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EC number: 267-184-4 | CAS number: 67801-64-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 July - 05 August 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted in compliance with OECD Guideline 405 without deviation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-tert-butylcyclohexyl ethyl carbonate
- EC Number:
- 267-184-4
- EC Name:
- 2-tert-butylcyclohexyl ethyl carbonate
- Cas Number:
- 67801-64-3
- Molecular formula:
- C13H24O3
- IUPAC Name:
- 2-tert-butylcyclohexyl ethyl carbonate
- Test material form:
- liquid
- Details on test material:
- - Physical state: Colourless liquid
- Storage condition of test material: Room temperature
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): SAT 950 744
- Date received: 24 July 1995
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Mol:Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre Ltd., Ejby, DK-4623 Lille Skensved.
- Weight at study initiation: 2.4-2.6 kg
- Housing: Animals were caged single in PPL cages (62 x 52 cm) with perforated floor.
- Diet: Feed pellets "Altromin 2123" from Altromin, D-32791 Lage, Lippe., ad libitum
- Water: Domestic quality drinking water acidified with hydrochloric acid to pH 2.5, ad libitum
- Acclimation period: At least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3 °C
- Humidity: 55 ± 15 %
- Air changes 10 times per hour
- Photoperiod: 12 h darkness / 12 h light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- No washing was done.
- Observation period (in vivo):
- 1, 24, 48 and 72 h after the treatment
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- As it was anticipated that the test article could cause marked changes in the eye, the study was initiated with 1 rabbit. Since no marked eye irritation was seen in this animal another 2 rabbits were included in the study.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: According to OECD guideline 405
TOOL USED TO ASSESS SCORE: Fluorescein; After the first 24 h reading Fluorescein was instilled. After rinsing with 20 mL 0.9 % sodium chloride solution the eyes were examined again using UV-light to detect possible corneal damage.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- - One hour after application erythema, oedema and discharge was observed in all animals.
- No reactions of the eyes were observed in any of animals 24 h after application. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: Individual ocular examinations and mean values of the scores recorded for each animal (24, 48 and 72 h)
Rabbit No./ Weight (kg) |
Lesions |
Scores for ocular lesions |
|||||
1 h |
24 h |
F |
48 h |
72 h |
Mean |
||
632/2.4 |
Area of opacity |
0 |
0 |
0 |
0 |
0 |
0.00 |
Cornea |
0 |
0 |
|
0 |
0 |
0.00 |
|
Iris |
0 |
0 |
|
0 |
0 |
0.00 |
|
Conjunctiva: Redness |
1 |
0 |
|
0 |
0 |
0.00 |
|
Conjunctiva: Chemosis |
2 |
0 |
|
0 |
0 |
0.00 |
|
Conjunctiva: Discharge |
3 |
0 |
|
0 |
0 |
0.00 |
|
638/2.6 |
Area of opacity |
0 |
0 |
0 |
0 |
0 |
0.00 |
Cornea |
0 |
0 |
|
0 |
0 |
0.00 |
|
Iris |
0 |
0 |
|
0 |
0 |
0.00 |
|
Conjunctiva: Redness |
1 |
0 |
|
0 |
0 |
0.00 |
|
Conjunctiva: Chemosis |
1 |
0 |
|
0 |
0 |
0.00 |
|
Conjunctiva: Discharge |
2 |
0 |
|
0 |
0 |
0.00 |
|
641/2.4 |
Area of opacity |
0 |
0 |
0 |
0 |
0 |
0.00 |
Cornea |
0 |
0 |
|
0 |
0 |
0.00 |
|
Iris |
0 |
0 |
|
0 |
0 |
0.00 |
|
Conjunctiva: Redness |
1 |
0 |
|
0 |
0 |
0.00 |
|
Conjunctiva: Chemosis |
1 |
0 |
|
0 |
0 |
0.00 |
|
Conjunctiva: Discharge |
2 |
0 |
|
0 |
0 |
0.00 |
|
F reading after instillation of Fluorescein SE Thilo
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, test item SAT 950 744 is not classified as irritating to eyes according to the criteria of Annex VI to the Regulation (EC) N°1272-2008 (CLP) and to the GHS.
- Executive summary:
In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy female Mol:Russian rabbits were exposed to 0.1 mL of test item SAT 950 744 in their left eye, while the right eye remained untreated and served as control. The eyelids were then gently held together for one second before releasing. The eyes were examined unwashed and the changes were observed at 1, 24, 48 and 72 h after instillation and graded according to the OECD guideline 405. After the first 24 h reading Fluorescein was instilled. After rinsing with 20 mL 0.9 % sodium chloride solution the eyes were examined again using UV-light to detect possible corneal damage.
One hour after application erythema, oedema and discharge was observed in all animals. No reactions of the eyes were observed in any of animals 24 h after application. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 0, 0, 0 for conjunctivae score and 0, 0, 0 for chemosis score.
Under the test conditions, test item SAT 950 744 is not classified as irritating to eyes according to the criteria of Annex VI to the Regulation (EC) N°1272-2008 (CLP) and to the GHS.
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