Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

- Genetic toxicity in vitro: Bacterial reverse mutation assay:

1.- Key study: Read-across from experimental data on the analogue CAS No. 103-83-3. Equivalent to OECD 471 and 472.

The test substance was not mutagenic to Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA, with or without an exogeneous metabolic activation system.

2.- Key study: Read-across from experimental data on the analogue CAS No. 1477-55-0. Equivalent to OECD 471 and 472.

The substance is not mutagenic with or without metabolic activation under the conditions of the test.

3.- Weight of evidence: Experimental results from scientific articles and reviews. Read-across from experimental data on the analogue CAS No.128-37-0.

The substance is not mutagenic.

- Genetic toxicity in vitro: Mammalian chromosome aberration assay:

1.- Key study: Read-across from experimental data on the analogue CAS No. 103-83-3. Equivalent to OECD 473.

The test substance induced structural chromosomal aberrations with an exogeneous metabolic activation system.

2.- Key study: Read-across from experimental data on the analogue CAS No. 1477-55-0. Equivalent to OECD 473.

The chemical was not clastogenic under the conditions of the assay.

3.- Weight of evidence: Experimental results from scientific articles and reviews. Read-across from experimental data on the analogue CAS No.128-37-0.

The substance did not cause chromosomal aberrations in mammalian cells in vitro.

- Genetic toxicity in vitro: Mammalian cell gene mutation assay:

1.- Key study: Read-across from experimental data on the analogue CAS No. 1477-55-0. Equivalent to OECD 476.

The test material did not induce any toxicologically significant increases in the mutant frequency at the TK +/- locus in L5178Y cells and is therefore considered to be non mutagenic under the conditions of the test.

2.- Weight of evidence: Experimental results from scientific articles and reviews. Read-across from experimental data on the analogue CAS No.128-37-0.

The substance did not cause point mutations in mammalian cells in vitro.

 

- Genetic toxicity in vivo: Chromosome aberration test:

1.- Key study: Read-across from experimental data on the analogue CAS No. 103-83-3. Equivalent to OECD guideline 474.

The test substance did not show any mutagenic activity as determined by the micronucleus test with mouse bone marrow cells.

2.- Weight of evidence: Experimental results from scientific articles and reviews. Read-across from experimental data on the analogue CAS No.128-37-0.

The substance is considered as negative for the genetic toxicity in vivo.


Justification for selection of genetic toxicity endpoint
No study was selected, since the results obtained in the in vitro studies (Ames test and Mammalian cell gene mutation assay) and the results obtained in the in vivo studies (Chromosome aberrations tests) were negative.

Short description of key information:
Bacterial reverse mutation assay (in vitro):
1.Key study: Read-across from experimental data on the analogue CAS No. 103-83-3. Equivalent to OECD 471 and 472.
The test substance was not mutagenic.
2.Key study: Read-across from experimental data on the analogue CAS No. 1477-55-0. Equivalent to OECD 471 and 472.
The substance is not mutagenic.
3.Weight of evidence: Experimental results from scientific articles and reviews. Read-across from experimental data on the analogue CAS No.128-37-0.
The substance is not mutagenic.

Mammalian chromosome aberration assay (in vitro):
1.Key study: Read-across from experimental data on the analogue CAS No. 103-83-3. Equivalent to OECD 473.
The test substance induced structural chromosomal aberrations with an exogeneous metabolic activation system.
2.Key study: Read-across from experimental data on the analogue CAS No. 1477-55-0. Equivalent to OECD 473.
The substance was not clastogenic under the conditions of the assay.
3.Weight of evidence: Experimental results from scientific articles and reviews. Read-across from experimental data on the analogue CAS No.128-37-0.
The substance did not cause chromosomal aberrations.

Mammalian cell gene mutation assay (in vitro):
1.Key study: Read-across from experimental data on the analogue CAS No. 1477-55-0. Equivalent to OECD 476.
The test material is considered to be non mutagenic.
2.Weight of evidence: Experimental results from scientific articles and reviews. Read-across from experimental data on the analogue CAS No.128-37-0.
The substance did not cause point mutations.

Chromosome aberration test (in vivo):
1.Key study: Read-across from experimental data on the analogue CAS No. 103-83-3. Equivalent to OECD guideline 474.
The test substance did not show any mutagenic activity.
2.Weight of evidence: Experimental results from scientific articles and reviews. Read-across from experimental data on the analogue CAS No.128-37-0.
The substance is considered as negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data, the substance is not classified for genetic toxicity.