4-(1,1-dimethylethyl)cyclohexyl methacrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Initiation date: 27-11-'84 Completion date: 30-11-'84

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

4-(1,1-dimethylethyl)cyclohexyl methacrylate

EC Number:

256-277-5

EC Name:

4-(1,1-dimethylethyl)cyclohexyl methacrylate

Cas Number:

46729-07-1

Molecular formula:

C14H24O2

IUPAC Name:

4-tert-butylcyclohexyl 2-methylprop-2-enoate

Specific details on test material used for the study:

Chemical name (IUPAC): t-Butyl cyclohexyl methacrylate
Trade name/code: Nourycryl MC 110
Appearance: Clear mobile liquid
Storage: At ambient temperature in the dark
Purity > 98%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three adult female rabbits of the New Zealand White strain were obtained from Van Zutphen Breeding Centre, Keldonk, The Netherlands. Date of arrival at the animal house: 27-09-'84. From that date on, the animals, designated A1, A2 and A3, have been individually housed in metal cages with perforated floors (RUCO, Val kenswaard). Their body weights were measured 5 days before dose administration. They were fed standard laboratory animal diet (120 g per day), obtained from Hope Farms, Woerden (LK-01, pellet diameter 4 mm), and had free access to tap water,. The animal room temperature was 20 ± 1 ºC and the relative humidity 50-70 percent. The artificial light sequence was 12 hours light, 12 hours dark.

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1ml undiluted test item

Duration of treatment / exposure:

single treatment

Observation period (in vivo):

The eyes were examined 1 hour and approximately 24, 48 and 72 hours after instillation of the test substance.

Number of animals or in vitro replicates:

three females

Details on study design:

Administration of the test substance
The animals were held in a physical restrainer (Tecniplast, Italy) during dose administration. 0.1 ML of the test substance was instilled in the conjunctival sac of the right eye of each animal using a syringe. The lids were then held gently together for two seconds-and released. Immediately after treatment, the animals were transferred to their cages. The left eye, remaining untreated, served as a control.

Observations
Prior to dose administration, both eyes of the animals were inspected in order to detect any eye defect. Immediately after instillation of the test substance, the animals were observed and abnormalities were recorded. In addition, the eyes were examined 1 hour and approximately 24, 48 and 72 hours after instillation of the test substance.

Fluorescein treatment
Approximately twenty-four hours after instillation of the test substance (immediately after scoring the corneal opacity and alterations of iris and conjunctivae), a solution of 2% fluorescein in water (pH adjusted to 7 .0) was applied to both eyes of each animal to quantitatively examine the potential for corneal injury. The brightly green staining area indicating epithelial damage was estimated as a percentage of the total corneal area.
Any observed local effects other than those indicated above were recorded.

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:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

One hour after test substance instillation slight reddening of the conjunctivae was observed in all animals and swelling of the eye lids in two animals. However, 24 hours after treatment no effects on the cornea, the iris and the conjunctivae had remained in any of the rabbits. Treatment of
the eyes with fluorescein 24 hours after instillation of the test substance did not reveal any epithelial damage.
According to the criteria laid down in Annex VI of the EEC Council Directive 67/548/EEC, the test substance can be classified as a non-irritant to the eye.

Any other information on results incl. tables

 Eye irritation scores for Nourycryl MC110 in the rabbit

Rabbit No. and sex	Body weight (grams)	Observation time after exposure period (hours)	Cornea opacity	Iris lesion	Conjunctival redness	Conjunctival Swelling (chemosis)
A1 Female		1	0	0	1	2
		24	0	0	0	0
		48	0	0	0	0
		72	0	0	0	0
Subtotal (a) / Mean value (c)			0/0	0/0	0/0	0/0
A3 Female	2426	1	0	0	1	0
		24	0	0	0	0
		48	0	0	0	0
		72	0	0	0	0
Subtotal (a) / Mean value (c)			0/0	0/0	0/0	0/0
A5 Female	2454	1	0	0	1	1
		24	0	0	0	0
		48	0	0	0	0
		72	0	0	0	0
Subtotal (a) / Mean value (c)			0/0	0/0	0/0	0/0
Total (b) / Mean value			0/0	0/0	0/0	0/0

a) Subtotal = sum of 24-, 48- and 72-hour score calculated for each animal individually

b) Total = sum of 24-, 48- and 72-hour score calculated for all animals

c) Mean value = mean score of 24-, 48- and 72-hour reading times

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

24 hours after treatment no effects on the cornea, the iris and the conjunctivae had remained in any of the rabbits. Treatment of the eyes with fluorescein 24 hours after instillation of the test substance did not reveal any epithelial damage.
Therefore the substance is not classified for eye irritation according to CLP.

Executive summary:

A sample of Nourycryl MC 110 was tested in the rabbit acute eye irritation test to determine its possible irritating effects. No persistent effects were observed during the 72-hour observation period following instillation of 0.1 ml of the test substance into the left eye of 3 adult female rabbits. Therefore it is concluded that the test substance is a non-irritant to the eye.