Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The substance has no structural alerts for mutagenicity. All three in vitro tests in genetic toxicity (GLP compliant and scored Klimishch 1) showed negative results up to the cytotoxic concentrations. Thus there is no need to carry out in vivo studies in genetic toxicity. There is no reason to believe that the negative results would not be relevant to humans.


Justification for selection of genetic toxicity endpoint
No specific study was selected because all three available in vitro studies were negative. Conclusions are based on the following assays: Bacterial reverse mutation assay (Ames test); Mammalian cell gene mutation assay; In vitro mammalian chromosome aberration test.

Short description of key information:
The results of in vitro studies are negative, both with and without metabolic activation:

- Ames test with S. typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1539 and E coli WP2 uvrA (met. act.: with and without) (OECD TG 471 and 472 and GLP); no toxicity was observed up to a concentration of 50 µg/plate.

- Mammalian cell gene mutation assay with Chinese hamster lung fibroblasts (V79) (met. act.: with and without) (OECD Guideline 476 and GLP); cytotoxicity: preliminary toxicity tests showed a cytotoxicity of 100 µg/mL . The experiments resulted on negative results (no adverse effect observed) up to the 100 µg/mL.

- In vitro mammalian chromosome aberration test with Chinese Hamster Lung (CHL) cells (met. act.: with and without) (OECD Guideline 473 and GLP); cytotoxicity: either structural chromosomal aberrations or polyproidy were not recognized up to a maximum concentration of 0.11 mg/ml (without metabolic activation) and 1.3 mg/ml (with metabolic activation)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Directive 67/548/EEC, Annex 1 and Regulation EC 1272/2008, Annex VI: 1,4 -diethylbenzene is not classified.

Following the criteria as described in Directive 67/548/EEC and Annex 1 of Regulation (EC) No. 1272/2008, and based on the available data, 1,4 -diethylbenzene is not classified for endpoint Germ cell mutagenicity.