Registration Dossier
Registration Dossier
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EC number: 202-180-8 | CAS number: 92-70-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
3-Hydroxy-2-naphthoic acid was judged non-mutagenic in an Ames test [ KEY_471_1982_Hoechst_370/82], but caused chromosomal damage in V79 hamster cells in vitro (only in the absence, but not in the presence of metabolic activation) [ NONKEY_473_1989_Hoechst_89.0025]. No clastogenic activity and no toxicity was observed in vivo in bone marrow cells of hamsters dosed with the maximum recommended dose of 2000 mg/kg bw suspended in starch mucilage [ KEY_475_1993_Hoechst_93.0733]. Similarly two negative DNA repair tests on human fibroblasts [NONKEY_482_1985_BASF_850185 and 850186] gave no reason to assume any mutagenic properties.
According to the SIDS Initial Assessment Report for SIAM 19 (3-Hydroxy-2-naphthoic acid) of October 2004, the in vivo study was insufficient to discount the chromosomal damage attained in the vitro study, because of limitations to the in vivo study. In the latter study only 50 metaphases were examined per animal and there was no indication that the target tissue was reached by the test substance. However, in further studies for acute toxicity, repeated dose toxicity, and reproductive toxicity clear treatment related effects were evident, demonstrating that the test substance or its metabolites reach the general circulation and cause systemic toxicity after oral application. Thus, evidence is available, that the test substance will reach the target tissue. In addition available data based on the examination of 50 metaphases do not indicate a likelihood of differing results when evaluating 100 metaphases as intended by the guideline.
Short description of key information:
Ames Test [ KEY_471_1982_Hoechst_370/82]:
negative
Chromosome Aberration Test in vitro [ NONKEY_473_1989_Hoechst_89.0025]:
negative (with metabolic activation),
postive (without metabolic activation)
DNA repair tests on human fibroblasts [NONKEY_482_1985_BASF_850185 and 850186]:
negative
Chromosome Aberration Test in vivo [ KEY_475_1993_Hoechst_93.0733]:
negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Findings of available in vitro (OECD 472, OECD 473, OECD 482) and in vivo (OECD 475) mutagenicity tests do not meet criteria for classification as germ cell mutagen.
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