion (2002) and is also supported by Tanaka et al. (1973b). 3.3.7 Mutagenicity / genotoxicity 3.3.7.1 Mutagenicity / genotoxicity in vitro From SCCNFP/0522/01/2002 Studies have been performed in order to assess the mutagenic/genotoxic potential of salicylic acid and acetylsal","endpoint":"developmental toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"%","noael_value":"0.1","page":34,"route":"","species":"rabbit","study_id":"sccs_o_223_noael_008"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=5.3; DOSE=days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals.; EFFECT=days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub- cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals.","duration":"developmental","effect":"days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub- cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in","endpoint":"developmental toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"%","noael_value":"5.3","page":31,"route":"dermal","species":"rat","study_id":"sccs_o_223_noael_003"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=75; DOSE=The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.; EFFECT=malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species. Tanaka et al., 1973 a Guideline/method: Equivalent to OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: Rat/Wistar Group size: 20 females per dose Test substance: Test substance: salicylic acid; 0.5% in CMC (carboxymethyl cellulose); No other data Batch: Dose levels: 0.06%, 0.1%, 0.2% and 0.4% in the diet (50.7 ± 0.6, 77.4 ± 1.0, 165 ± 2.1, 205.9 ± 18.9 mg/; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.","duration":"developmental","effect":"malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species. Tanaka et al., 1973 a Guideline/method: Equivalent to OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: Rat/Wistar Group size: 20 females per dose Test substance: Test substance: salicylic acid; 0.5% in CMC (carboxymethyl cellulose); No other data Batch: Dose levels: 0.06%, 0.1%, 0.2% and 0.4% in the diet (50.7 ± 0.6, 77.4 ± 1.0, 165 ± 2.1, 205.9 ± 18.9 mg/","endpoint":"developmental toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":31,"route":"oral","species":"rat","study_id":"sccs_o_223_noael_004"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=75; DOSE=The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.; EFFECT=, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species. Tanaka et al., 1973 a Guideline/method: Equivalent to OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: Rat/Wistar Group size: 20 females per dose Test substance: Test substance: salicylic acid; 0.5% in CMC (carboxymethyl cellulose); No other data Batch: Dose levels: 0.06%, 0.1%, 0.2% and 0.4% in the diet (50.7 ± 0.6, 77.4 ± 1.0, 165 ± 2.1, 205.9 ± 18.9 mg/kg bw/d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.","duration":"developmental","effect":", 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species. Tanaka et al., 1973 a Guideline/method: Equivalent to OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: Rat/Wistar Group size: 20 females per dose Test substance: Test substance: salicylic acid; 0.5% in CMC (carboxymethyl cellulose); No other data Batch: Dose levels: 0.06%, 0.1%, 0.2% and 0.4% in the diet (50.7 ± 0.6, 77.4 ± 1.0, 165 ± 2.1, 205.9 ± 18.9 mg/kg bw/d","endpoint":"developmental toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":31,"route":"oral","species":"rat","study_id":"sccs_o_223_noael_005"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=75; DOSE=3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) The Margin of Safety is calculated by dividing the toxicological Point of Departure, POD, (in mg/kg/day) by an estimate of the systemic exposure dose (in mg/kg/day) following dermal exposure.; EFFECT=tic uses, it was not possible to include them in the aggregated exposure scenarios. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) The Margin of Safety is calculated by dividing the toxicological Point of Departure, POD, (in mg/kg/day) by an estimate of the systemic exposure dose (in mg/kg/day) following dermal exposure. The MOS's were updated by the SCCS to include a skin penetration of 60% in all calculations of systemic exposure dose. The toxicological POD (75 mg/kg/day) is taken in this case as the NOAEL from the pivotal developmental study by Tanaka et al., 1973a, for the most sensitive toxic endpoint observed in the rat as the most sensitive species. Due to the evidence for high (100%) oral bioavailability in humans, the oral NOAEL of 75 mg/kg/day is defined as NOAELsys. The outcomes for aggregate exposures from the different risk assessment approaches are summarised in Table 22. Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) The Margin of Safety is calculated by dividing the toxicological Point of Departure, POD, (in mg/kg/day) by an estimate of the systemic exposure dose (in mg/kg/day) following dermal exposure.","duration":"developmental","effect":"tic uses, it was not possible to include them in the aggregated exposure scenarios. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) The Margin of Safety is calculated by dividing the toxicological Point of Departure, POD, (in mg/kg/day) by an estimate of the systemic exposure dose (in mg/kg/day) following dermal exposure. The MOS's were updated by the SCCS to include a skin penetration of 60% in all calculations of systemic exposure dose. The toxicological POD (75 mg/kg/day) is taken in this case as the NOAEL from the pivotal developmental study by Tanaka et al., 1973a, for the most sensitive toxic endpoint observed in the rat as the most sensitive species. Due to the evidence for high (100%) oral bioavailability in humans, the oral NOAEL of 75 mg/kg/day is defined as NOAELsys. The outcomes for aggregate exposures from the different risk assessment approaches are summarised in Table 22. Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic","endpoint":"developmental toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":50,"route":"oral","species":"rat","study_id":"sccs_o_223_noael_009"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=75; DOSE=in mg/kg/day) by an estimate of the systemic exposure dose (in mg/kg/day) following dermal exposure.; EFFECT=in mg/kg/day) by an estimate of the systemic exposure dose (in mg/kg/day) following dermal exposure. The MOS's were updated by the SCCS to include a skin penetration of 60% in all calculations of systemic exposure dose. The toxicological POD (75 mg/kg/day) is taken in this case as the NOAEL from the pivotal developmental study by Tanaka et al., 1973a, for the most sensitive toxic endpoint observed in the rat as the most sensitive species. Due to the evidence for high (100%) oral bioavailability in humans, the oral NOAEL of 75 mg/kg/day is defined as NOAELsys. The outcomes for aggregate exposures from the different risk assessment approaches are summarised in Table 22. Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"in mg/kg/day) by an estimate of the systemic exposure dose (in mg/kg/day) following dermal exposure.","duration":"developmental","effect":"in mg/kg/day) by an estimate of the systemic exposure dose (in mg/kg/day) following dermal exposure. The MOS's were updated by the SCCS to include a skin penetration of 60% in all calculations of systemic exposure dose. The toxicological POD (75 mg/kg/day) is taken in this case as the NOAEL from the pivotal developmental study by Tanaka et al., 1973a, for the most sensitive toxic endpoint observed in the rat as the most sensitive species. Due to the evidence for high (100%) oral bioavailability in humans, the oral NOAEL of 75 mg/kg/day is defined as NOAELsys. The outcomes for aggregate exposures from the different risk assessment approaches are summarised in Table 22. Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic","endpoint":"developmental toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":50,"route":"oral","species":"rat","study_id":"sccs_o_223_noael_010"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=150; DOSE=pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.; EFFECT=pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg and the NOAEL (development): 75 mg/kg were identified. Taken from RAC (March 2016) The results of the studies demonstrated that salicylic acid has an embryo-/foetotoxic effect in rats with dose-dependent growth delays, fetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the mechanistic study of Greenaw; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.","duration":"developmental","effect":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg and the NOAEL (development): 75 mg/kg were identified. Taken from RAC (March 2016) The results of the studies demonstrated that salicylic acid has an embryo-/foetotoxic effect in rats with dose-dependent growth delays, fetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the mechanistic study of Greenaw","endpoint":"developmental toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg","noael_value":"150","page":33,"route":"oral","species":"rat","study_id":"sccs_o_223_noael_006"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=150; DOSE=ely, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.; EFFECT=ely, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg and the NOAEL (development): 75 mg/kg were identified. Taken from RAC (March 2016) The results of the studies demonstrated that salicylic acid has an embryo-/foetotoxic effect in rats with dose-dependent growth delays, fetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the mechanistic study of Greenaway (1982) in which teratogenicity of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"ely, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.","duration":"developmental","effect":"ely, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg and the NOAEL (development): 75 mg/kg were identified. Taken from RAC (March 2016) The results of the studies demonstrated that salicylic acid has an embryo-/foetotoxic effect in rats with dose-dependent growth delays, fetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the mechanistic study of Greenaway (1982) in which teratogenicity of","endpoint":"developmental toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg","noael_value":"150","page":33,"route":"oral","species":"rat","study_id":"sccs_o_223_noael_007"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=0.1; DOSE=Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%.; EFFECT=n rats and are summarised in table 9. Table 9. Reproductive and developmental animal studies with salicylic acid. Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%. 0.4%: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2%: growth retardation, skeletal abnormalities. 0.1% and 0.06% no significant adverse effects. NOAEL 0.1% (approx. 75 mg/kg/day) Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26% fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at par; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%.","duration":"developmental","effect":"n rats and are summarised in table 9. Table 9. Reproductive and developmental animal studies with salicylic acid. Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%. 0.4%: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2%: growth retardation, skeletal abnormalities. 0.1% and 0.06% no significant adverse effects. NOAEL 0.1% (approx. 