Benzenediamine, ar-methyl-, polymer with 2-methyloxirane and oxirane

Developmental toxicity / teratogenicity

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.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Oligomerisation products of o-Diaminotoluene with ethylene oxide and propylene oxide

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:

Oligomerisation products of o-Diaminotoluene with ethylene oxide and propylene oxide

Test animals

Species:

rat

Strain:

Wistar

Administration / exposure

Route of administration:

oral: gavage