Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
after approval by ECHA; within 2 years, see read-across strategy and agreed testing strategy presented in Section 13
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:
1,2-Diaminotoluene, ethoxylated and propoxylated
CAS number 67800-94-6
EC number 614-144-2


CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies: There are no GLP studies available covering pre-natal developmental toxicity study information requirements.
- Available non-GLP studies: There are no non-GLP studies available covering pre-natal developmental toxicity information requirements.
- Historical human data: There are no historical human data available on pre-natal developmental toxicity study for the substance.
- (Q)SAR: At present there is no valid (Q)SAR model available to address pre-natal developmental toxicity (ECHA Guidance in Information Requirements and Chemical Safety Assessment Chapter R 7a: Endpoint specific guidance).
- In vitro methods: At present there are no valid in vitro methods available to address pre-natal developmental toxicity. (ECHA Guidance in Information Requirements and Chemical Safety Assessment Chapter R 7a: Endpoint specific guidance).
- Weight of evidence: There are no data available which are sufficient for weight of evidence approach.
- Grouping and read-across: Presently there are no substances or a category of substances known which apply for read across addressing the endpoint of pre-natal developmental toxicity.
- Substance-tailored exposure driven testing: not applicable
- 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:
In accordance to Annex X, Section 8.7.2 of the REACH Regulation and the Commission Regulation (EU) 2015/282 (amending Annexes VIII, IX and X to Regulation (EC) No 1907), the pre-natal developmental toxicity study (OECD 414) in the first species (here: rat), is the standard information requirement for toxicity to development for substances manufactured and imported in quantities of 1000 tpa or more.
No options for waiving according to column 2, are possible.


FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
Study design: An OECD 414 guideline study in the rat with oral exposure via gavage is proposed.

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:
3-methylbenzene-1,2-diamine; 2-methyloxirane; oxirane
EC Number:
614-144-2
Cas Number:
67800-94-6
Molecular formula:
C7 H10 N2. ( C3 H6 O )x.(C2 H4 O)y ; 1 < x + y < 8.5
IUPAC Name:
3-methylbenzene-1,2-diamine; 2-methyloxirane; oxirane

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Applicant's summary and conclusion