Registration Dossier
Registration Dossier
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EC number: 239-590-1 | CAS number: 15541-60-3
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:
diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine
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
Available GLP studies are part of the registration dossier. None of them fulfil the requirements of a Prenatal Developmental Toxicity Study. Furthermore, the results of a literature search showed that no GLP data was available.
• available non-GLP studies
A literature search showed that there are no reliable non-GLP studies available to assess the reproductive toxicity of diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine.
• historical human data
There are no appropriate historical human data available addressing the endpoint developmental toxicity.
• (Q)SAR
There are no reliable QSAR models addressing the endpoint of developmental toxicity to the extent that is assessed in a Prenatal Developmental Toxicity Study.
• in vitro methods
No validated or regulatory accepted alternative methods are available for replacing animal testing with respect to developmental toxicity.
• weight of evidence
Considering the lack of valid, regulatory accepted in vitro methods, QSAR models and test data a weight of evidence approach is not possible.
• grouping and read-across
Possible read across analogues are 1,3,5-triazine-2,4,6-triamine phosphate (EC no. 255-449-7/CAS no. 41583-09-9) and 1,3,5-Triazine-2,4,6-triamine (EC no.203-615-4/CAS no.108-78-1).
However, the registration of 1,3,5-triazine-2,4,6-triamine phosphate relies on read across from 1,3,5-Triazine-2,4,6-triamine for the prenatal developmental toxicity endpoint.
Read across from 1,3,5-Triazine-2,4,6-triamine was considered, but the mechanism of toxicity is due to the formation of insoluble particles over time and this is dependent on the water solubility of the substance (compare the enhanced toxicity of the cyanurate analogue). For this reason, and taking into account the scarcity of developmental toxicity data for 1,3,5-triazine-2,4,6-triamine phosphates, it is proposed that a test is conducted for prenatal developmental toxicity in accordance with OECD Technical Guideline 414.
• substance-tailored exposure driven testing:
An exposure based waiving not appropriate.
• approaches in addition to above: not applicable
• other reasons: 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:
- Worker exposure to the substance will be minimized by appropriate engineering controls and risk management measures, but limited exposure may still occur as not all substance will be handled in closed systems. Waiving the OECD 414 study solely on exposure grounds is therefore not appropriate.
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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Test material
- Reference substance name:
- Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine
- EC Number:
- 239-590-1
- EC Name:
- Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine
- Cas Number:
- 15541-60-3
- Molecular formula:
- C3H6N6.xH4O7P2
- IUPAC Name:
- diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine
- Test material form:
- solid: particulate/powder
- Details on test material:
- Identification: MPP
Chemical Name: Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine
Typical batch: 31629
Typical purity: 98%
Physical State/Appearance: White powder
Expiry Date: n/a
Storage Conditions: Room temperature in the dark over silica gel
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.
