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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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