1,2-Benzenediamine, ar-methyl-, reaction products with propylene oxide

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study planned

Study period:

Note: Dependent on results of first species (rat) OECD 414 developmental toxicity study, see read-across strategy and agreed testing strategy presented in Section 13

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS

DISCLAIMER:
This testing proposal is based on the knowledge at the time of the dossier update submission. In reference to the agreed testing strategy presented in Section 13 of the dossier and in line with the dossier improvement pilot project (Cefic, ECHA, 2020) bridging data are currently being generated. The registrant upholds the option to re-evaluate and refine the strategy, the best suitable test substance, order and extent of studies performed to fulfill the registration requirements, as soon as the study results become available.
A preliminary read-across justification including a matrix of the available data can be founds in Section 13 of the dossier. As soon as the results of the bridging study (OECD 422) with o-TDA-EO-PO are available, the read-across justification will be adapted.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
Same as substance being registered.

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: none available
- Available non-GLP studies: none available
- Historical human data: none available
- (Q)SAR: QSAR is not an appropriate method to address second species developmental toxicity endpoint
- In vitro methods: none available to address the information requirement for developmental toxicity in second species
- Weight of evidence: none available
- Grouping and read-across: see read-across strategy and agreed testing strategy presented in Section 13
- Substance-tailored exposure driven testing [if applicable]: technically not possible due to potential exposure to the substance
- 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:
At over 1000 tons the second species developmental toxicity study is a mandatory requirement. The substance is not classified as a Category 1 carcinogen or mutagen nor is it classified for reproductive toxicity already. In addition, although the substance has a very low order of toxicity, it is not possible to rule out the potential for systemic exposure or potential human exposure, therefore it is not possible to waive in accordance with Column 2.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
We propose to conduct an oral gavage OECD 414 in the rabbit.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,2-Diaminotoluene, propoxylated

EC Number:

918-139-9

Cas Number:

1228577-90-9

Molecular formula:

(C3H6O)n (C3H6O)n (C3H6O)n (C3H6O)n C7H10N2 sum of n: >1 - <8.5

IUPAC Name:

1,2-Diaminotoluene, propoxylated

Details on test material:

- Name of test material (as cited in study report): Tercarol 5903
- Molecular weight: Mn = 340 g/mole
- Physical state: liquid (red viscous)
- Content: > 99%
- Storage : room temperature under light protection

Specific details on test material used for the study:

Representative sample of the test substance.

Test animals

Species:

rabbit

Strain:

New Zealand White

Administration / exposure

Route of administration:

oral: gavage