Registration Dossier

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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Observation day past 7 days post exposure not planned
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
yes
Remarks:
Observation day past 7 days post exposure not planned
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Isooctane
- Analytical purity: 100% pure commercial product

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animals served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single treatment
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 males, 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes

SCORING SYSTEM: Draize scale for scoring ocular lesions

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: female rabbit
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effect
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effect
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effect
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
Conjunctival redness (grade 2) was noted in four rabbits at 1 hour post instillation and persisted in one rabbit to 24 hours. The redness reversed by 48 hours. No corneal opacity, iritis, conjunctival chemosis, or discharge was noted in any of the six rabbits.
Other effects:
No effects.

Any other information on results incl. tables

The initial protocol did not include provision for 21-day observation, but it was not necessary as all irritation reversed by 48 hours after instillation, which is acceptable per current protocols.

The test substance was not irritating to the eyes according to the criteria of the EU and the GHS.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: GHS, EU, 2007
Conclusions:
Based on the study design the test substance, Isooctane, is not irritating.
Executive summary:

Based on the study design the test substance, Isooctane, is not irritating.