Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Absence of adverse effects in male and female reproductive organs after microscopic examination in two 28-day studies via dermal and inhalation exposure are described in the repeated dose toxicity section. In the 28-day inhalation study statistically significant increases in bodyweight-relative testes weights were recorded but microscopic examination found no evident structural change. Ovaries and uteri were examined with no adverse effects recorded. Spermatogenesis was recorded in both high dose and control animals in the 28-day dermal (rabbit) study, suggesting no effects on male fertility; no adverse effects on female reproductive organs were noted in this study. The conduct of a new study of Renewable Diesel reproductive toxicity is not justified since it is expected that test data for a close structural analogue will become available: it is known to this registrant that a testing proposal for a rat 2-generation reproduction study of straight run gas oils has been submitted within the Lead Registrant registration dossier for that substance.


Short description of key information:
Information from repeated dose studies where reproductive organs were microscopically examined and no adverse effects were recorded.

Effects on developmental toxicity

Description of key information
Equivalent EC method study assessing teratogenicity using diesel fuel via inhalation route.  Good quality study useful for assessment of this endpoint.
Additional information

In a teratology study conducted with Diesel Fuel, pregnant female rats were exposed the test substance via whole-body inhalation on days 6 to 15 of gestation. Decreased food consumption was seen in the high dose group, however, no treatment-related effects were observed in the test substance groups compared to the controls. There was no evidence of inhibition of foetal growth and development or variation in sex ratio in the group exposured to the test substance. The NOAEC for teratogenicity and maternal toxicity is 401.5 ppm.

Justification for classification or non-classification

Based on available developmental/teratology data on diesel fuel, no classification for effects on development is proposed for Renewable Diesel. No two-generation reproductive toxicity data are available for Renewable Diesel or structural analogues: however such a study has been proposed for the anaalogue straight run gas oils. At present there is insufficient data to assess classification as toxic for reproduction under 67/548/EEC and CLP regulation (1272/2008/EC), with particular reference to effect on fertility. Available analogue test data for developmental toxicity indicate no selective foetotoxicity or teratogenic activity.  Renewable Diesel is not classified for reproductive toxicity.