3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarbonyl chloride

Eye irritation

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

Reference

Reference 1

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LETTER FROM PHILLIPS PETROLEUM CO TO US EPA SUBMITTING UNPUBLISHED STUDIES ON CYCLOHEXANE WITH ATTACHMENTS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 2

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

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

Test material information

Constituent 1

Reference substance name:

Cyclohexane

Cas Number:

110-82-7

Molecular formula:

C6H12

IUPAC Name:

Cyclohexane

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.