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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:
key study
Study period:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because there was no GLP statement provided, and limited data on methods were reported, but the study seemed to be well-conducted.

Data source

Reference
Reference Type:
publication
Title:
The Toxicological Properties of Hydrocarbon Solvents
Author:
Hine, CH, and Zuidema, HH
Year:
1970
Bibliographic source:
Industrial Medicine, Vol. 39, No. 5, May 1970.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): S-1
- Composition of test material, percentage of components: C-6 normal and iso paraffins (hexanes) and naphthenes (methyl-cyclohexane, dimethylcyclohexane), 25-35% n-hexane

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2-3 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye used as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
72 hrs
Observation period (in vivo):
72 hrs
Number of animals or in vitro replicates:
6 males
Details on study design:

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1-72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1-72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1-72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1-72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
1 animal had a redness score of 1 at 24 hrs. No other signs of irritation were noted.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean conjunctivae, chemosis, iris, and cornea scores were 0.33, 0.0, 0.0 and 0.0 respectively. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

This study examined the potential of hexane to cause irritation to eyes. 0.1 ml of test substance was placed in the eyes of six male rabbits. The rabbits were examined for signs of irritation at 24, 48, and 72 hrs after start of exposure. Only 1 animal showed signs of irritation (score of 1) at 24 hrs. The mean conjunctivae, chemosis, iris, and cornea scores were 0.33, 0.0, 0.0, and 0.0 respectively. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.