Registration Dossier
Registration Dossier
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EC number: 214-406-2 | CAS number: 1125-21-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD 405 and EEC Directive 92/69. Test conducted under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,6,6-trimethylcyclohex-2-ene-1,4-dione
- EC Number:
- 214-406-2
- EC Name:
- 2,6,6-trimethylcyclohex-2-ene-1,4-dione
- Cas Number:
- 1125-21-9
- Molecular formula:
- C9H12O2
- IUPAC Name:
- 2,6,6-trimethylcyclohex-2-ene-1,4-dione
- Reference substance name:
- Oxoisophoron
- IUPAC Name:
- Oxoisophoron
- Reference substance name:
- 2,6,6-trimethyl-2-cyclohexen-1,4-dion
- IUPAC Name:
- 2,6,6-trimethyl-2-cyclohexen-1,4-dion
- Details on test material:
- - name of test substance: Oxoisophoron
- chemical name: 2,6,6-Trimethyl-2-cyclohexene-1,4-dion
- substance number: 96/87
- CAS number: 1125-21-9
- degree of purity/content: 98.87%
- date of manufacturing: 18-may-1995
- physical state/appearance: solid, yellow (at room temperature); liquid, yellowish (at 50 °C)
- storage conditions: room temperature
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harln Winkelmann GmbH, (Interfauna, United Kingdom)
- Age at study initiation: young adult animals
- Weight at study initiation: 3.41 - 3.55 kg
- Housing: single in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet (e.g. ad libitum): Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland; about 130 g per animal per day.
- Water (e.g. ad libitum): tap water; about 250 mL/day/animal
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eyes served as controls.
- Amount / concentration applied:
- 0.1 mL of the unchanged test substance.
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 (2 males and 1 female).
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): tap water
- Time after start of exposure: 24 h
SCORING SYSTEM:
- Cornea opacity: values 0-4
- Conjunctivae redness: values 0-3
- conjunctivae discharge: values 0-3
- Chemosis: values 0-4
- iris: values 0-2
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- other: animal #1, #2 and #3
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: individual scores: 0 - 0 - 0
- Irritation parameter:
- cornea opacity score
- Basis:
- other: animal #1, #2 and #3
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: individual scores: 0 - 0 - 0
- Irritation parameter:
- conjunctivae score
- Basis:
- other: animals #2 and #3
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual scores: 1 - 0 - 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual scores: 2 - 1 - 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual scores: 1 - 0 - 0
- Irritation parameter:
- chemosis score
- Basis:
- other: animals #2 and #3
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: individual scores: 0 - 0 - 0
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions chosen and considering the described findings oxoisophoron does not give indication of an irritant property to the eye. No classification is needed according to EU Directive 67/548/EEC and Regulation (EC) No. 1272/2008.
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