Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure
Justification for type of information:
The registered substance is a complex UVCB reaction mixture of sulphonated linear and branched alkaryl substituted aromatic hydrocarbon salts. The substance is marketed as a solution in commercially available mineral oil, but in the absence of the mineral oil is an amorphous glass-like material.
Data are available for the one-generation reproduction toxicity study are available by read across. This data demonstrated a complete lack of effects due to administration of the test sample.
Furthermore, the substance is supplied and used commercially in mineral oil and typically supplied at low concentration in final products. There is extremely low human exposure to the substance in use.
Data are available to demonstrate that are adequate for classification of the substance.
To avoid unnecessary testing on vertebrate animals, further data are considered unnecessary, in line with ECHA’s commitment to avoid unnecessary animal testing.

Data source

Materials and methods

Test animals

Species:
rat

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Based upon the toxicological data available, including the reproduction toxicity study available, and taking account of animal welfare consideration, there is no evidence that the substance is likely to have any developmental toxicity effect. It is therefore considered not scientifically justified to undertake a development toxicity study in animals

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