Registration Dossier

Diss Factsheets

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:

Since available information from skin/eye irritation/corrosion testing indicates that the test substance is corrosive, no additional tests on skin sensitization are necessary according to REACH regulation (Annex XI). 2 available tests (Hoechst-Calenese Corp., 1987, Val2; and Eastman Kodak Co., 1955, Val4) indicate however that the test substance in a negative sensitizer.


In the Hoechst-Calenese Corp. Mouse ear swelling test (MEST) study, conducted generally based on "Development and Validation of an Alternative Dermal Sensitization Test: Mouse Ear Swelling Test" (MEST; by Gad SC, Dunn BJ and Dobbs DW, in Toxicol. & Appl. Parmacol., 84: 93-114; 1986), 1.0% test substance at induction (maximum non-irritating concentration; 100 µl applied to the abdomen) and 50.0% at challenge/rechallenge (maximum non-corrosive concentration; 10 µl applied to the ear, left at challenge or right ear at re-challenge) were administered to each 10 female albino CF-1 (BR) mice. The study include 3 groups of each 5 animals for challenge irritation contol (2, test substance and positive control substance) and rechallenge irritation control and 10 animals for the positive control substance (2,4-dinitrochlorobenzene 0.5% at induction, 1.0% at challenge). 70% ethanol was used as vehicle for both the test substance and the positive control substance. 24 and 48 hours after challenge/re-challenge administration, the test animals were lightly anesthetized with ether and the ear thickness was measured and recorded, for both ears.


1/10 animals (10%) challenged with test substance exhibited a positive response at 24 hours only. However, 1/5 challenge irritation control animals also exhibited a positive response (test ear 135% thicker than control ear, necrosis present). 1/10 animal rechallenged with test substance exhibited a positive response at 24 hours and 1/10 animal exhibited a positive response at 48 hours. But, one animal in the rechallenge irritation control group exhibited a positive response at 24 hours (test ear 84% thicker than control ear, foci of necrosis present), and 1 animal exhibited a positive response at 48 hours.

In the positive control group, 60% of the animals exhibited a positive sensitization response at 24 hours (test ear at least 20% thicker than control ear) and 50% exhibited a positive response at 48 hours. There were no positive responders in the irritation control group. This positive response to a known sensitizer demonstrated the susceptibility of this group of animals to sensitization.

Migrated from Short description of key information:
Skin sensitisation: not sensitizing
Respiratory sensitisation: no data available.

Justification for classification or non-classification

- Skin sensitization

Based on the results of the Hoechst-Calenese Corp. study discussed above, the responses of negative control and treated animals were comparable in MEST and probably due to irritation; no sensitization was apparent. The test substance should therefore not be classified for skin sensitization.

- Respiratory sensitisation

no data available