Cyclohexanemethanol, 4-(1-methylethyl)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Summer 1978.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Study appeared to follow OECD 405 with the following deviations: age of the animals not reported; eyes were not examined 24 hours pre-treatment; uncertain whether test material was placed in the conjunctival sac of the eye.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

age of the animals not reported; eyes were not examined 24 hours pre-treatment; uncertain whether test material was placed in the conjunctival sac of the eye.

Principles of method if other than guideline:

The Draize irritation procedure was applied.:
J.H. Draize, “Dermal toxicity”, in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, publ., The Association of Food and Drug Officials of the United States, 1959, p. 51.

GLP compliance:

no

Remarks:

Study pre-dates GLP

Test material

Test material information

Constituent 1

Reference substance name:

cis-4-(isopropyl)cyclohexanemethanol

EC Number:

237-539-8

EC Name:

cis-4-(isopropyl)cyclohexanemethanol

Cas Number:

13828-37-0

Molecular formula:

C10H20O

IUPAC Name:

cis-(4-propan-2-ylcyclohexyl)methanol

Constituent 2

Reference substance name:

trans-(4-propan-2-ylcyclohexyl)methanol

Cas Number:

13674-19-6

Molecular formula:

C10H20O

IUPAC Name:

trans-(4-propan-2-ylcyclohexyl)methanol

Test material form:

not specified

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated left eye served as the control.

Amount / concentration applied:

Instillation of 0.1 gram of the test material.

Duration of treatment / exposure:

single application

Observation period (in vivo):

All eyes were examined 24, 48, and 72 hours and at four, six, seven, and eight days after dosing.

Number of animals or in vitro replicates:

6 per group

Details on study design:

no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 96 hours

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal: #2 & #4

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #3 & #6

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.6

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

chemosis score

Basis:

animal: #1, #4 & #5

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 6

Irritation parameter:

chemosis score

Basis:

animal: #2, #3 & #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3, #4, #5 & #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3, #4, #5 & #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Other effects:

no data

Any other information on results incl. tables

Table 7.3.2/1: Irritant/corrosive response data each animal at each observation time up to removal from the test

 

Score at time point / Reversibility	Cornea	Iris (/2)	Conjunctivae
	Opacity (/4)		Redness (/3)	Chemosis (/4)	Discharge (/3)
24 h	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	2 / 2 / 1 / 2 / 1 / 1	1 / 0 / 0 / 1 / 1 / 0	2 / 0 / 1 / 1 / 2 / 0
48 h	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	1 / 1 / 0 / 1 / 1 / 0	0 / 0 / 0 / 0 / 0 / 0	1 / 0 / 0 / 0 / 1 / 0
72 h	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	1 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0
96 / 120 / 144h	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0
Average 24h, 48h, 72h	0.0 / 0.0 / 0.0 / 0.0 / 0.0 / 0.0	0.0 / 0.0 / 0.0 / 0.0 / 0.0 / 0.0	1.33 / 1.0 / 0.33 / 1.0 / 0.67 / 0.33	0.33 / 0.0 / 0.0 / 0.33 / 0.33 / 0.0	1.0 / 0.0 / 0.33 / 0.33 / 1.0 / 0.0
Reversibility*)	-	-	c.	c.	c.
Average time for reversion	-	-	72 h	48 h	72 h

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 E = scoring masked

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material caused slight eye irritation; however, these effects were not noted by 96 hours post-application. The mean scores of conjunctival redness and conjunctival oedema were below 2 in all animals following grading at 24, 48 and 72 hours after installation of the test material.

Executive summary:

The test material caused slight eye irritation; however, these effects subsided and were not noted in any animal by 96 hours post-application. The mean scores of conjunctival redness and conjunctival oedema were below 2 in all animals following grading at 24, 48 and 72 hours after installation of the test material. Based on the data, the substance was considered to be a slight primary irritant to the eye of the rabbit.