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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
Epicutaneous patch test

Test material

Constituent 1
Chemical structure
Reference substance name:
Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides
EC Number:
271-756-9
EC Name:
Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides
Cas Number:
68607-24-9
Molecular formula:
The substance is a quarternary ammonium chloride derived from fatty alcohol. The general chemical structure is R-N(Me)3+ Cl-, whereas the alkylrest R is variable for the main components C20 and C22 but also shorter and longer C-Chains (in smaller amounts)
IUPAC Name:
N,N,N-trimethyl-C20-22-(even numbered)-alkyl-1-aminium chloride

Method

Type of population:
general
Subjects:
Test type: Epicutaneous patch test with 1.0 % behentrimonium chloride in water
Subjects: Healthy male and female volunteers, age 17-80 years, nine of which with allergies, without visible skin lesions at the start of the study
Group size: 19 male and 31 female subjects
Route of exposure:
dermal
Reason of exposure:
intentional
Details on exposure:
1.0 % behentrimonium chloride in water
The test substance was applied to the skin of the back using usual test chambers. The test site was covered occlusively by adhesive plaster for 24 hours.
Examinations:
- Other: Skin reactions were evaluated 0 and 24 hours after removal of test patches.

Results and discussion

Results of examinations:
No signs of skin irritation were detected in any subject at 0 as well as at 24 hours after application.

Applicant's summary and conclusion

Conclusions:
1.0 % behentrimonium chloride in water produced no skin irritation when applied under occlusion for 24 hours in a human epicutaneous patch test.