Registration Dossier

Administrative data

Endpoint:
fish early-life stage toxicity
Type of information:
experimental study planned
Study period:
2019 - 2021 (an updated dossier has to be submitted by 28 June 2021)
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 2-amylanthraquinone (reaction mixture of 2-(1,1-dimethylpropyl)-9,10-anthraquinone and 2-(1,2-dimethylpropyl)-9,10-anthraquinone).


CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:

- Available GLP studies: no GLP-compliant chronic toxicity studies with fish are available

- Available non-GLP studies: no non-GLP chronic toxicity studies with fish are available

- Historical human data: not applicable

- (Q)SAR: the estimation of chronic toxicity values for fish was performed with ECOSAR for two isomers, 2-(1,1-dimethylpropyl)-9,10-anthraquinone (CAS 32588-54-8) and 2-(1,2-dimethylpropyl)-9,10-anthraquinone (CAS 68892-28-4). The estimated values were 136 µg/L and 144 µg/L for 2-(1,1-dimethylpropyl)-9,10-anthraquinone and 2-(1,2-dimethylpropyl)-9,10-anthraquinone, respectively. However, ECOSAR does not provide information to which stage of the fish lifecycle these values are applicable. Among the currently available standardised test methods, the FELS toxicity test is considered as the most sensitive of the fish tests. It covers several life stages of the fish from the newly fertilised egg, through hatch to early stages of growth and is also the only suitable test currently available for examining the potential toxic effects of bioaccumulation. It cannot thus be excluded that lower effect values will be observed in the FELS test, due to higher sensitivity and lipophilicity of the fertilized eggs.

- In vitro methods: there are no suitable in vitro methods to investigate this endpoint.

- Weight of evidence: no chronic toxicity data on fish are available for 2-amylanthraquinone.

- Grouping and read-across: To prevent a FELS study with 2-amylanthraquinone a read across to other substances could have been used. A logic approach would be to do a read across to other alkylanthraquinones. However a FELS study is not available for 2-pentylanthraquinone (CAS number 13636-21-5), 2-butylanthraquinone, 2-propylanthraquinone or 2-ethylanthraquinone (CAS number 84-51-5). Therefore a read across to other substances is not possible.

- Substance-tailored exposure driven testing [if applicable]: not applicable

- Approaches in addition to above [if applicable]: not applicable

- Other reasons [if applicable]: Instead of doing a chronic study with fish it could have been possible to do a chronic study with a non-vertebrate aquatic organism. However it is preferable to do chronic studies with species representing different trophic levels. Because there are a chronic study with algae (primary producer) and water fleas (primary consumer) available, it is logical to perform a study with fish (secondary consumer). In addition fish are considered important by society.
See further the IUCLID field “Overall remarks” below for more relevant considerations. These are not mentioned in this field, as otherwise these would be published on the ECHA website

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
Not applicable

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: The study will be performed in accordance with OECD guideline 210.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Test material

Constituent 1
Test material form:
liquid: viscous
Details on test material:
- Appearance: Yellow viscous liquid
- Storage conditions: At room temperature protected from light

Results and discussion

Applicant's summary and conclusion