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Administrative data

Description of key information

No sensitizing potential expected.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is a strong acid (pH ≤2.0) or base (pH =>11.5)
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Data obtained by Read-Across from ε-Caprolactam:

epsilon-Caprolactam was tested according to EPA-guidelines in a guinea pig maximisation test (challenge: 75% caprolactam in water) and in a modified Buehler test (challenge: 25% caprolactam in water) and was considered to be not sensitizing. (Springborn Lab., 1991).

In the Buehler test a minimal dermal reaction (grades 0 to marginal) was observed in both test and negative control animals after the challenge, as well as after the rechallenge. Mean dermal scores were comparable between both groups. Ambiguous result: in test group 18/20 (24h) and 4/20 (48h) as well as in controls 8/10 (24h) and 2/10 (48h). In rechallenge also only ambiguous results were

found 11/20 (24h) and 5/20 (48h) in test groups and in control 8/10 (24h) and 5/10 (48h). The skin effects observed in the control animals after the challenge are an indication of an irritation reaction to the test concentration used. The use of the data for determining skin sensitization potential is limited by the use of an irritating concentration for the challenge treatment. However, caprolactam

was not considered to be a contact sensitizer under the test conditions chosen.

Following challenge with epsilon-Caprolactam in the maximisation test, dermal responses in the test group consisted of grade ± reactions (13/20) and grade 1 reactions (7/20). Slight edema were also observed at 7/20 test sites at the 24 hours interval. By 48 hours, a grade 1 reaction was noted in 1/20 test animals. Dermal responses in control group animals consisted of a grade 1 reaction (with slight edema) in 1/5 animals at 24 hours and of grade + to 0 reaction at all other control sites during the scoring intervals. The skin effects in the control group animals after challenge treatment are an indication of an irritation reaction to the test concentration used. In conclusion, the use of the data for determining based on the concurrent reaction in the control animals and the decrease in the

reaction after 24 to 48 hours, caprolactam is not considered to be a contact sensitizer under the test conditions chosen.

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Data obtained by Read-Across from sodium hydroxide:

Data on skin sensitisation were reported by Park et al. (1995). Male volunteers were exposed on the back to sodium hydroxide concentrations of 0.063 – 1.0 % (induction). After 7 days the volunteers were challenged to a concentration of 0.125 %. The irritant response correlated well with the concentration of NaOH, but an increased response was not observed when the previously patch

tested sites were rechallenged. Based on this study sodium hydroxide has no skin sensitisation potential. Furthermore NaOH has been used widely and for a long time and no human cases of skin sensitisation have been reported and therefore NaOH is not considered to be a skin sensitizer.

Justification for selection of skin sensitisation endpoint:
Since sodium caprolactamate hydrolyses under physiological conditions with the formation of epsilon-Caprolactam and sodium hydroxide, read-across from toxicological studies of epsilon-Caprolactam is justified. The corresponding endpoint selection refers to the most meaningful study. Additionally, there is no indication of any allergic action derived from sodium hydroxide.

A study with the substance itself does also not need to be conducted because of its pH value.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

There is no indication of any allergic action, therfore is no need for classification.