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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
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 it is an acceptable well-documented publication which meets basic scientific principles.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
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 it is an acceptable well-documented publication which meets basic scientific principles.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
Pre-GLP study
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2-3 kg
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
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
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: 24, 48, 72 hour scores not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: 24, 48, 72 hour scores not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: 24, 48, 72 hour scores not specified
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: 24, 48, 72 hour scores not specified
Irritant / corrosive response data:
1 animal had a redness score of 1 at 24 hrs. No other signs of irritation were noted.
Interpretation of results:
other: Not irritating
Remarks:
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.
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. 

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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
Pre-GLP study

Test material

Constituent 1
Reference substance name:
C-6 normal and iso paraffins (hexanes) and naphthenes (methyl-cyclohexane, dimethylcyclohexane), 25-35% n-hexane
IUPAC Name:
C-6 normal and iso paraffins (hexanes) and naphthenes (methyl-cyclohexane, dimethylcyclohexane), 25-35% n-hexane
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
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: 24, 48, 72 hour scores not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: 24, 48, 72 hour scores not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: 24, 48, 72 hour scores not specified
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: 24, 48, 72 hour scores not specified
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:
other: Not irritating
Remarks:
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.
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.