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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Information from peer reviewed reference with sufficient details for scientific evaluation

Data source

Reference
Reference Type:
publication
Title:
Interspecies Comparisons of Skin Irritancy
Author:
Nixon G, Tyson C & Wertz W
Year:
1975
Bibliographic source:
Toxicology and Applied Pharmacology 31, 481-490 (1975)

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
This test followed the revised Federal Hazardous Substances Act (FHSA) procedure that had been proposed by the FDA (Edwards, 1972), with a 4-hour rather than 24-hour exposure.
GLP compliance:
no
Remarks:
Not applicable to human studies

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Isopropyl alcohol

Method

Type of population:
not specified
Subjects:
No details provided
Ethical approval:
not specified
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
not specified
Details on exposure:
Each subject afforded 8 test sites about 4 cm square, aligned 4 on each side of the back about 5 cm from the midline. Sites were vertically spaced 3 cm apart in the area between the scapula and the waist. When testing was done on both intact and abraded sites, 4 materials were tested on each subject. To reduce discomfort from irritating substances, abrasions were made in a single criss-cross design, rather than in the tic-tac-toe pattern specified for the rabbit test. Materials were tested on both abraded and intact sites of human volunteers whenever appropriate. Materials that were known or suspected to be corrosive or severely irritating were either not applied to humans or were not tested on abraded sites.
Examinations:
- Other: skin irritation/corrosion
Medical treatment:
Most subjects were reexamined after one month to see whether any delayed reactions had occurred. Humans who had shown evidence of severe reactions were followed for as long as necessary to determine whether permanent damage had occurred.

Results and discussion

Clinical signs:
Not reported.
Results of examinations:
See results below.
Effectivity of medical treatment:
Not applicable
Outcome of incidence:
Not applicable

Any other information on results incl. tables

The mean scores for irritant response of intact and abraded human skin were 0.0 (negligible) and 0.8 (slight), respectively. The Primary Irritation Index (PII) was 0.4, and the tissue destruction fraction was 0/6, whether the skin was intact or abraded.

Applicant's summary and conclusion