Final

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_o_223.pdf