Registration Dossier
Registration Dossier
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EC number: 202-790-4 | CAS number: 99-82-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01/03 1989 to 07/03 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: conform guideline, non GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- p-menthane
- IUPAC Name:
- p-menthane
- Reference substance name:
- 1-isopropyl-4-methylcyclohexane
- EC Number:
- 202-790-4
- EC Name:
- 1-isopropyl-4-methylcyclohexane
- Cas Number:
- 99-82-1
- Molecular formula:
- C10H20
- IUPAC Name:
- 1-methyl-4-(propan-2-yl)cyclohexane
- Details on test material:
- - Name of test material (as cited in study report): p-menthane
- Physical state: liquid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: white russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Tomae GmbH Biberach
- Sex: male
- Weight at study initiation: 2.4 kg
- Housing: individual
- Diet : K4 Alleindiät für Kaninchen, Ssniff Spezialfütter GmbH Soest, ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±1
- Humidity (%): 60 ±5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 01 March 1989 To: 07 March 1989
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 cm3 in the conjunctival sac, washed with physiological saline after 72 h
- Duration of treatment / exposure:
- washed with physiological saline after 72 h
- Observation period (in vivo):
- at 1, 24, 72 h and 6 days after application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: after 72 h
SCORING SYSTEM: draize
TOOL USED TO ASSESS SCORE: at the 72 h observation fluorescein was used to assess corneal effects
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 24 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 48 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritant / corrosive response data:
- No irritant effects were observed
Any other information on results incl. tables
| 1 hour |
| Conjuntivae | 24 hours | Conjuntivae | 48 hours | Conjuntivae | 72 hours | Conjuntivae | 6 days | Conjuntivae | ||||||||||||||
| Cornea | Iris | R | C | D | Cornea | Iris | R | C | D | Cornea | Iris | R | C | D | Cornea | Iris | R | C | D | Cornea | Iris | R | C | D |
Animal 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Animal 2 | 0 | 0 | 2 | 1 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Animal 3 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not irritating to eyes.
- Executive summary:
In an eye irritation test with rabbits no irritating effects of the test substance became apparent.
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