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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

In vitro

Bacterial cells in vitro:

The substance bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc (CAS No. 42405-40-3) was tested in three in vitro gene mutation study in bacteria (Reverse Mutation Assay, Ames Test).

Two guideline assays found the substance was negative with and without metabolic activation. The assay chosen as the key study was performed in accordance with GLP and according to OECD 471 guidelines. Cytotoxicity was observed so dosing was adequate. None of the strains tested showed evidence of mutagenic activity, either in the absence or in presence of S9 mix.

Mammalian cells in vitro

Chromosome aberration

The substance bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc (CAS No. 42405-40-3) was tested in four in vitro chromosome abberration assays in mammalian cells (in vitro mamamalian cytogenicity assay). In the key study the substance was tested in CHO cells with and without S9. There were no treatment-realted significant increases in structural chromosomal aberrations were seen following 21 hour non-activated treatments or 4 hour treatments with S-9. The substance is therefore considered to be non-clastogenic to CHO cells in vitro.

In vivo

In one guideline in vivo micronucleus assay, bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc (CAS No. 42405-40-3) was tested at 1000 mg/kg in 5 male and female animals at 24h, 48h and 72h. There was no significant decrease in the ratio of poly-to normochromatic erythorcytes at any of the three sacrifice times after treatment with the test substance. Therefore, the substance was considered to be negative in an in vivo micronucleus assay .



Justification for selection of genetic toxicity endpoint
OECD Guideline and GLP compliant study

Short description of key information:
In vitro:
Gene Mutation (Bacterial Reverse Mutation Assay/Ames test): bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc (CAS No. 42405-40-3) did not show mutagenic activity using S. typhimurium TA 1535, TA 1537, TA 98, TA 100 in the presence or absence of metabolic activation.

Chromosome aberration (Mammalian in vitro cytogenicity): bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc (CAS No. 42405-40-3) did not display clastogenic activity in this assay.

In vivo:
Chromosome aberration (in vivo micronucleus assay): bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc (CAS No. 42405-40-3) was found to be negative in an in vivo micronucleus assay.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available information in the dossier, the substance bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc (CAS No. 42405-40-3) does not need to be classified for genetic toxicity when the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC are applied.