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EC number: 227-231-1 | CAS number: 5726-19-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 8, 2012 - June 28, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-methylcyclohexyl acetate
- EC Number:
- 227-231-1
- EC Name:
- 2-methylcyclohexyl acetate
- Cas Number:
- 5726-19-2
- Molecular formula:
- C9H16O2
- IUPAC Name:
- 2-methylcyclohexyl acetate
- Details on test material:
- - Name of test material (as cited in study report): 2-methylcyclohexylacetate
- Physical state: liquid
- Analytical purity: 99.33% weight
- Lot/batch No.: DNTL/OMCHA/020212
- Expiration date of the lot/batch: 15 March 2013 (allocated by NOTOX, 1 year after receipt of the test substance)
- Storage condition of test material: At room temperature in the dark and dry (avoid moisture due to the reactivity)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: at least 1.0 kg
- Housing: Individually, in cages with perforated floors (dimensions 67 x 62 x 55 cm) and shelters (dimensions 40 x 32 x 23 cm).
- Diet (e.g. ad libitum): Ad libitum.
- Water (e.g. ad libitum): Ad libitum.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24°C
- Humidity (%): 40 - 70%
- Air changes (per hr): 15 room air changes/hour
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were not rinsed with tap water since no residual test substance was present.
SCORING SYSTEM: Grading of ocular lesions according to OECD 405 and EU method B.5.
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean 24-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean 24-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean 24-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean 24-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean 24-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean 24-72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean 24-72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean 24-72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean 24-72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean 24-72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean 24-72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Instillation of 0.1 mL of 2-methylcyclohexylacetate into one eye of each of three rabbits resulted in effects on the iris and conjunctivae. Iridial irritation grade 1 was observed in two animals, one hour after instillation only. The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 7 Days in all animals.
- Other effects:
- - Ophthalmoscopic findings: No staining of (peri) ocular tissues by the test substance was observed and no test substance remnants were seen. There was no evidence of ocular corrosion.
- Other observations: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Mean value eye irritation scores:
Animal |
Mean 24, 48 and 72 hours |
|||
Corneal opacity |
Iris |
Conjunctivae |
||
Redness |
Chemosis |
|||
294 |
0.0 |
0.0 |
3.0 |
1.3 |
293 |
0.0 |
0.0 |
2.0 |
0.3 |
296 |
0.0 |
0.0 |
1.7 |
0.3 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Instillation of 0.1 mL of 2-methylcyclohexylacetate into one eye of each of three rabbits resulted in effects on the iris and conjunctivae. The test substance was determined to be classified as irritating to eyes (category 2) according to CLP Regulation (EC) No 1272. 2008.
- Executive summary:
An acute eye irritation/corrosion study was performed on 2 -methylcyclohexyl acetate in accordance with OECD Guideline 405. Single samples of 0.1 mL of 2-methylcyclohexylacetate were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7 days after instillation. Iridial irritation grade 1 was observed in two animals, only one hour after instillation (fully reversible within 24 hours). The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 7 Days in all animals. No corneal opacity was observed and there was no evidence of ocular corrosion. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. Based on these results, 2 -methylcyclohexyl acetate was determined to be classified as irritating to eyes (category 2) according to CLP Regulation (EC) No 1272/2008.
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