Registration Dossier
Registration Dossier
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EC number: 203-562-7 | CAS number: 108-22-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-04-20 to 1995-04-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Isopropenyl acetate
- EC Number:
- 203-562-7
- EC Name:
- Isopropenyl acetate
- Cas Number:
- 108-22-5
- Molecular formula:
- C5H8O2
- IUPAC Name:
- isopropenyl acetate
- Details on test material:
- Name: Isopropenylacetate
Supplied by: Wacker-Chemie GmbH, Johannes-HeB-StraBe 24, D-84489 Burghausen
Chemical name: 1-Propen-2-ol, acetate
Physical state: clear watery liquid
Identification: labelled, where appropriate, with name of test article, batch no., name of sponsor, project no., date of receipt, storage conditions, handling precautions and expiry date
Storage: ambient, protected from light
Expiry date : September 3, 1995
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species: rabbit
Strain: White New Zealands
Source: E. A. Prinzhorn, Altenbücker Damm 38,D-27333 Altenbücken
Animal identification: with individual ear tags; cage labelled with ear tag no., sex, date of study initiation, project no.
Housing:individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
illumination: artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.
Temperature: 20 +/- 3 °C
Relative humidity:30 -70 %
Measurement: twice daily
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other untreated eye
- Amount / concentration applied:
- 0.1 ml per eye
- Duration of treatment / exposure:
- Three animals were used. In each animal, 0.1 ml of the test article was introduced into the conjunctival sac of the left eye, the untreated right eye serving as control.
- Observation period (in vivo):
- Ocular reactions were assessed 1, 24, 48 and 72 h after treatment. On each occasion, ocular irritation was scored
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The test article was administered in the original state.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: any
- Score:
- 0 - 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: none
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: any
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: none
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: any
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: none
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: any
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: none
- Irritant / corrosive response data:
- GRADING OF OCULAR LESIONS (as stipulated by OECD 405)
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the basis of the EU directive and based on the results of the test, isopropenyl acetate was evaluated as not irritating to the eye.
- Executive summary:
In an eye irritation study with isopropenyl acetate, conducted in accordance with OECD guideline 405, 3 rabbits received an instillation of 0.1 ml undiluted test item (99.5% pure) into the conjunctival sac of one eye. One hour after treatment all animals were noted to have moderate redness of the conjunctivae and one animal exhibited slight swelling of the conjunctivae. At 24 h only one animal still exhibited mild redness of the conjunctivae, and 48 hours after treatment all animals were without abnormal findings. No other toxic effects were observed.On the basis of the EU directive and based on the results of the test, isopropenyl acetate was evaluated as not irritating to the eye
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