Registration Dossier

Administrative data

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other: GLP compliant, Non -guideline (screening) study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment.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

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues 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

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as a control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
2
Details on study design:
On the day prior to treatment both eyes of each rabbit were examined for irritation and corneal defects; only eyes free of irritation and defects were used. The test substance was dispensed immediately prior to dosing into a flask packed in dry ice. On the first treatment day, 0.1mL of the test substance was instilled into one eye of each rabbit. Irritation of the cornea, iris and conjunctivae was scored at 24, 48, and 72 hours after treatment. The maximum possible score for each time period was 110.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
110
Remarks on result:
other: there were no signs of eye irritation at any time point
Irritant / corrosive response data:
no signs of eye irritation
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 eyes.
Executive summary:

The eyes of rabbits were exposed to a single instillation of butadiene concentrate followed by a 72 hour observation period. No irritation occurred.