Registration Dossier
Registration Dossier
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EC number: 200-882-9 | CAS number: 75-59-2
Long-term toxicity to fish
Administrative data
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- experimental study planned
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Tetramethylammonium hydroxide (TMAH) / EC 200-882-9 / CAS 75-59-2
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: none available
- Available non-GLP studies: none available
- Historical human/control data: not applicable
- (Q)SAR: none available
- In vitro methods: none available
- Weight of evidence: none available
- Grouping and read-across: not applicable
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: 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:
- According to data point 9.1.6 and taking into account the Board of Appeal Decision in case A-011-208, data on the long-term toxicity to fish is a standard data requirement which cannot be waived and thus should be submitted. Since this information was not already provided as part of Annex VIII requirements, the data needs to be generated and submitted for the current REACH Registration above 1000 tonnes (Annex X).
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- The study will be performed according to OECD TG 210 (2013, the most recent version available) and GLP principles.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
- Version / remarks:
- 2013
Test material
- Reference substance name:
- Tetramethylammonium hydroxide
- EC Number:
- 200-882-9
- EC Name:
- Tetramethylammonium hydroxide
- Cas Number:
- 75-59-2
- Molecular formula:
- C4H12N.HO
- IUPAC Name:
- N,N,N-trimethylmethanaminium hydroxide
Constituent 1
Results and discussion
Applicant's summary and conclusion
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.
