Registration Dossier
Registration Dossier
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EC number: 500-303-2 | CAS number: 115340-85-7 1 - 4.5 moles ethoxylated
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study planned
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
[Please provide information for all of the points below. The information should be specific to the endpoint for which testing is proposed. Note that for testing proposals addressing testing on vertebrate animals under the REACH Regulation this document will be published on the ECHA website along with the third party consultation on the testing proposal(s).]
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : 4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco
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 : In vitro mammamlian cell micronucleus study is ambiguous
- Available non-GLP studies : Not available
- Historical human data : Not available
- (Q)SAR : Not available
- In vitro methods : The conducted in vitro mammamlian cell micronucleus study is ambiguous: According to REACH Annex VIII no. 8.4.4 column 2 an appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the genotoxicity studies in Annex VII or VIII.
- Weight of evidence : Not available
- Grouping and read-across: Not available
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:
The conducted in vitro mammalian cell micronucleus study is ambiguous: According to REACH Annex VIII no. 8.4.4 column 2 an appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the genotoxicity studies in Annex VII or VIII.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]
Data source
Materials and methods
Test guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Test material
- Reference substance name:
- 4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco
- EC Number:
- 500-303-2
- EC Name:
- 4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco
- Cas Number:
- 115340-85-7
- IUPAC Name:
- 4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco
- Test material form:
- liquid
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.
