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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Constituent 1
Chemical structure
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

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