Registration Dossier
Registration Dossier
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EC number: 402-130-7 | CAS number: 106246-33-7
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study planned
- Justification for type of information:
- TESTING PROPOSAL:
The test item was found to be non-toxic at the solubility limit in the three acute aquatic toxicity studies on fish, Daphnia and algae; due to the poor water solubility, high log Pow and the lack of biodegradability, we propose to conduct a long-term toxicity study on an aquatic species; however as none of the three tested species showed effects in the acute tests, for animal welfare reasons we suggest to perform a reproduction test over 21 days on Daphnia magna.
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 4,4'-Methylene-bis-(3-chloro-2,6-diethylaniline) / 106246-33-7 / 402-130-7
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: acute toxicity on fish (LC50: > 0.02 mg/L), acute toxicity on Daphnia magna (EC50 > 0.02 mg/l) and algal growth inhibition (EC50 > 0.02 mg/l), no effects noted
- Available non-GLP studies: none
- Historical human data: none
- (Q)SAR: none
- In vitro methods: none
- Weight of evidence: none
- Grouping and read-across: not applicable
- Substance-tailored exposure driven testing [if applicable]: not applicable
- Approaches in addition to above [if applicable]: not applicable
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: exact study design needs to be discussed - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Deviations:
- no
Reference
Description of key information
The test item was found to be non-toxic at the solubility limit in the three acute aquatic toxicity studies on fish, Daphnia and algae; due to the poor water solubility, high log Pow and the lack of biodegradability, we propose to conduct a long-term toxicity study on an aquatic species; however as none of the three tested species showed effects in the acute tests, for animal welfare reasons we suggest to perform a reproduction test over 21 days on Daphnia magna.
Key value for chemical safety assessment
Additional information
Source: GLP-reports and expert assessment
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
