2,2,6,6-tetramethylpiperidin-4-ol

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

There was one report from a study on skin sensitization in guinea pigs according to the method described by Magnusson and Kligman (Ciba GmbH Lampertheim, 1993). This study was identified as the key study because it was well conducted and used a current protocol [OECD TG 406]. In this in vivo study, 30 female and male guinea pigs were used (10 male and 10 female animals as test group, and 5 male and 5 female animals served as control group). During the induction procedure the test group was exposed to 1 % 2,2,6,6 -tetramethylpiperidin-4 -ol via intradermal injection and 50 % 2,2,6,6 -tetramethylpiperidin-4 -ol via topical application. The control group was exposed to vehicle only during this procedure. All animals were challenged with 30% 2,2,6,6 -tetramethylpiperidin-4 -ol and vehicle and all animals were rechallenged with 10% of the test substance and vehicle. At challenge, 9/16 (56%) positive responses were noted in the test group after 24 and 48 h and 7/10 (70%) positive response was noted in the control group following treatment with 50% 2,2,6,6 -tetramethylpiperidin-4 -ol after 24 and 48 h. At rechallenge, 5/16 (31%) and 11/16 (69%) positive responses were noted in the test group and 0/10 positive responses were noted in the control group following treatment with 10% 2,2,6,6 -tetramethylpiperidin-4 -ol after 24h and 48h.

In all animals of the test group clinical symptoms (hunched posture, piloerection, and sedation) were observed. Since initially symptoms were observed in all animals of the test group and with respect to the mortality recorded (two animals moribund, two animals found dead) treatment-relation cannot be fully excluded.

Conclusion: 2,2,6,6 -tetramethylpiperidin-4 -ol showed a moderate to strong grade of skin-sensitising (contact allergenic) potential

according to the grading of Magnusson and Kligman in albino guinea pigs.

Migrated from Short description of key information:
sensitising, CIBA,1993, GLP-OECD Guideline study

Respiratory sensitisation

Endpoint conclusion

Additional information:

Actually no data available.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

Skin sensitisation:

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. As moderate to strong grade of skin-sensitising potential according to the grading of Magnussion and Kligman were observed, 2,2,6,6 -tetramethylpiperidin-4 -ol has to be classified as Category 1 A (H317).

Respiratory sensitisation

Actually, there are no data available for a classification regarding to this endpoint.