Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Adequacy of study:
weight of evidence
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Data source

Materials and methods

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
This conclusion, for the oral route, is applicable to other routes in terms of “Not classified - based on weight-of-evidence analysis”.
There are no data concerning effects on breastfed babies after treatment of their mothers. However such data are not required by REACH in the present situation. The conclusion is “Not classified - no data, none required” (for all routes).
Executive summary:

The substance has been demonstrated in animals, in adequate studies, to be devoid of adverse effects towards fertility and development (the latter conclusion being of screening value due to the limited extent of examination of pups in the OECD 422 study). Human data are consistent with these conclusions. The conclusion is “Not classified - based on specific, valid data on the substance”. This conclusion, for the oral route, is applicable to other routes in terms of “Not classified - based on weight-of-evidence analysis”.

There are no data concerning effects on breastfed babies after treatment of their mothers. However such data are not required by REACH in the present situation. The conclusion is “Not classified - no data, none required” (for all routes).

Considering REACH Annex IX 8.7.2 and 8.7.3 criteria alone, a developmental toxicity study and a two-generation study in one species should be proposed as the substance is not genotoxic or toxic to reproduction according to available data, and there are no data on plasmatic exposure after dosing. However, although no exemption can be derived from these criteria, it should be underlined that it seems irrelevant to propose and perform this test, both from scientific and regulatory standpoints:

-     the substance is clearly non-toxic based on the available tests including evaluations of fertility and development,

-     it is expected to be metabolised into endogenous compounds,

-     the expected metabolism and excretion do not suggest any bioaccumulation potential,

-     exposure of workers is negligible when taking into account the high particle size limiting dermal and respiratory absorption , and the various risk management measures which are applied by SEPPIC ,

the risk assessment for consumers of the final cosmetic product is exempted under REACH, Directive 2003/15/EC forbids in vivo testing on cosmetic ingredients for the dossier of the final cosmetic product from March 2009, and cosmetic regulations are stated to prevail over REACH requirements.