Registration Dossier
Registration Dossier
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EC number: 200-814-8 | CAS number: 74-84-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Information from review article, reliability not known but contributing to a weight of evidence assessment
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Final report of the safety assessment of isobutane, isopentane, n-butane and propane
- Author:
- Anon
- Year:
- 1 982
- Bibliographic source:
- J American College of Toxicology, Volume 1, Number 4, 127-142
- Reference Type:
- other: Cited in publication
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Principles of method if other than guideline:
- No guideline specified. Rabbit eye irritation study.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Isobutane
- EC Number:
- 200-857-2
- EC Name:
- Isobutane
- Cas Number:
- 75-28-5
- Molecular formula:
- C4H10
- IUPAC Name:
- isobutane
- Details on test material:
- - Name of test material (as cited in study report): isobutane
- Substance type: Hair spray
- Analytical purity: 22% isobutane (no further details of hair spray composition reported)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No details
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted hair spray containing 22% isobutane - Duration of treatment / exposure:
- Single instillation, after 4 seconds the eye was irrigated.
- Observation period (in vivo):
- At least 1 hour (no further details reported)
- Number of animals or in vitro replicates:
- 5
- Details on study design:
- No further details
Results and discussion
In vivo
Results
- Irritation parameter:
- other: eye irritation
- Basis:
- other: Descriptive comment on irritant reaction
- Time point:
- other: No irritation scores
- Score:
- 0
- Reversibility:
- fully reversible within: after 1 hour
- Irritant / corrosive response data:
- There was no sign of corneal irritation after 1 hour. There was transient iritis and mild conjunctivitis after 1 hour but these soon disappeared.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: other: EU (GHS/CLP)
- Conclusions:
- Following instillation of 0.1 mL of hair spray, which contained 22% isobutane, to the eyes of 5 rabbits (followed by irrigation after 4 seconds), there was no sign of corneal irritation after 1 hour. Transient iritis and mild conjunctivitis were present after 1 hour but these soon disappeared.
- Executive summary:
Following instillation of 0.1 mL of hair spray, which contained 22% isobutane, to the eyes of 5 rabbits (followed by irrigation after 4 seconds), there was no sign of corneal irritation after 1 hour. Transient iritis and mild conjunctivitis were present after 1 hour but these soon disappeared.
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