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Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
7 September 1994 - 9 September 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted after approval of the protocol and Informed Consents by the Institutional Review Board

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Type of study / information:
Glycerine USP was evalauted for primary irritation potential in humans
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Test material was applied to the skin of 33 humans for 24 hours and the response to the test material was observed.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Glycerine USP
- Substance type: not specified in the report
- Physical state: not specified in the report
- Analytical purity: not specified in the report
- Impurities (identity and concentrations): not specified in the report
- Composition of test material, percentage of components:not specified in the report
- Isomers composition: not specified in the report
- Purity test date: not specified in the report
- Lot/batch No.: not specified in the report
- Expiration date of the lot/batch: not specified in the report
- Stability under test conditions: not specified in the report
- Storage condition of test material: not specified in the report

Method

Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
Eight test articles in addition to a positive control (0.5% sodium lauryl sulfate in distilled water) and the negative irritant controls (distilled water and mineral oil USP) were tested simultaneously. The test articles (0.2 ml) were applied to a non woven cotton pad (Webril) which was held securely on two opposing sides by a strip of hypoallergenic tape. Glycerine was tested as a 25% solution in mineral oil.

A one application, 24-hour semi-occluded patch study was conducted to compare the skin irritancy potential of the test articles. Negative controls of distilled water and mineral oil USP and a positive control of 0.5% sodium lauryl sulfate were also tested.

Thirty female subjects and 3 male subjects entered and completed the study.
Exposure assessment:
measured
Details on exposure:
Test material was applied to the paraspinal region of the back. 0.2 ml was applied on the patch pad which was attached to the skin. Exposure was semi-occluded.

Results and discussion

Results:
No reactions were seen in the test subjects where glycerin or the vehicle, mineral oil was applied.

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Conclusions:
Under the conditions of the study, Glycerine USP (25% concentration) exhibited no clinical irritation when tested in humans.
Executive summary:

The dermal irritation potential was examined in 33 humans, 30 female and 3 male. Under the conditions of the study, Glycerine USP (25% concentration) exhibited no clinical irritation when tested in humans.