Registration Dossier
Registration Dossier
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EC number: 500-655-7 | CAS number: 161308-15-2
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned
- 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: 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with biphenyl-4-ol
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: Existing data does not address the endpoint, see attached Testing Proposal for details.
- Available non-GLP studies: Existing data does not address the endpoint, see attached Testing Proposal for details.
- Historical human data: Existing data does not address the endpoint, see attached Testing Proposal for details.
- (Q)SAR: The available (Q)SAR methods are currently not sufficient to address the complex endpoints
for reproductive and/or development toxicity, see attached Testing Proposal for details.
- In vitro methods: The available in vitro methods are currently not sufficient to address the complex endpoints for reproductive and/or development toxicity, see attached Testing Proposal for details.
- Weight of evidence: There is insufficient weight of evidence from several independent sources to address the endpoint, see attached Testing Proposal for details.
- Grouping and read-across: It is not possible to address this endpoint with grouping of substances and read-across approaches; see attached Testing Proposal for details.
- Substance-tailored exposure driven testing: A REACH Annex XI adaptation based on exposure considerations is not applicable, see attached Testing Proposal for details.
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:
- No, 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; see attached Testing Proposal for details.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- The most appropriate study is the OECD Guideline for Testing of Chemicals No. 414: Prenatal Developmental Toxicity Study which is replicated in Council Regulation (EC) No 440/208 test method B.31; see attached Testing Proposal for details.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Test material
- Reference substance name:
- BM1-resin
- IUPAC Name:
- BM1-resin
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identity : BM1-resin
Lot number / Batch number: 5003-2
Expiry : January 1996
Composition: > 98 % Epoxide resin based on Bisphenol A and epichlorohydrin, blocked with paraphenyl phenol
Appearance: Yellowish powder
Storage conditions: Room temperature
Date received: 9 June 1994
Constituent 1
Test animals
- Species:
- rat
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.
