Registration Dossier
Registration Dossier
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EC number: 201-126-0 | CAS number: 78-59-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Etude de la toxicite d'un solvant industriel: l'isophorone - pouvoir irritant vis-a-vis des teguments et des muqueuses
- Author:
- Truhaut MR, Dutertre-Catella H, Phu-Lich MN, Daunet J
- Year:
- 1 972
- Bibliographic source:
- J. Europ. Toxicol. 5, 31-37
- Reference Type:
- other: OECD SIDS
- Title:
- 3,5,5-Trimethylcyclohex-2-enone (Isophorone), CAS No. 78-59-1
- Author:
- OECD SIDS
- Year:
- 2 003
- Bibliographic source:
- SIDS Initial Assessment Report for SIAM 16
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize Test according to the US Food and Drug Administration, Federal Register No. 191-11
- GLP compliance:
- no
Test material
- Reference substance name:
- 3,5,5-trimethylcyclohex-2-enone
- EC Number:
- 201-126-0
- EC Name:
- 3,5,5-trimethylcyclohex-2-enone
- Cas Number:
- 78-59-1
- Molecular formula:
- C9H14O
- IUPAC Name:
- 3,5,5-trimethylcyclohex-2-enone
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
Test system
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 mL - Duration of treatment / exposure:
- not rinsed; rinsed after 2 or 4 seconds, or rinsed after 24 hours
- Observation period (in vivo):
- 7 days and later until complete reversibility
- Number of animals or in vitro replicates:
- 3 (6 are rinsed after 24 hours)
- Details on study design:
- Not rinsed / rinsed after 2 seconds / 4 seconds (3 animals each)
Ophtalmoscopic examination after 24, 48, and 72 hours, 4 days, 7 days, and later until complete reversibility. Scoring system: Draize et al. (1944). J Pharmacol Exp Ther 82: 377-390
Results and discussion
In vivo
Results
- Remarks on result:
- other: see 'Irritant/corrosive response data' section for the results
- Irritant / corrosive response data:
- Scores are averages of results after 24, 48, and 72 hours. All effects are reversible.
Not rinsed
- Cornea: 15/80
- Iris: 0/10
- Conjuntivae: 7/20
- Overall irritation score: 22/110
Rinsed after 2 seconds
- Cornea: 21/80
- Iris: 0/10
- Conjuntivae: 6/20
- Overall irritation score: 27/110
Rinsed after 4 seconds
- Cornea: 12/80
- Iris: 0/10
- Conjuntivae: 5/20
- Overall irritation score: 17/110
Rinsed after 24 hours:
- Cornea: 14/80
- Iris: 0/10
- Conjuntivae: 6/20
- Overall irritation score: 20/110
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
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