Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

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

Constituent 1
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





Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion