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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1972

Materials and methods

Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
Human patch test on compounded perfumes for toilet goods.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Ethical approval:
not specified
Details on study design:
TYPE OF TEST USED: Closed patch test

Vehicle used
Condition 1: Vaselinum Aldum, Unguentum Hydrophilicum
Condition 2: Unguentum Simplex, Ungeuntum Hydrophilicum

Concentrations:
Condition 1: 3 -20 %
Condition 2: 0.2-2 %

Number of subjects:
Condition 1: 1763 subjects
Condition 2: 1830 subjects
Details on exposure:
TYPE OF EXPOSURE: Closed human patch test
Condition 1: Small of back
Condition 2: Upper inside of arm

Exposure period: Condition 1: 48 hours
Condition 2: 24-72 hours

Results and discussion

Results:
The test item showed no irritation potential in the two test conditions.

Applicant's summary and conclusion

Conclusions:
In this human patch test healthy male and female subjects were tested under 2 different conditions. No irritation potential could be found in this test.
Executive summary:

In a closed human patch study the skin irritation potential of the test item was tested. 1763 healthy male and female subjects were tested in condition 1 and 1830 subjects in condition 2. The following application way was chosen: In condition 1 the site of application was the small of back in condition 2 the upper inside of arm. Vaselinum Aldum, Unguentum Hydrophilicum were used as vehicle in condition 1 and Unguentum Simplex, Unguentum Hydrophlicum were used as vehicle in condition 2. The test item was applicated in a concentration of 3 -20 % and in a concentration of 0.2 -2 %. No irritation reactions were observed in 30 subjects.