1,2-Ethanediamine, 4-methylbenzenesulfonate (1:1)

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

No studies on the skin sensitising properties of ethylenediamine p-toluenesulphonate were available. However, Article 13 of REACH states that, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests, i.e. applying alternative methods such as in vitro tests, QSARs, grouping and read-across. Three studies in which the skin sensitizing potential of two constituents p-toluenesulphonate and ethylenediamine are available.

In a Local Lymph Node Assay 4 female Balb/c mice per dose were treated daily with ethylenediamine at concentrations of 1, 2.5, 5, and 10% (v/v) in acetone/olive oil (4:1 v/v) by topical application to the dorsum of each ear (left and right) for three consecutive days (DOW 2001). A control group of 4 mice was treated with the vehicle (acetone/olive oil (4:1 v/v)) only. And another control group were left untreated. Five days after the initiation exposure the mice were injected intravenously with radio labelled thymidine (3H-methyl thymidine), five hours thereafter the mice were sacrificed and the draining auricular lymph nodes were excised and pooled per group. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine. Stimulation indices (S.I.) of 1.2, 2.6, 4.9, and 8.5 were determined with the test item at concentration of 1, 2.5, 5, and 10% (v/v), respectively. Based on the S.I. determined at the 2.5 and 5% concentration, the EC3 was determined to be 2.9% (v/v). Based on the described study and under the conditions reported, it is concluded that the test substance is a skin sensitizer.

In a Guinea pig Maximization-Test Dunkin-Hartley guinea pigs were treated with ethylenediamine (Leung 1997). Twenty animals were treated with the test substance and another twenty with only the vehicle (deionized distilled water). The concentrations of the test substance used in the main study were determined by the results of the preliminary study. The intradermal induction of sensitization in the test group was performed using 5% of the test substance in both the vehicle and the Freund's Complete Adjuvant/vehicle mixture. On week later this was boosted by the topical application of the test substance at 10% concentration over the injections sties. Animals of the control group were treated in the same manner but the selected vehicle was used. Two weeks after the second induction all animals were challenged by topical application of the test substance at 5% concentration. The animals in the test group showed responses (45%). Therefore it can be concluded that the test substance showed a skin sensitising potential in guinea pigs.

In a GLP complaint sensitivity study using the Maximization-Test, performed according to OECD guideline 406, Pirbright-Hartley guinea pigs were treated with the test substance (Hoechst 1988). Ten animals were treated with the test substance and five with only the vehicle (physiological saline). The concentrations of the test substance used in the main study were determined by the results of the preliminary study. The intradermal induction of sensitization in the test group was performed using 0.2% of the test substance in both the vehicle and the Freund's Complete Adjuvant/vehicle mixture. Eight days later this was boosted by the topical application of the test substance at 20% concentration over the injections sites. Animals of the control group were treated in the same manner but the selected vehicle was used. Two weeks after the second induction all animals were challenged by topical application of the test substance at 10% concentration. The animals in the test groups showed no response (after 24 and 48 hours). Therefore it can be concluded that the test substance shows no skin sensitizing potential in guinea pigs.

Because ethylenediamine p-toluenesulphonate is a combination of the tested substances, ethylenediamine p-toluenesulphonate is considered to be skin sensitizing.

Migrated from Short description of key information:
Three studies in which the skin sensitizing potential was assessed are available, performed with two constituents of ethylenediamine p-toluenesulphonate. Ethylenediamine was tested in a Maximization-Test with guinea pigs and a Local Lymph Node Assay with mice. In both studies ethylenediamine was sentitizing to the skin. P-toluelensulphonate was tested in a Maximization-Test with guinea pigs, and was found to be non-sensitizing to the skin. Because ethylenediamine p-toluenesulphonate is a combination of the tested substances, ethylenediamine p-toluenesulphonate is considered to be skin sensitizing.

Justification for selection of skin sensitisation endpoint:
In total three studies are available with two constituents of ethylenediamine p-toluenesulphonate. Two studies show sensitising effects of ethylenediamine. The third study with p-toluenesulphonate did not show sensitising effects.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Ethylenediamine and p-toluenesulphonate are the two constituents of ethylenediamine p-toluensulphonate (1:1). Ethylenediamine is considered to be a skin sensitiser and therefore it is suspected that ethylenediamine p-toluenesulphonate is also a skin sensitizer. Therefore ethylenediamine p-toluenesulphonate is classified as Xi:R43: May cause sensitisation by skin contact in accordance with Directive 67/548/EEC (DSD) and Cat 1B:H317: May cause an allergic skin reaction in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.