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EC number: 256-277-5 | CAS number: 46729-07-1
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- Aquatic toxicity
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- Short-term toxicity to fish
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- Terrestrial toxicity
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
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- Additional toxicological data

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:
- 1 984
- 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
- 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
Constituent 1
- 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
Resultsopen allclose all
- 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
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- 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
- 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.
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