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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

No data on skin sensitising properties on the substance itself are available. Therefore studies from structurally related substances are given.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Justification for type of information:
Please refer to chapter 13 for the category justification.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reading:
other: after intradermal challenge injection
Hours after challenge:
24
Group:
test chemical
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: Read-across from CAS# 8013-07-8
Reading:
other: after occlusive epicutanous application
Hours after challenge:
24
Group:
test chemical
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Read-across from CAS# 8013-07-8
Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No information is available for the substance itself, therefore information is derived from the structural analogue CAS# 158318-67-3, CAS# 8013-07-8 and CAS# 61789-01-3, for which data from guinea pig maximisation test, Buehler assays are available.

Buehler test

A GLP guideline study according to OECD TG 406 was performed with Pirbright White guinea pigs (10 animals per dose group) to assess the skin sensitising potential of the test substance (Henkel, 1993). After a weekly epidermal induction (0.5 mL of a 25% test substance solution), which was performed thrice, a epidermal challenge procedure was performed with 10% test substance solution, which was supposed to be a non-irritating concentration regarding the results obtained from the dose finding study, which was performed prior to the main study. While 10/10 animals of the negative control group showed a slight reaction, 8/10 animals of the test group showed a slight reaction after 24 h of the challenge procedure. These findings were also present after 48 h, when 10/10 control animals and 5/10 test animals still showed a slight reaction to the challenge. Because of the high number of positive responses in the control group, the data are judged to be inconclusive and insufficient for classification purposes (Henkel 1993).

Guinea pig maximisation test (CAS# 8013-07-8)

The contact sensitizing potential of the test item was assessed in vivo using an guinea pig maximisation test. The study was performed according to the optimization test by Maurer et al (1975, 1980) (similar to OECD 406, no GLP). The test was performed on groups of 10 male and 10 female guinea pigs of the Pirbright White Strain. The animals were treated with 0.1ml of 0.1% solution of the test substance. Under the experimental conditions employed, no differences between the test group and the vehicle-treated controls were seen. After either intradermal or epidermal challenge application of the test substance.

The test substance was found to be devoid of skin-sensitising (contact allergenic) potential in albino guinea pigs.

CAS# 61789 -01 -3

Sensitization of 20 male albino guinea pigs was evaluated by 8 intracutaneous injections (three per week on alternate days) and topical applications of a 0.1% solution of the test substance during 2 1/2 weeks.

A three-week incubation period was followed by a challenge dose. 24 and 48 hours later the examination for possible sensitization reactions was made.

The animals showed no sensitization upon the test material.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No effects were observed in the skin sensitization tests. Therefore, the substance does not require classification as a skin sensitizer under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.