Registration Dossier
Registration Dossier
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EC number: 237-572-8 | CAS number: 13845-18-6
Endpoint summary
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:
In order to assess the cutaneous allergenic potential of Sodium Sulphamate the Maximization-Test was performed in 15 (10 test and 5 control) male albino Dunkin Hartley guinea pigs, in accordance with OECD Guideline No. 406 and theCommission Regulation (EC) No 440/2008, B.6.
The intradermal induction of sensitisation in the test group was performed in the nuchal region with a 5% dilution of the test item in purified water and in an emulsion of Freund's Complete Adjuvant (FCA)/physiological saline. The epidermal induction of sensitisation was conducted for 48 hours under occlusion with the test item at 50% in purified water one week after the intradermal induction. The animals of the control group were intradermally induced with purified water and FCA/physiological saline and epidermally induced with purified water under occlusion.
Two weeks after epidermal induction the test and control animals were challenged by epidermal application of the test item at 25% in purified water and purified water alone under occlusive dressing.
Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.
Results - Skin Reactions after the Challenge Procedure
After 24 hours
Positive/Total
% Positive of Total
After 48 hours
Positive/Total
% Positive of Total
Control Group
Sodium Sulphamate, 25% in purified water (left flank)
0/5
0%
0/5
0%
Purified water only (right flank)
0/5
0%
0/5
0%
Test Group
Sodium Sulphamate, 25% in purified water (left flank)
0/10
0%
0/10
0%
Purified water only (right flank)
0/10
0%
0/10
0%
No intercurrent deaths occurred during the course of the study.
No toxic signs were evident in the guinea pigs of the control or test group.
No local skin effects were observed in the guinea pigs of the control or test group.
Based on the findings in an adjuvant sensitisation test (M&K-test) in guinea pigs and in accordance to Regulation (EC) No 1272/2008, Sodium Sulphamate does not have to be classified and labeled as a skin sensitizer.
Migrated from Short description of key information:
Based on the findings in an adjuvant sensitisation test (M&K-test) in guinea pigs Sodium Sulphamate does not have to be classified and labeled as a skin sensitizer.
Justification for classification or non-classification
Based on the findings in an adjuvant sensitisation test (M&K-test) in guinea pigs and in accordance to Regulation (EC) No 1272/2008, Sodium Sulphamate does not have to be classified and labeled as a skin sensitizer.
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