2-Propenenitrile, reaction products with ethylenediamine, hydrogenated

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Additional information:

Skin Sensitisation:

Only one Buehler Test of validity 1 (BASFSE.32H0402/042325) is available, which was conducted with a surrogate of the registered substance, N,N'-bis(3-aminopropyl)ethylenediamine (CAS No. 10563-26-5).

 

The surrogate test substance was tested positive in the Buehler Test, conducted according to the OECD Guideline 406 (Skin Sensitization) in guinea pigs (Hartley). The test-substance concentrations for the main test were selected based on the results of a pretest. All inductions were performed with a 10% test-substance preparation in doubly distilled water and for the challenge a 5% test-substance preparation in doubly distilled water was chosen. 1 control group and 1 test group were used. The inductions were performed on days 0, 7 and 14, and a challenge was carried out 14 days after the last induction.

The inductions caused discrete or patchy to intense erythema, swelling and eczematous skin changes in all test group animals. For the 3rd induction the test patch was moved to the middle of the flank in one test group animal because of severe skin irritation effect. After the challenge discrete or patchy to moderate and confluent erythema was observed in the test group animals 24 and 48 hours after removal of the patches. Whereas no animal showed positive reaction 24, and 48 hours after challenge in the negative control group, 12/10 after 24 hours and 16/20 animals after 48 hours (for a total of 16/20 animals) showed a positive reaction after challenge treatment.

Based on the results of this study and applying the evaluation criteria for a Buehler test, it was concluded that N,N'-bis(3-aminopropyl)ethylenediamine has a sensitizing effect on the skin of the guinea pig in the Buehler Test under the test conditions chosen.

Migrated from Short description of key information:
No skin sensitisation studies of registered substance were available. The registered substance is a complex reaction mixture, containing N,N'-bis(3-aminopropyl)ethylenediamine (CAS No. 10563-26-5) and N-(2-aminoethyl)-1,3-propanediamine (CAS No. 13531-52-7) among others as majors components. One of these two components were used as surrogate to evaluate the skin sensitisation potential of the registered substance. For read across justification please refer to IUCLID chapter 13.

Respiratory sensitisation

Endpoint conclusion

Additional information:

Respiratory sensitisation:

There are no data available for N3/N4-amine. However, the mixture will be classified and labeled as a respiratory sensitiser due to the presence of ethanediamine (CAS No. 107-15-3) as a secondary constituent.

Migrated from Short description of key information:
No data

Justification for classification or non-classification

Based on the above described studies and considering the worst case assumption that the test substance contains 100% of its most toxic surrogate the test substance could be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 as follows:

skin sensitising (GHS cat. 1)

Moreover, the mixture will be classified and labeled as respiratory sensitising (GHS cat. 1) due to the presence of ethanediamine (CAS No. 107-15-3) as a secondary constituent.