Registration Dossier
Registration Dossier
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EC number: 905-013-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from 1999-07-30 to1999-09-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed under GLP according to OECD TG 405. Read across from Isomenthone.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- DL-Isomenthone
- IUPAC Name:
- DL-Isomenthone
- Reference substance name:
- Isomenthone
- EC Number:
- 207-727-4
- EC Name:
- Isomenthone
- Cas Number:
- 491-07-6
- Molecular formula:
- C10H18O
- IUPAC Name:
- rel-(2R,5R)-2-isopropyl-5-methylcyclohexanone
- Test material form:
- other: colourless, liquid
- Details on test material:
- - Name of test material (as cited in study report): Isomenthone
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Deutschland GmbH, Stolzenseeweg 32-36, 88353 Kisslegg
- Age at study initiation: no data
- Weight at study initiation: 2.3-2.4 kg
- Housing: individually in PPO cages (floor area: 2576 cm^2) with perforated floor
- Diet (e.g. ad libitum): pelleted complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe, ad libitum.
- Water (e.g. ad libitum): domestic water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth, ad libitum.
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55±15
- Air changes (per hr): 10 times
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1999-08-23 To: 1999-08-31
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:
- once
- Observation period (in vivo):
- 1, 24, 48 and 72 hours as well as day 7 after the treatment.
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with 20 mL 0.9 % sodium chloride solution
- Time after start of exposure: 24 h
SCORING SYSTEM:
Cornea: opacity degree of density from 0 to 4; Area of cornea involved from 1 to 4
Iris: from 0 to 2
Conjunctiva: redness from 0 to 3; chemosis from 0 to 4; discharge from 0 to 3
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- degree
- Basis:
- animal #1
- Time point:
- other: readings after 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Remarks:
- degree
- Basis:
- animal #2
- Time point:
- other: readings after 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Remarks:
- degree
- Basis:
- animal #3
- Time point:
- other: readings after 24, 48 and 72 h
- Score:
- 0.2
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Remarks:
- degree
- Basis:
- animal #4
- Time point:
- other: readings after 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: readings after 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: readings after 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: readings after 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- other: readings after 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: readings after 24, 48 and 72 h
- Score:
- 1.33
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: readings after 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: readings after 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Time point:
- other: readings after 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: readings after 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: readings after 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: readings after 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- other: readings after 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Irritant / corrosive response data:
- On day 7 all animals were free of any signs of eye irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Isomenthone shall not be classified as eye irritating.
- Executive summary:
The eye irritant effect of Isomenthone was investigated according to the method recommended in the OECD TG 405, "Acute Eye Irritation/Corrosion", Feb. 1987, and EEC Guideline B.5 "Acute Toxicity (Eye Irritation)", Jan. 1997. Four female albino rabbits were exposed to 0.1 mL of the test article in the left eye. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours as well as day 7 after dosing. Slight to well-defined signs of irritation were observed an the treated eyes. No significant eye irritation according to CLP Regulation was observed in the tested animals from mean scores following their grading at 24, 48 and 72 hours after installation of the test material. On day 7 all animals were free of any signs of eye irritation. Therefore Isomenthone shall not be classified as eye irritating.
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