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Toxicological information

Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure according to standard method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1991

Materials and methods

Type of study / information:
The test substance was investigated for skin irritation in 20 healthy volunteers in an 24 hour occlusive patch test at concentrations of 0.1, 1, 2, 5 and 10 % active substance.
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Duhring-Kammer-Test method
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Details on study design:
The test substance was investigated with the Duhring Kammer Test method according to the publication of Kligman and Frosch (Contact Dermatitis 5, 1979, 73 -81) for skin irritation in 20 healthy volunteers in a 24 hour occlusive patch test at concentrations of 0.1, 1, 2, 5 and 10 % active substance.
70 µL of the test substance was applied via large finn chambers (12 mm Ø) on scanpor plaster to the back of the volunteers. Irritating effects were scored 6, 24, 48 and 72 hours after removal of patches.
Reference substances were aqua demin., phys. NaCl, SDS 0.5 % a.i. and Texapone N25 1.0 % a.i.
Details on exposure:

TYPE OF EXPOSURE: Large Finn Chambers (diameter 12 mm) on Scanpor plaster were placed on the back of the panalists.

EXPOSURE LEVELS: 0.1, 1, 2, 5 and 10 % active substance; 70 µL per patch

EXPOSURE PERIOD: 24 hours

POSTEXPOSURE PERIOD: irritating effects were scored 6, 24, 48 and 72 hours after the end of exposure

DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: 20 healthy male and female volunteers (aged 19 to 57 years)

Results and discussion

Results:
Slight transient erythema was observed at concentrations of 0.1, 1 and 5 % only in 1/20 volunteers each. At a concentration of 2 % no reaction was observed. At the 10 % solution slight transient erythema was observed in 2/20 volunteers.
The test substance was considered to possess very good skin compatibility in the tested concentrations.

Applicant's summary and conclusion

Conclusions:
The test substance "partially unsaturated TEA-Esterquat" was considered to possess very good skin compatibility in all tested concentrations (0.1 - 10 % a.i).
Executive summary:

The skin irritating potential of the test substance “partially unsaturated TEA-Esterquat” was investigated with the Duhring Kammer Test method according to the publication of Kligman and Frosch (Contact Dermatitis 5, 1979, 73 -81) in 20 healthy volunteers in a 24 hour occlusive patch test at concentrations of 0.1, 1, 2, 5 and 10 % active substance.

70 µL of the test substance was applied via large finn chambers (12 mmØ) on scanpor plaster to the back of the volunteers. Irritating effects were scored 6, 24, 48 and 72 hours after removal of patches. Reference substances were aqua demin., phys. NaCl, SDS 0.5 % a.i. and Texapone N25 1.0 % a.i.

Slight transient erythema was observed at concentrations of 0.1, 1 and 5 % only in 1/20 volunteers each. At a concentration of 2 % no reaction was observed. At the 10 % solution slight transient erythema was observed in 2/20 volunteers.

 

The test substance was considered to possess very good skin compatibility in the tested concentrations.