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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

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

Data source

Reference Type:
Interspecies Comparisons of Skin Irritancy
Nixon G, Tyson C & Wertz W
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
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:
Not applicable to human studies

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Details on test material:
- Name of test material (as cited in study report): Isopropyl alcohol


Type of population:
not specified
No details provided
Ethical approval:
not specified
Route of exposure:
Reason of exposure:
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.
- 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:
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.
Effectivity of medical treatment:
Not applicable
Outcome of incidence:
Not applicable

Applicant's summary and conclusion