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EC number: 939-409-2 | CAS number: 1329-99-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to GLP and valid methods, however few data were available on test substance composition. Nevertheless it is considered relevant, reliable and adequate for classification.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of 1-Methyl-4-(1-methylethenyl)cyclohexene and 1-Methyl-4-(1-methylethylidene)-cyclohexene and 1-methyl-4-(propan-2-yl)cyclohexa-1,3-diene
- EC Number:
- 939-409-2
- Cas Number:
- 1329-99-3
- Molecular formula:
- C10H16
- IUPAC Name:
- Reaction mass of 1-Methyl-4-(1-methylethenyl)cyclohexene and 1-Methyl-4-(1-methylethylidene)-cyclohexene and 1-methyl-4-(propan-2-yl)cyclohexa-1,3-diene
- Reference substance name:
- Isopropylmethylcyclohexane, tetradehydro derivative
- EC Number:
- 215-532-0
- EC Name:
- Isopropylmethylcyclohexane, tetradehydro derivative
- Cas Number:
- 1329-99-3
- IUPAC Name:
- 1-isopropyl-4-methylcyclohexane
- Test material form:
- other: liquid
- Details on test material:
- The compound Depanol J is a colourless liquid. It was received at C.I.T. on the 23.11.84 in a plastic flask under the reference "Depanol J".
Note by CABB GmbH: handwritten notice of the plant manager, 'Depanol I' misread as 'Depanol J'.
A substance 'Depanol J' was never produced by Hoechst nor by subsequent companies.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino New Zealand, Hy / Cr
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River France (76410 Saint Aubin les Elbeuf, France)
- Age at study initiation: Not provided
- Weight at study initiation: 2390 g mean weight
- Fasting period before study: Not provided
- Housing: Individually in polystyrene cages (0.35 x 0.55 x 0.32 m); each cage was equipped with a food container and a water bottle.
- Diet (e.g. ad libitum): Ad libitum with a certified pelleted diet Rabbit Diet SQC (Special Diets Services Ltd, Witham, Essex England)
- Water (e.g. ad libitum): Tap water filtered with Millipore filters in water bottles ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 50% ± 30%
- Air changes (per hr): No data (The incoming, non recycled air, was filtered by an absolute filter.)
- Photoperiod (hrs dark / hrs light): 12/12
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 - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 4 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- A dose of 0.1 mL of the test compound was instilled into the inferior conjunctival sac of the left eye of each rabbit with a plastic syringe. The upper and lower eye lids were held together for several seconds to avoid any loss of test substance. The right eye served as control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.73
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 dyas
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.73
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 dyas
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Eye irritation evaluation
|
Scores |
D1 (1 hour) |
D2 (24 hours) |
||||||||||
|
Rabbit No. |
01 |
02 |
03 |
04 |
05 |
06 |
01 |
02 |
03 |
04 |
05 |
06 |
Con-junctivae |
Chemosis |
3 |
3 |
3 |
3 |
3 |
3 |
1 |
1 |
1 |
1 |
1 |
1 |
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Redness |
2 |
2 |
2 |
2 |
2 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
|
Iris |
Degree of congestion |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea |
Degree of opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Scores |
D3 |
D4 |
D5 |
||||||||||
|
Rabbit No. |
01 |
02 |
03 |
04 |
05 |
06 |
01 |
02 |
03 |
04 |
05 |
06 |
01 |
Con-junctivae |
Chemosis |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Redness |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
Degree of congestion |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea |
Degree of opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under these experimental conditions and according to the directive 83/467 EEC concerning classification, the packing and the labeling of the dangerous substances, the compound was considered as non-irritant.
- Executive summary:
An acute eye irritation study was performed with the compound Depanol I after instillation into the conjunctival sac of six New-Zealand rabbits, according to OECD Guideline 405 and the OECD Guideline for Good Laboratory Practice.
Chemosis, redness appeared in all animals on Day 1. These reactions disappeared between Day 4 and Day 5. No reactions were observed on the iris and cornea.
Under these experimental conditions and according to the Directive 83/467 EEC concerning classification, the packing and the labeling of the dangerous substances, the compound was considered as non-irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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