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Toxicological information

Specific investigations: other studies

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Administrative data

Endpoint:
specific investigations: other studies
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
Not specified.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Various test materials, 0.05 ml/patch, were applied to the back of 50 healthy Japanese male adults for 48 hours. Thirty minutes later irritation of the skin at the application site was evaluated.
GLP compliance:
not specified
Type of method:
in vivo
Endpoint addressed:
skin irritation / corrosion

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
Glycerin was obtained from Wako Junyaku. No further details were provided.

Test animals

Species:
human
Strain:
other: Japanese males
Sex:
male
Details on test animals and environmental conditions:
Healthy Japanese male adults were used.

Administration / exposure

Route of administration:
dermal
Vehicle:
water
Remarks:
50:50 (w:w)
Details on exposure:
The amount of substance applied was 0.05 ml/patch. Patches were 15 mm square.
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No additional information available
Duration of treatment / exposure:
48 hours
Frequency of treatment:
A single treatment
Post exposure period:
humans were examined 30 minutes after removing the patch
No. of animals per sex per dose:
50 humans were used although Table in publication states 34 subjects were used.
Details on study design:
No additional details available.

Examinations

Examinations:
Humans were evaluated 30 minutes after removing the patch and the level of irritation recorded.
Positive control:
Not applicable

Results and discussion

Details on results:
Based on a bar graph, 35% of the subjects examined had some degree of erythema. Approximately 30% of the total subjects had questionable erythema with the remainder (about 3% of the total subjects) being definite erythema.

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Conclusions:
In a 48 hour patch test with 50 individuals, only one or two individuals had definite irritation. Approximately 30% had questionable irritation and the remainder showed no irritation.
Executive summary:

A human patch test of glycerine was conducted with 50 healthy Japanese males. Approximately 0.05 ml of a 50:50 (w:w) solution was applied to the upper back for 48 hours. At the end of the 48 -application period, the patch was removed and the test site examined 30 minutes later. In a 48 hour patch test with 50 individuals, approximately 3% had definite irritation. Approximately 30% had questionable irritation and the remainder showed no irritation.