Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
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.