Registration Dossier

Ecotoxicological information

Toxicity to birds

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Administrative data

Endpoint:
long-term toxicity to birds
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
In accordance with Column 2 of REACH Annex X, the long-term or reproductive toxicity to birds (required in Section 9.6.1 of REACH Annex X) does not need to be conducted as the chemical safety assessment according to Annex I indicates that this is not necessary.

Considering
i) The mode of action of the molecule:
- Neutral Organics according to ECOSAR v1.11,
- Class 1 (narcosis or baseline toxicity) according to Verhaar scheme as reported in Toxtree v3.1.0,

This means that the substance will act without a specific toxicity pathway through species;
ii) The overall data available in the dossier, that confirm the lack of specific toxicity specie-dependant on 3 trophic levels while OECD 203, OECD 202 & OECD 201 leads to EC50 > 100 mg/L, and the long term OECD 211 leads to a NOEC > 120mg/L. Moreover, while birds are not mammalian, study on mammalian leads to an oral classification of Acute tox.4 (H302) and no element can reasonably lead to an expected specific toxicity on birds.

Therefore testing does not appear scientifically necessary in accordance with Annex XI section 1.2.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion