Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
In Vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline study, GLP status not known, animal experimental study, limitations in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
7 day observation period
Principles of method if other than guideline:
0.5 mL of the undiluted compound was applied to an intact and to an abraded site on the backs of six rabbits. The sites were covered with a gauze patch. After a 4 h exposure period the patch and any excess material remaining were removed. 4 h, 24 h, 48 h, 72 h and seven-day scorings of irritation were made using the method of Draize.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
CHEVRON PARAXYLENE 99%, a clear liquid, was supplied by the Chevron Chemical Company, Industrial Chemicals Division, San Francisco, California.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Male rabbits
- Food and water available ad libitum
- Housing: The rabbits were housed individually in hanging wire bottom cages
- no further details

ENVIRONMENTAL CONDITIONS
- In an air-conditioned room where the temperature was maintained at approximately 70°F
- no further details

IN-LIFE DATES: no data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL of the undiluted material
Duration of treatment / exposure:
4 h
Observation period:
Up to 7 days
Number of animals:
6
Details on study design:
The rabbits were clipped on the day prior to testing. 0.5 mL of the undiluted compound was applied to an intact and to an abraded site on the backs of six rabbits. The epidermal abrasions were made with a hypodermic needle. The application sites were covered with a gauze patch. The trunk of each animal was then loosely wrapped in a plastic sheet followed by a wrapping of paper towels to prevent tearing of the plastic sheet. After a 4 h exposure period the wrappings and any excess material remaining were removed. 4 h, 24 h, 48 h, 72 h and seven day scorings of irritation were made using the method of Draize.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Score:
3
Remarks on result:
other: score is the summation of the average erythema and oedema for 24 and 72 hours divided by 4.
Irritant / corrosive response data:
In general, well-defined erythema and barely perceptible to slight oedema were observed throughout the seven-day observation period on intact skin. Similar irritation was observed on abraded application sites.
Other effects:
Primary Irritation Score: 3.0

Applicant's summary and conclusion

Interpretation of results:
other: moderately irritating; not corrosive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
CHEVRON PARAXYLENE 99% was not corrosive to the intact skin of the rabbits tested.
Executive summary:

The skin corrosion potential was determined by exposing the intact skin of six rabbits to p-xylene for four hours. The sites of application were not destroyed or changed irreversibly during or after the exposure. CHEVRON PARAXYLENE 99% was considered not to be corrosive to the intact skin of rabbits.