Hydrocarbons, C3-4

Skin irritation / corrosion

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other: GLP compliant, Non-guideline (screening) study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

two young adult rabbits were evaluated for eye and skin irritation in a screening study

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Gases (petroleum), light steam-cracked, butadiene conc.

EC Number:

273-265-5

EC Name:

Gases (petroleum), light steam-cracked, butadiene conc.

Cas Number:

68955-28-2

IUPAC Name:

Gases (petroleum), light steam-cracked, butadiene conc.

Constituent 2

Reference substance name:

Butadiene Concentrate

IUPAC Name:

Butadiene Concentrate

Details on test material:

- Name of test material (as cited in study report): Butadiene Concentrate
- Substance type: Gases (petroleum) light steam-cracked
- Composition of test material, percentage of components: Approximately 67% 1,3-butadiene, 30% butenes, 2% 1,2-butadiene

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: 1 male and 1 female
- Supplied by: Sunrise Lab Animals, Whitehouse Station, New Jersey, USA
- Acclimatisation period: minimum of 5 days
- Age: Young adult

ENVIRONMENTAL CONDITIONS: not reported

IN-LIFE DATES: not reported

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

24 hours

Observation period:

7 days

Number of animals:

2

Details on study design:

TEST SITE: Side and back
- Type of wrap if used: Webril patch secured by gauze and secured by gauze and tape. The trunk was then wrapped with an occlusive rubber dam. Rabbits were also fitted with Elizabethan collars to prevent chewing of the rubber dam and ingestion of the test substance.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped with cotton dampened with physiological saline
- Time after start of exposure: 24 hours

SCORING SYSTEM: Irritation index was calculated using scores at 26 hours, 72 hours and 7 days after the start of application

Results and discussion

In vivo

Results

Irritation parameter:

other: Irritation index

Score:

ca. 0.3

Max. score:

8

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: the mean score at 26 h was 0.3, there were no effects after 72h or 7days

Irritant / corrosive response data:

The mean erythema score at the 26 hour reading (2 hours after removal of dressing) was 0.5. No erythema or oedema was present at any of the other readings. The irritation index was calculated to be 0.3/8.0.

Other effects:

none

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Butadiene concentrate was not irritating to rabbit skin.

Executive summary:

The skins of rabbits were exposed to butadiene concentrate for 24h followed by a 7 day observation period. No irritation occurred.