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Administrative data

Key value for chemical safety assessment

Additional information

In-vitro gene mutation study in bacteria:

Key study: Read-across approach from experimental data on the analogue OS2600:

An in-vitro bacterial reverse assay (Ames test) was performed on the analogue OS2600 in accordance with OECD Guideline 471 (GLP study). Salmonella typhimurium, strains TA1535, TA1537, TA98 and TA100 and Escherichia coli, strain WP2 uvrA (pKM101), were exposed to OS2600 diluted in dimethyl sulphoxide (DMSO) up to 5000 µg/plate with and without metabolic activation. OS2600 did not induce a significant dose-related increase in the number of revertant colonies in any tested strain and therefore, it was determined to be non-mutagenic under the test conditions. Based on the read-across approach, OS3600 was determined to be non-mutagenic.

Key study: Read-across approach form experimental data on the analogue OS1600:

An in-vitro bacterial reverse assay (Ames test) was performed on the analogue substance OS1600 in accordance with OECD Guideline 471 (GLP study). Salmonella typhimurium, strains TA1535, TA1537, TA98 and TA100 and Escherichia coli, strain WP2 uvrA (pKM101), were exposed to OS1600 diluted in dimethyl sulphoxide (DMSO) up to 5000 µg/plate. DMSO was also used as a negative control. No evidence of mutagenic activity was seen at any concentration of OS1600 in either mutation test. Based on these results, the read-across approach was applied and the OS3600 was determined to be non-mutagenic.

In-vitro gene mutation study in mammalian cells:

Key study: Read-across approach from experimental data on the analogue substance OS1600:

An in-vitro mutation test using Mouse Lymphoma L5178Y Cells was performed in accordance with OECD Guideline 476 (GLP study). Based on the read-across approach from experimental data on the analogue substance OS1600 (where cultures were exposed up to 3435.5 µg/mL for 3 h and/or 24 h with and without metabolic activation and no increases in the mean mutant frequencies exceeded the sum of the mean concurrent vehicle control mutant frequency and the Global Evaluation Factor), the OS9600 was determined to have no mutagenic potential under the test conditions.

In-vitro cytogenicity study in mammalian cells:

Key study. Read-across approach from experimental data on the analogue substance OS1600:

A study was performed to assess the ability to induce chromosomal aberrations in human lymphocytes cultured in vitro in accordance with OECD Guideline 473 (GLP study). Based on the read-across approach from experimental results on the analogue OS1600 (where cultures were exposed >= 3250 µg/mL with metabolic activation for 3h caused an increase in the frequency of structural chromosome aberration, but instead, the results were negative for cultures treated without metabolic activation), it was concluded that the substance OS3600 could cause structural chromosome aberrations in the presence of metabolic activation under test the in-vitro cytogenetic test conditions.

In-vivo micronucleus assay:

Key study: Read-across approach from experimental data on the analogue substance OS1600:

An in-vivo micronucleus test in Crl: CD(SD) rats was performed according to OECD Guideline 474 (GLP study). Based on the read-across approach from the experimental data on the analogue substance OS1600 (no evidence of causing an increase in the induction of micronucleated polychromatic erythrocytes or bone marrow cell toxicity in male rats when administered up to 500 mg/kg bw orally by gavage), the substance OS3600 was also determined to be negative for the in-vivo micronucleus test.

Based on this battery of in vitro and in vivo test, the weight of evidence indicate that OS3600 is non-genotoxic.


Justification for selection of genetic toxicity endpoint
No study was selected, since all genetic toxicity studies were negative.

Short description of key information:
Based on the read-across approach from the analogue substance OS1600, OS3600 was determined to be not mutagenic (in vivo and in vitro genetic toxicology studies indicates not genotoxic).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available experimental data, OS3600 was determined to be non-genotoxic, and therefore it is not classified in accordance with CLP Regulation (EC) no. 1727/2008.