Registration Dossier

Administrative data

Endpoint:
skin irritation: 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other: GLP compliant, Non-guideline (screening) study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment.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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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:
Migrated information 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.