Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
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:
Rabbits were clipped on the day prior to testing. 0.5 mL of p-xylene was applied to an intact and an abraded site on the backs of six rabbits. ( Epidermal abrasions made with a hypodermic needle). The application sites were covered with a gauze patch and the trunk of each animal was then loosely wrapped in a plastic sheet followed by a wrapping of paper towels. After a 4 h exposure period the wrappings and any excess material remaining were removed. The application sites were scored for irritation (Draize scale) 4 , 24 , 48 and 72 hours and 7 days.

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: 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.