reaction mass of ethylbenzene and xylene

Skin irritation / corrosion

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

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

Test material information

Constituent 1

Reference substance name:

p-xylene

EC Number:

203-396-5

EC Name:

p-xylene

Cas Number:

106-42-3

Molecular formula:

C8H10

IUPAC Name:

p-xylene

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 or test system 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.