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Administrative data

sediment toxicity: long-term
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
In accordance with
- Column 2 of REACH Annex X,
- REACH Annex XI, section 1, paragraph 1.2,
- Guidance on Information Requirements and chemical Safety Assessment, Chapter R.7b: Endpoint specific guidance, V. 4.0, June 2017,

The long-term toxicity to sediment organisms (required in Section 9.5.1 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 and;
- There is enough scientific evidence to avoid further testing.

Indeed, considering
i) 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, which indicates the lack of ecotoxicity in aquatic organisms,
ii) 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,

Which means that the substance will act without a specific toxicity pathway throughout species;
iii) The partition coefficient (Log Kow) value of 1.1 that indicates that the substance will not adsorb or bind to the sediment,
iv) The absence of biotic or abiotic degradation that would lead to metabolites of concerns,
v) All the RCR were below the threshold of 1,

Testing does not appear scientifically necessary in accordance with Annex XI section 1.2. as no additional adverse effect from sediment organisms is expected.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion