Registration Dossier
Registration Dossier
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EC number: 249-171-5 | CAS number: 28706-25-4
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned
- Study period:
- not yet defined
- 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: tetrasodium 4-hydroxy-7-
[({5-hydroxy-7-sulfonato-6-[(6-sulfonato-2-naphthyl)diazenyl]-2-naphthyl}carbamoyl)amino]-3-[(6-
sulfonato-2-naphthyl)diazenyl]naphthalene-2-sulfonate
-EC: 249-171-5
-CAS: 28706-25-4
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies: OECD 414 Not Available
- Available non-GLP studies: Not Available
- Historical human data: Not Available
- (Q)SAR: Not Available
- In vitro methods: Not Available
- Weight of evidence: Not Available
- Grouping and read-across: no read across data available for finalisation of the endpoint
- Substance-tailored exposure driven testing [if applicable]: not applicable
- Approaches in addition to above [if applicable] : not applicable
- Other reasons [if applicable]: 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:
-No studies on the substance itself or on identified analogue substances have been gathered as to fulfill the information requirements for the pre-natal developmental toxicity study as requested in Annex IX under the REACh Regulation and subsequent updates. OECD 414 is a standard information requirement for Annex IX substance and a testing proposal is submitted.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: The study is performed initially only on one specie, rats
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(6-sulphonato-2-naphthyl)azo]naphthalene-2-sulphonate]
- EC Number:
- 249-171-5
- EC Name:
- Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(6-sulphonato-2-naphthyl)azo]naphthalene-2-sulphonate]
- Cas Number:
- 28706-25-4
- Molecular formula:
- C41H28N6O15S4.4Na
- IUPAC Name:
- tetrasodium 4-hydroxy-7-[({5-hydroxy-7-sulfonato-6-[(6-sulfonato-2-naphthyl)diazenyl]-2-naphthyl}carbamoyl)amino]-3-[(6-sulfonato-2-naphthyl)diazenyl]naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: gavage
Results and discussion
Results (fetuses)
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
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.