75 mg/kg/day) Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26% fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at par","endpoint":"reproductive toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"%","noael_value":"0.1","page":31,"route":"oral","species":"rat","study_id":"sccs_o_223_noael_001"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=0.1; EFFECT=Table 9. Reproductive a: NOAEL 0.1%; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"","duration":"","effect":"Table 9. Reproductive a: NOAEL 0.1%","endpoint":"reproductive toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"%","noael_value":"0.1","page":31,"route":"","species":"","study_id":"sccs_o_223_noael_013"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=unclear:Table 9. Reproductive a: group | NOAEL 75 mg/ | kg/day; EFFECT=Table 9. Reproductive a: group | NOAEL 75 mg/ | kg/day; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"","duration":"","effect":"Table 9. Reproductive a: group | NOAEL 75 mg/ | kg/day","endpoint":"reproductive toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"","noael_value":"unclear:Table 9. Reproductive a: group | NOAEL 75 mg/ | kg/day","page":31,"route":"","species":"","study_id":"sccs_o_223_noael_014"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=unclear:Table 9. Reproductive a: *From this review, T | ana | ka et al 1 | 97 | 3a is th | e piv | ot | al | study yieldin | g the lowest NOAEL | for the risk; EFFECT=Table 9. Reproductive a: *From this review, T | ana | ka et al 1 | 97 | 3a is th | e piv | ot | al | study yieldin | g the lowest NOAEL | for the risk; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"","duration":"","effect":"Table 9. Reproductive a: *From this review, T | ana | ka et al 1 | 97 | 3a is th | e piv | ot | al | study yieldin | g the lowest NOAEL | for the risk","endpoint":"reproductive toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"","noael_value":"unclear:Table 9. Reproductive a: *From this review, T | ana | ka et al 1 | 97 | 3a is th | e piv | ot | al | study yieldin | g the lowest NOAEL | for the risk","page":31,"route":"","species":"","study_id":"sccs_o_223_noael_015"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=75; DOSE=& 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%.; EFFECT=& 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%. 0.4%: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2%: growth retardation, skeletal abnormalities. 0.1% and 0.06% no significant adverse effects. NOAEL 0.1% (approx. 75 mg/kg/day) Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26% fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub- cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Kos; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"& 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%.","duration":"","effect":"& 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%. 0.4%: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2%: growth retardation, skeletal abnormalities. 0.1% and 0.06% no significant adverse effects. NOAEL 0.1% (approx. 75 mg/kg/day) Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26% fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub- cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Kos","endpoint":"reproductive toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":31,"route":"oral","species":"rat","study_id":"sccs_o_223_noael_002"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=75; DOSE=2 (H361d Suspected of damaging the unborn child).As the developmental effects are the most sensitive effects after repeated exposure to SA, the NOAEL of 75 mg/kg bw/day has been used for the calculation of the MoS.; EFFECT=ess. Reproductive toxicity SCCS concludes that there is insufficient evidence that salicylic acid has an adverse effect on sexual function and fertility. Developmental Toxicity SCCS agrees that salicylic acid can be considered as a developmental toxicant. Harmonised classification of salicylic acid was recently published in regulation 2018/1480 and is classified as Repr. 2 (H361d Suspected of damaging the unborn child).As the developmental effects are the most sensitive effects after repeated exposure to SA, the NOAEL of 75 mg/kg bw/day has been used for the calculation of the MoS. Mutagenicity / genotoxicity The genotoxicity of salicylic acid was investigated with valid genotoxicity tests for in vitro gene mutations, in both bacterial and mammalian test system. Although no valid in vitro test results on chromosomal aberrations were provided, the in vivo chromosomal aberration and sister chromatid exchange tests in mice showed no mutagenic activity of salicylic acid. Based on the submitted studies and available literature, the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"2 (H361d Suspected of damaging the unborn child).As the developmental effects are the most sensitive effects after repeated exposure to SA, the NOAEL of 75 mg/kg bw/day has been used for the calculation of the MoS.","duration":"Developmental","effect":"ess. Reproductive toxicity SCCS concludes that there is insufficient evidence that salicylic acid has an adverse effect on sexual function and fertility. Developmental Toxicity SCCS agrees that salicylic acid can be considered as a developmental toxicant. Harmonised classification of salicylic acid was recently published in regulation 2018/1480 and is classified as Repr. 2 (H361d Suspected of damaging the unborn child).As the developmental effects are the most sensitive effects after repeated exposure to SA, the NOAEL of 75 mg/kg bw/day has been used for the calculation of the MoS. Mutagenicity / genotoxicity The genotoxicity of salicylic acid was investigated with valid genotoxicity tests for in vitro gene mutations, in both bacterial and mammalian test system. Although no valid in vitro test results on chromosomal aberrations were provided, the in vivo chromosomal aberration and sister chromatid exchange tests in mice showed no mutagenic activity of salicylic acid. Based on the submitted studies and available literature, the","endpoint":"reproductive toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"75","page":53,"route":"","species":"mouse","study_id":"sccs_o_223_noael_012"}

