Registration Dossier
Registration Dossier
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EC number: 295-405-4 | CAS number: 92045-23-3 A complex combination of hydrocarbons produced by the distillation of the products of a steam cracking process. It consists predominantly of hydrocarbons having a carbon number of C4, predominantly 1-butene and 2-butene, containing also butane and isobutene and boiling in the range of approximately minus 12°C to 5°C (10.4°F to 41°F).
Eye irritation
Administrative data
- Endpoint:
- eye irritation, 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- other: GLP compliant, Non -guideline (screening) study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment.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-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- 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 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.
- 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
Constituent 1
Constituent 2
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:
- 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.
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