Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In the only available study, the test substance dissolved in methyl ethyl ketone was assessed for its skin sensitizing potential using the Local Lymph Node Assay (LLNA) in mice.

The highest test substance concentration, which could be technically used, was 100% of the undiluted test substance. Methyl ethyl ketone was used as vehicle. To previously confirm the appropriateness of the concentrations intended for use in the main experiment, a pre-test was performed using 50 and 100% test substance concentration. During the pre-test, both animals showed signs of systemic toxicity and the animal treated with 100% undiluted test substance was found dead within one hour after the second application. Thus, a second pre-test was performed using test substance concentrations of 10 and 25% (w/v). At these concentrations the animals did not show any signs of systemic toxicity or signs of local skin irritation. Therefore, in this study, three groups each of five female mice were treated with 5, 10 or 25% (w/v) test substance concentration by topical application at the dorsum of each ear on three consecutive days.

The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. Signs of local irritation (e.g. reddening of the ear skin, ear swelling) were also not observed during the study period. A statistically significant increase in ear weights was not observed in any of the groups treated with different concentrations of the test substance in comparison to the vehicle control group.

Stimulation Indices (S.I.) of 2.21, 1.78 and 2.75 were determined with the test substance at concentrations of 5, 10 and 25% (w/v) in methyl ethyl ketone, respectively. A statistically significant increase in DPM/animal values was observed in the groups treated with 5 and 25% test substance concentration in comparison to the vehicle control group (p=0.003). However, this is not considered as biologically relevant as none of the S.I.s determined for these concentrations exceeded the threshold of 3 and as no clear dose response was observed for the tested concentrations.

The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3. The S.I. of the positive control group was 7.48.

Therefore, test substance 2,6-Xylidine did not show skin sensitizing potential in this assay under the conditions of this study.


Migrated from Short description of key information:
Skin sensitisation: LLNA; negative
Respiratory sensitisation: no data

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
Actually, there is no information available.

Justification for classification or non-classification

A classification with respect to skin sensitization is not warranted according to EU and GHS classification criteria.