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Administrative data

Key value for chemical safety assessment

Additional information

DEGDBE was not mutagenic in the in-vitro battery consisted of Ames test, HPRT and Chromosome aberration test.

Based on that no genotoxicity potential can be assigned.

With respect to the read-across approach used for the endpoints repeated dose toxicity, developmental toxicity and skin sensitization potential, it may be worth mentioning the carcinogenicitiy of EGBE observed in rats and mice. It is reported that EGBE induced forestomach tumour and hemangiosarcomas (summarized in EU Risk Assessment). But these effects were evaluated by EU and IARC not relevant for humans. No concern is derived with respect to carcinogenicity for EGBE.

Justification for selection of genetic toxicity endpoint
Three in-vitro tests are available (Ames test, Chromosome aberration test, HPRT). All three studies are considered to be equally valid.

Short description of key information:
No genotoxicity found in in-vitro tests.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No classification is derived based on the in-vitro data.