3,5,5-trimethylcyclohex-3-en-1-one

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:

other: Comparable to guideline study. Restrictions: test substance purity not stated in SIDS

Data source

Reference

Reference 1

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:

1972

Bibliographic source:

J. Europ. Toxicol. 5, 31-37

Reference 2

Reference Type:

other: thesis

Title:

Contribution a l'etude analytique toxicologique et biochimique de l'isophorone.

Author:

Dutertre-Catella H

Year:

1976

Bibliographic source:

Universite Rene Descartes, Paris

Reference 3

Reference Type:

other: OECD SIDS

Title:

3,5,5-Trimethylcyclohex-2-enone (Isophorone), CAS No. 78-59-1

Author:

OECD SIDS

Year:

2003

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

Test material information

Constituent 1

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

IUPAC Name:

3,5,5-trimethylcyclohex-2-en-1-one

Details on test material:

- Analytical purity: not reported
- Origin: Elf Atochem S.A.

Test animals / tissue source

Species:

rabbit

Strain:

other: Fauve de Bourgogne

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:

irritating

Remarks:

Migrated information

Conclusions:

Classification: irritating