Cyclohexanepropanol, 2,2,3,6-tetramethyl-.alpha.-propyl-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10-04-2007 to 19-04-2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study performed under GLP. All relevant validity criteria were met.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

inspected: August 2005; signature: November 2005

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

478-330-3

EC Name:

-

Cas Number:

95851-08-4

Molecular formula:

C16H32O

IUPAC Name:

1-[(1R,3S,6S)-2,2,3,6-tetramethylcyclohexyl]hexan-3-ol

Test material form:

liquid

Details on test material:

- Physical state: Liquid
- Storage condition of test material: approximately 4°C in the dark
- Other: clear colourless slightly viscous liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Recognised Supplier
- Age at study initiation: 12 to 20 weeks
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: Individually housed in suspended cages.
- Diet (ad libitum): Certified Rabbit diet (Recognised Supplier); provided ad libitum
- Water (ad libitum): mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light / 12 hour dark

IN-LIFE DATES: From: 10-04-2007 To: 19-04-2007

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye remained untreated

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL ; which was determined to weigh approximately 91 mg (measured by gentle compacting into adapted syringe).
- Concentration (if solution): undiluted

VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable.
- Concentration (if solution): Not applicable.

Duration of treatment / exposure:

A volume of 0.1 mL of the test item, was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test item, and then released. The left eye remained untreated and was used for control purposes. Irrigation of the eye with distilled water or saline, after 1 hour was deemed not necessary during the study.

Observation period (in vivo):

Ocular assessment was conducted at approximately 1, 24, 48 and 72 hours after instillation of the test item, according to numerical evaluation.

Number of animals or in vitro replicates:

3 (male). Testing was conducted sequentially following testing with a sentinel.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM:
The irritation was assessed according to Draize (1977) numerical scoring system. At each observation period, the highest scores given were recorded. Any other ocular effects were also noted.

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.4

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

No corneal effects were noted, all scores were zero.
No iridial effects were noted, all scores were zero.
Moderate conjunctival irritation (score = 2) was noted in all treated eyes 1 h after treatment. Chemosis and Redness was minimal (score = 1 to 0) at the 24 h observation in all treated eyes and all effects had reversed (score = 0) at the 72 h observation.

Other effects:

- Lesions and clinical observations: None reported.
- Ophthalmoscopic findings: None reported.
- Histopathological findings: Not applicable.
- Effects of rinsing or washing: Not applicable.
- Other observations: Not applicable.

Any other information on results incl. tables

Table 1.0: Individual and Mean Scores for Cornea, Iris and Conjunctivae

Number and Sex	Time After Treatment	Corneal Opacity		Iridial Inflammation	Conjunctival Redness	Conjunctival Chemosis
1# Male	24 Hours	0		0	1	0
	48 Hours	0	0		0	0
	72 Hours	0	0		0	0
Total		0		0	1	1
Mean		0.0		0.0	0.3	0.0
#2 Male	24 Hours	0		0	1	1
	48 Hours	0	0		1	0
	72 Hours	0	0		0	0
Total		0		0	2	1
Mean		0.0		0.0	0.7	0.3
#3 Male	24 Hours	0		0	1	1
	48 Hours	0	0		1	0
	72 Hours	0	0		0	0
Total		0		0	2	1
Mean		0.0	0.0		0.7	0.3

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the test item is not irritating to the eye.

Executive summary:

The study was performed to OECD TG 405 and EU Method B.5 guidelines under GLP to assess the irritancy potential of the test item to the eye following a single application in the New Zealand White rabbit. A volume of 0.1 mL of the test item was placed into the conjunctival sac of one eye of three animals. The other eye remained untreated and was used for control purposes. The test was conducted in a stepwise manner conducted singularly and then on a further two rabbits in accordance with the guideline. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. A single application of the test item to the non-irrigated eye of three rabbits produced no corneal opacity, iridial inflammation and moderate conjunctival irritation (redness, score = 2) at one hour which was minimal (redness and chemosis, score = 1 to 0) after 24 hours. All treated eyes appeared normal at the 72-Hour observation (score = 0). Under the conditions of this study, the test item is not considered to be irritating to the eye.