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Toxicological information

Eye irritation

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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:
2012
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

Constituent 1
Chemical structure
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)

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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