Registration Dossier
Registration Dossier
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EC number: 257-913-4 | CAS number: 52434-90-9
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: AP 729; 1,3,5-tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione.
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: No studies conducted according to OECD 414 are available for the considered substance.
- Available non-GLP studies: There are no non-GLP developmental toxicity studies available for the considered substance.
- Historical human/control data: No human data exist on AP 729.
- (Q)SAR: At our current knowledge, we are not aware of recognised validated (Q)SAR methods adequately covering all the key aspects of this endpoint and resulting in a reliable prediction of developmental toxicity.
- In vitro methods: Three in vitro embryotoxicity tests to predict developmental toxicity have been validated but have not been accepted for regulatory use; moreover, these tests showed high predictivity only for strongly embryotoxicity chemicals [Ref: “Chapter R.7a: Endpoint specific guidance” Version 6.0. June 2017. ECHA]. Based on the absence of toxic effects in the conducted Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD TG 422), embryotoxic effects are not expected for the considered substance.
- Weight of evidence: We do not consider that the available information is adequate to characterise the endpoint with a weight of evidence approach.
- Grouping and read-across: At our current knowledge, we are not aware of possible grouping or read-across evidences.
- Substance-tailored exposure driven testing: The percentage of substance AP 729 within the polymers is typically low and once it is incorporated within the matrix in the form of an article it is unavailable for exposure.
- Approaches in addition to above [if applicable]: Not applicable.
- Other reasons [if applicable]: None identified.
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:
- A prenatal developmental toxicity study on one species (rat or rabbit) is a standard information requirement under Annex IX of Reach Regulation. Annex IX, section 8.7.2., column 2, applies to an additional pre-natal developmental toxicity study in a second species, that is the other preferred species to the one used in the first study, which shall be proposed by the registrant or may be required by the Agency if there is a concern for developmental toxicity based on the outcome of the first study and all other relevant data.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design/methodology proposed: The proposed pre-natal developmental toxicity testing on rat would be performed according to OECD Guideline 414, as adopted on 25 June 2018, with oral administration of the test substance. We propose the present study to be performed via oral route, since it would increase the bioavailability of the test substance and because OECD 414 is specifically designed to administer chemicals through intubation. Moreover, rat is proposed as preferred species since, according to OECD TG 414 adopted on 25 June 2018, additional endocrine disrupter relevant endpoints are rat-specific requirements.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Test material
- Reference substance name:
- 1,3,5-tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- EC Number:
- 257-913-4
- EC Name:
- 1,3,5-tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- Cas Number:
- 52434-90-9
- Molecular formula:
- C12H15Br6N3O3
- IUPAC Name:
- tris(2,3-dibromopropyl)-1,3,5-triazinane-2,4,6-trione
- Reference substance name:
- unknown impurities
- IUPAC Name:
- unknown impurities
- Test material form:
- solid: particulate/powder
Constituent 1
impurity 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.
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