Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Although no guideline multi-generation reproductive study was identified for TFE, other useful data are available from 90 -day repeat dose toxicity studies in the rat to address this end-point. There was no evidence of adverse effects on the reproductive organs in these studies, in particular from the 90 -day study conducted by the US NTP, in which no differences in sperm morphology parameters or in the length of the oestrous cycles between control and exposed rats were observed. In addition, the need to conduct a study for this end-point is precluded by the fact that it is known to be carcinogenic in laboratory animals. The consequential risk reduction measures that are put in place will ensure adequate protection for any potential residual effects on the reproductive system. This conclusion is supported by the fact that the occupational exposure assessment performed in the CSR predicts that exposures will be below the derived DNEL for TFE, which is based on carcinogenic effects.

Effects on developmental toxicity

Additional information

No guideline developmental toxicity study was identified for TFE. The need to conduct a study on this end-point on TFE is precluded by the fact that it is known to be carcinogenic in laboratory animals. The consequential risk reduction measurements that are put in place will ensure adequate protection for any potential residual effects on the developing offspring. This conclusion is supported by the fact that the occupational exposure assessment performed in the CSR predicts that exposures will be below the derived DNEL for TFE, which is based on its carcinogenic effects.

Justification for classification or non-classification