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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
Reference substance name:
Glycerol
EC Number:
200-289-5
EC Name:
Glycerol
Cas Number:
56-81-5
Molecular formula:
C3H8O3
IUPAC Name:
glycerol
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 or test system 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.