Reaction product of 1-chloro-2,3-expoxypropane, sodium hydroxide, sodium carbonate and water

Specific investigations: other studies

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

Test material information

Constituent 1

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.