Registration Dossier
Registration Dossier
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EC number: 411-490-4 | CAS number: 7027-11-4 ISOPHORONENITRILE, IPN
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06-22-1990 - 10-15-1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
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:
- 3-cyano-3,5,5-trimethylcyclohexanone
- EC Number:
- 411-490-4
- EC Name:
- 3-cyano-3,5,5-trimethylcyclohexanone
- Cas Number:
- 7027-11-4
- Molecular formula:
- C10H15NO
- IUPAC Name:
- 3-cyano-3,5,5-trimethylcyclohexanone
- Details on test material:
- IUCLID4 Test substance: other TS: Isophorone nitrile of Degussa AG. Batch No. 64 II / 192 V / 89. Purity 99.8 % (GC).
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: White Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Strain: White Russian
- Source: ASTA Pharma AG, Bielefeld (Germany)
- Sex: 1 male, 2 females
- Age: 11 months
- Weight at study initiation: male 2.63 kg, females 2.34 and 2.87 kg
- Housing: single housing
- Diet: ad libitum, special diet for rabbits, SSniff K
- Water: ad libitum, tab water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 40 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- - undiluted
- Amount of substance instilled: ca. 0.1 ml = 0.06 - 0.1 g - Duration of treatment / exposure:
- eye not rinsed
- Observation period (in vivo):
- 3 days after application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- EXAMINATIONS
- eye not rinsed
- Ophtalmoscopic examination: 1, 24, 48, 72 hours after treatment
- Scoring system: Draize scores; evaluation: Gilman et al. (1983)
- Tool used to assess score: Cliptrix pencil light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjunctivae : 0.33 ( 24h; 48h; 72h)
- Overall irritation score: 2/110
REVERSIBILITY: complete within 48 hours - Other effects:
- DESCRIPTION OF LESIONS: Hyperemia (vessels injected) in conjunctiva. Discharge with moistening of lids and hair just adjacent to lids and
considerable areas around the eye (at 24 hours).
Any other information on results incl. tables
no further remarks
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Draize Scores and according to EU Directive 67/548/EEC
- Conclusions:
- Classification: not irritating
- Executive summary:
Isophorone nitrile was investigated for irritant effects on the eye and associated mucous membranes of 1 male and 2 female rabbits. The test substance was applied in a single mean dose of 0.06 - 0.1 gram into one conjuntival sac each of three animals. At cornea and iris no alterations were detectable, the conjunctiva showed hyperemia (vessels injected). Additional lesions were discharge with moistening of lids and hair just adjacent to lids and considerable areas around the eye. The findings were recorded up to 24 hours after application. With an irritation index of 2.0/110 isophorone nitrile
is classified as non-irritant on the eye of the rabbit.
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