Registration Dossier
Registration Dossier
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EC number: 260-252-4 | CAS number: 56539-66-3
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- experimental study planned
- Study period:
- To be performed within time frame given by ECHA.
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- 3-Methoxy-3-methylbutanol (MMB)
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: there are no GLP studies available to address this endpoint
- Available non-GLP studies: there are no GLP studies available to address this endpoint
- Historical human/control data: there are no historical data available to address this endpoint
- (Q)SAR: not considered applicable for this endpoint
- In vitro methods: not considered applicable for this endpoint
- Weight of evidence: not applicable in absence of data
- Grouping and read-across: no chemical analogues were identified
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable
- Other reasons: not applicable
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:
- None of the waivers were considered valid.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- The test is chosen taking into account that MMB is not acutely toxic to fish and no adverse effects were observed in the other ecotoxicity tests (including a daphnia repro study). MMD is biodegradable and is not likely to bioaccumulate. The concentration analyses in the daphnia reproduction test showed that MMD is stable in aqueous solution over prolonged period and therefore a semi-static set-up is concluded to be appropriate. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
- Version / remarks:
- Latest version
- GLP compliance:
- yes
Reference
Description of key information
A long term toxicity test is proposed.
Key value for chemical safety assessment
Additional information
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.