SCCS Opinion

{"absorption_percent":"60 %; 60%","basis":"Studies related to the dermal/percutaneous absorption of salicylic acid have been assessed and commented upon by the SCCS in its previous Opinion (SCCS/1601/18) and the results are summarized below: Salicylic acid is readily ionised and skin absorption is significantly affected by pH and other properties of the vehicle in which it is applied. In view of the high variability of dermal penetration values reported in the different studies, the SCCS estimated a dermal absorption rate of 60 % for salicylic acid. This value corresponds to the value of 60% absorption rate used by the Risk Assessment Committee (RAC) in March 2016.","page":14,"pdf":"sccs_o_268.pdf","row_type":"dermal_absorption_study"}

SCCS Opinion

{"absorption_percent":"60 %; 60%","basis":"Studies related to the dermal/percutaneous absorption of salicylic acid have been assessed and commented upon by the SCCS in its previous Opinion (SCCS/1601/18) and the results are summarized below: Salicylic acid is readily ionised and skin absorption is significantly affected by pH and other properties of the vehicle in which it is applied. In view of the high variability of dermal penetration values reported in the different studies, the SCCS estimated a dermal absorption rate of 60 % for salicylic acid. This value corresponds to the value of 60% absorption rate used by the Risk Assessment Committee (RAC) in March 2016.","page":14,"pdf":"sccs_o_268.pdf","row_type":"dermal_absorption_study"}

SCCS Opinion

{"absorption_percent":"60 %; 60%","basis":"Studies related to the dermal/percutaneous absorption of salicylic acid have been assessed and commented upon by the SCCS in its previous Opinion (SCCS/1601/18) and the results are summarized below: Salicylic acid is readily ionised and skin absorption is significantly affected by pH and other properties of the vehicle in which it is applied. In view of the high variability of dermal penetration values reported in the different studies, the SCCS estimated a dermal absorption rate of 60 % for salicylic acid. This value corresponds to the value of 60% absorption rate used by the Risk Assessment Committee (RAC) in March 2016.","page":14,"pdf":"sccs_o_268.pdf","row_type":"dermal_absorption_study"}

