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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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:
1982
Bibliographic source:
J American College of Toxicology, Volume 1, Number 4, 127-142
Reference Type:
other: Cited in publication
Title:
Unnamed
Year:
1979
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

Constituent 1
Chemical structure
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)

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:
Migrated information Criteria used for interpretation of results: other: EU (DSD)
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.