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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safety assessment report

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
LETTER FROM PHILLIPS PETROLEUM CO TO US EPA SUBMITTING UNPUBLISHED STUDIES ON CYCLOHEXANE WITH ATTACHMENTS
Author:
NTRL
Year:
1986
Bibliographic source:
NTRL REPORT- OTS0527456; January15, 1986
Reference Type:
secondary source
Title:
European Union Risk Assessment Report -CYCLOHEXANE
Author:
European Communities
Year:
2004
Bibliographic source:
European Union Risk Assessment Report -CYCLOHEXANE ; European Communities Final Report, 2004.

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Washed and unwashed primary eye irritation studies of chemical Cyclohexane (CAS No: 110-82-7) was performed in six male and female rabbits to assess its eye irritation potential.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report):Cyclohexane
- Molecular formula: C6H12
- Molecular weight: 84.16g/mole
- Substance type: organic
- Physical state: liquid
- InChI: 1S/C6H12/c1-2-4-6-5-3-1/h1-6H2
- Smiles: C1CCCCC1
Specific details on test material used for the study:
- Name of test material (as cited in study report):Cyclohexane
- Molecular formula: C6H12
- Molecular weight: 84.16g/mole
- Substance type: organic
- Physical state: liquid
- InChI: 1S/C6H12/c1-2-4-6-5-3-1/h1-6H2
- Smiles: C1CCCCC1

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data available

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
No data available
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Duration of post- treatment incubation (in vitro):
No data available
Number of animals or in vitro replicates:
6/group (3/sex)
Details on study design:
Details on study design
TEST SITE
- Time after start of exposure: 24 hours
-SCORING SYSTEM: according to Draize scoring system

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
110
Reversibility:
fully reversible within: 24 hours
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
In the unwashed study, at one hour post instillation, corneal opacity, involving up to 25% of the cornea, was noted in one rabbit and iritis was noted in another rabbit. Conjunctival redness was noted in five rabbits with conjunctival chemosis in one rabbit. All ocular lesions had cleared within 24 hours and no conjunctival discharge was noted in any of the six animals.

In the washed study, Conjunctival redness (vessels injected above normal) was noted in four rabbits at one hour postinstillation and had cleared by 24 hours. No corneal opacity, iritis, conjunctival chemosis, or discharge 'was noted in any of the six rabbits.

Any other information on results incl. tables

 

Table 1: Eye Irritation Score Ranges and Means d with Standard Deviations

washed Primary Eye Irritation Study of Cyclohexane in Rabbits

OBSERVATION

OBSERVATION INTERVALS

HOURS

DAYS

1

24

48

72

4

7

Cornea

 

 

 

 

 

 

Mean

0.0

0.0

0.0

0.0

0.0

0.0

S.D

0.0

0.0

0.0

0.0

0.0

0.0

Range

-

-

-

-

-

-

 

Iris

 

 

 

 

 

 

Mean

0.0

0.0

0.0

0.0

0.0

0.0

S.D

0.0

0.0

0.0

0.0

0.0

0.0

Range

-

-

-

-

-

-

 

Conjunctivae

 

 

 

 

 

 

Mean

1.3

0.0

0.0

0.0

0.0

0.0

S.D

1.0

0.0

0.0

0.0

0.0

0.0

Range

0-2

-

-

-

-

-

 

Total score

 

0.0

0.0

0.0

0.0

0.0

Mean

1..3

0.0

0.0

0.0

0.0

0.0

S.D

1.0

0.0

0.0

0.0

0.0

0.0

Range

0-2

-

-

-

-

-

*Mean based on six observations

 

 

 

 

 

 

 

Table 2: Eye Irritation Score Ranges And Means D With Standard Deviations

Unwashed Primary Eye Irritation Study Of Cyclohexane In Rabbits

OBSERVATION

OBSERVATION INTERVALS

HOURS

DAYS

1

24

48

72

4

7

Cornea

 

 

 

 

 

 

Mean

0.8

0.0

0.0

0.0

0.0

0.0

S.D

2.0

0.0

0.0

0.0

0.0

0.0

Range

0-5

-

-

-

-

-

 

Iris

 

 

 

 

 

 

Mean

0.8

0.0

0.0

0.0

0.0

0.0

S.D

2.0

0.0

0.0

0.0

0.0

0.0

Range

0-5

-

-

-

-

-

 

Conjunctivae

 

 

 

 

 

 

Mean

2.0

0.0

0.0

0.0

0.0

0.0

S.D

1.3

0.0

0.0

0.0

0.0

0.0

Range

0-4

-

-

-

-

-

 

Total score

 

0.0

0.0

0.0

0.0

0.0

Mean

3.7

0.0

0.0

0.0

0.0

0.0

S.D

2.9

0.0

0.0

0.0

0.0

0.0

Range

0-7

-

-

-

-

-

*Mean based on six observations

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
The test material was considered to be not irritating when installed into the eye of each rabbits in both the washed and unwashed primary eye irritation studies.
Executive summary:

Washed and unwashed primary eye irritation studies of chemical Cyclohexane (CAS No: 110-82-7) was performed in six male and female rabbits to assess its eye irritation potential.

 

The chemical was installed into the one of each animal and observations were made 24 hours after treatment.

 

In the unwashed study, at one hour post instillation, corneal opacity, involving up to 25% of the cornea, was noted in one rabbit and iritis was noted in another rabbit. Conjunctival redness was noted in five rabbits with conjunctival chemosis in one rabbit. All ocular lesions had cleared within 24 hours and no conjunctival discharge was noted in any of the six animals.

 

In the washed study, Conjunctival redness (vessels injected above normal) was noted in four rabbits at one hour postinstillation and had cleared by 24 hours. No corneal opacity, iritis, conjunctival chemosis, or discharge 'was noted in any of the six rabbits.

 

Since all the observed effects were cleared within 24 hours, the chemical Cyclohexane (CAS No: 110-82-7) was considered to be non-irritant to the eyes of rabbits.