SCCS Opinion

SOURCE_SUBDIR=sccs_o_268; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3); OPINION_NUMBER=SCCS/1646/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 June 2023; VALUE_TEXT=75; DOSE=For MoS calculations, the SCCS will use the developmental toxicity NOAEL of 75 mg/kg bw/day derived from Tanaka et al.; EFFECT=the RAC considered classification of salicylic acid as Repr. 2; H361d (Suspected of damaging the unborn child) to be justified. SCCS comments The SCCS maintains its previous opinion (SCCS/1601/18) and agrees with RAC that salicylic acid is a developmental toxicant. Harmonised classification of salicylic acid has recently been published in Regulation 2018/1480, where it has been classified as Repr. 2 (H361d Suspected of damaging the unborn child). For MoS calculations, the SCCS will use the developmental toxicity NOAEL of 75 mg/kg bw/day derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is also in agreement with the previous SCCNFP Opinion (2002) and supported by Tanaka et al. (1973b). 3.5.6 Mutagenicity / genotoxicity A range of studies have been performed to assess the mutagenic/genotoxic potential of salicylic acid. These studies were assessed and commented upon by the SCCS in the previous Opinion (SCCS/1601/18); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"For MoS calculations, the SCCS will use the developmental toxicity NOAEL of 75 mg/kg bw/day derived from Tanaka et al.","duration":"developmental","effect":"the RAC considered classification of salicylic acid as Repr. 2; H361d (Suspected of damaging the unborn child) to be justified. SCCS comments The SCCS maintains its previous opinion (SCCS/1601/18) and agrees with RAC that salicylic acid is a developmental toxicant. Harmonised classification of salicylic acid has recently been published in Regulation 2018/1480, where it has been classified as Repr. 2 (H361d Suspected of damaging the unborn child). For MoS calculations, the SCCS will use the developmental toxicity NOAEL of 75 mg/kg bw/day derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is also in agreement with the previous SCCNFP Opinion (2002) and supported by Tanaka et al. (1973b). 3.5.6 Mutagenicity / genotoxicity A range of studies have been performed to assess the mutagenic/genotoxic potential of salicylic acid. These studies were assessed and commented upon by the SCCS in the previous Opinion (SCCS/1601/18)","endpoint":"developmental toxicity","ingredient":"for purposes other than inhibiting","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"75","page":38,"route":"","species":"","study_id":"sccs_o_268_noael_009"}

SCCS Opinion

{"absorption_percent":"60 %; 60%","basis":"Studies related to the dermal/percutaneous absorption of salicylic acid have been assessed and commented upon by the SCCS in its previous Opinion (SCCS/1601/18) and the results are summarized below: Salicylic acid is readily ionised and skin absorption is significantly affected by pH and other properties of the vehicle in which it is applied. In view of the high variability of dermal penetration values reported in the different studies, the SCCS estimated a dermal absorption rate of 60 % for salicylic acid. This value corresponds to the value of 60% absorption rate used by the Risk Assessment Committee (RAC) in March 2016.","page":14,"pdf":"sccs_o_297.pdf","row_type":"dermal_absorption_study"}

SCCS Opinion

{"absorption_percent":"60 %; 60%","basis":"Studies related to the dermal/percutaneous absorption of salicylic acid have been assessed and commented upon by the SCCS in its previous Opinion (SCCS/1601/18) and the results are summarized below: Salicylic acid is readily ionised and skin absorption is significantly affected by pH and other properties of the vehicle in which it is applied. In view of the high variability of dermal penetration values reported in the different studies, the SCCS estimated a dermal absorption rate of 60 % for salicylic acid. This value corresponds to the value of 60% absorption rate used by the Risk Assessment Committee (RAC) in March 2016.","page":14,"pdf":"sccs_o_297.pdf","row_type":"dermal_absorption_study"}

SCCS Opinion

{"absorption_percent":"60 %; 60%","basis":"Studies related to the dermal/percutaneous absorption of salicylic acid have been assessed and commented upon by the SCCS in its previous Opinion (SCCS/1601/18) and the results are summarized below: Salicylic acid is readily ionised and skin absorption is significantly affected by pH and other properties of the vehicle in which it is applied. In view of the high variability of dermal penetration values reported in the different studies, the SCCS estimated a dermal absorption rate of 60 % for salicylic acid. This value corresponds to the value of 60% absorption rate used by the Risk Assessment Committee (RAC) in March 2016.","page":14,"pdf":"sccs_o_297.pdf","row_type":"dermal_absorption_study"}

SCCS Opinion