Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
long-term toxicity to birds: reproduction test
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACH Regulation (EC) No 1907/2006, Annex X, reproductive toxicity tests to birds (required in section 9.6.1) do not need to be conducted as a mammalian dataset is available (see toxicological studies). According to its physico-chemical properties lithium hydroxide is not expected to be distributed into soil and the ad-/desorption behaviour does not indicate that lithium will be present in the soil. The log Kd value for soil was found to be 2.57, i.e. adsorption potential to soil can be regarded as neglible (refer to IUCLID section 5.4). According to the available information, an input via sludge application on agricultural soil is considered to be negligible, as lithium hydroxide does not adsorb to the sewage sludge to a significant extent. It can be concluded, that the risk for birds / the terrestrial compartment is low and no further information and/or testing is needed.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Categories Display