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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 the 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 the 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 panelists were exposed to 1 to 10 % solutions of the 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 panelists. 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 the partially unsaturated TEA-Esterquat, revealed no evidence of a skin irritation response in humans. (However, a quickly disappearing slight erythema was observed in two panelists.)

Human open application tests, reflecting more realistically the type of exposure humans are experiencing when using the 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 the partially unsaturated TEA-Esterquats in concentrations up to 10 % resulted in only mild and transient skin irritation, in some of the panelists.

 

Sensitisation

In a dermal sensitisation study, according to the publication of Stotts 1980, (Current Concepts in Cutaneous Toxicity Academic Press pp. 41-53) with the fully saturated TEA-Esterquat ( 2 % aqueous dilution), a total of 105 healthy volunteers were tested using the Human Repeated Patch Test method (HRIPT). 105 volunteers took part in the study and were exposed to 9 induction patches containing 0.4 mL of the aqueous dilution of the test substance under occlusive dressing during a three week period.On study day 36 challenge patches were applied to both arms of each subject. 7 volunteers dropped out, 5 due to personal reason and 2 volunteers due to a serious adverse event (broken wrist and whiplash injury). Neither serious adverse event was considered to be an adverse reaction to treatment.

One non-serious adverse event was recorded, (abscess on the gum) which was not considered to an adverse reaction to treatment. 

During induction the majority of subjects (53%) showed no visible response to the test substance, but mild irritancy was seen in 46% of subjects on at least one day during induction. One subject showed a moderate irritation response on Day 12 but this had resolved by Day 15 following patch relocation. Even under the slight irritant test conditions there was no evidence of sensitisation at challenge in any subject.

In a dermal sensitisation study, according to the publication of Stotts 1980, (Current Concepts in Cutaneous Toxicity Academic Press pp. 41-53) with the fully saturated TEA-Esterquat ( 0.5, 1, and 2 % aqueous dilution), a total of 103 healthy volunteers were tested using the Human Repeated Patch Test method (HRIPT).103 volunteers took part in the study and were exposed to 9 induction patches containing 0.4 mL of the aqueous dilutions (water, 0.5, 1 and 2 % test substance) under occlusive dressing during a three week period. On study day 36 challenge patches (1 % test article concentration) were applied to both arms of each subject. 15 volunteers dropped out, two forgot to attend; one due to work commitments; five due to personal reasons; five due to personal illness and one due to an adverse event (Chicken pox) which was not product related and one due to protocol violation. At 2 % w/v active substance, minimal irritation was observed. Based on this, the subjects were challenged at 1 % w/v active substance and distilled water and the results indicate that no questionable reactions were observed to the 1 % w/v active substance. There was no evidence of sensitisation to the test substance in any panelist during induction or challenge.

Taken together, 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 the fully saturated TEA-Esterquat was considered to induce a skin sensitisation response in humans.