Registration Dossier
Registration Dossier
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EC number: 931-203-0 | CAS number: 1335202-88-4
Endpoint summary
Administrative data
Description of key information
Human data from two different types of skin irritating test methods (24 hour occlusive application and 30 minute open application) are available for
partially unsaturated TEA-Esterquat, including the results from a total of 100 volunteers.
Information from two Human Repeated Insult Patch Tests evaluating the skin sensitisation of TEA-Esterquats is available. There was no evidence
for a skin sensitisation potential from this studies involving a total of 208 volunteers.
Additional information
Skin irritation
In three studies, a total of 60 panellists were exposed to 1 to 10 % solutions of partially unsaturated TEA-Esterquat for 24 hours under occlusive conditions. Slight and transient irritation indicated by the occurrence of erythema was observed in 5 of 60 panellists. In one of the studies applying a 5 % test substance dilution a skin irritation comparable to the water control was observed. Most likely this is the result of the extended 24-hour exposure and occlusive conditions.
Two 30-minute open application studies conducted with a total of 40 volunteers, which were exposed to 10 % aqueous solutions of partially unsaturated TEA-Esterquat, revealed no evidence of a skin irritation response in humans. (However, a quickly disappearing slight erythema was observed in two panellists.)
Conclusion
Human open application tests, reflecting more realistically the type of exposure humans are experiencing when using partially unsaturated TEA-Esterquat, showed a very favorable skin compatibility profile indicated by an absence of a skin irritation response. Even under more severe exposure conditions such as 24-hrs occluded patch tests, the exposure to partially unsaturated TEA-Esterquats in concentrations up to 10 % resulted in only mild and transient skin irritation, in some of thepanellists.
Sensitisation
The human volunteer studies were conducted in line with the respective and broadly accepted testing protocol according to the method of Stotts (1980) under the supervision of expert dermatologists.
None of the 2 studies involving exposures of a total of 208 human volunteers to fully saturated TEA-Esterquat was considered to induce a skin sensitisation response in humans.
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