Registration Dossier
Registration Dossier
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EC number: 213-701-3 | CAS number: 1003-14-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study (OECD 405)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Propyloxirane
- EC Number:
- 213-701-3
- EC Name:
- Propyloxirane
- Cas Number:
- 1003-14-1
- Molecular formula:
- C5H10O
- IUPAC Name:
- 2-propyloxirane
- Details on test material:
- - Name of test material (as cited in study report): n-Pentenoxid-1,2
- Physical state: colourless, liquid
- Analytical purity: 99.9%
- Substance No.: 81/355
- Expiration date of the lot/batch: 11/1982
- Storage condition of test material: keep cool
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: mean(males): 3.01 kg, female: 2.41 kg
- Housing: single
- Diet: daily ca. 130 g Ovator Solikanin 4 mm (Muskator-Werke) / animal
- Water: ad libitum (VE-water: monday-friday; tap water: saturday/sunday)
- Acclimation period: ca. 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Duration of treatment / exposure:
- see: observation period, no washing out conducted
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3 (2 males/1 female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing out conducted
SCORING SYSTEM: according to OECD 405 / J.H. Draize: Appraisal of the safety of chemicals in foods, drugs and cosmetics. In dermal toxicity pp. 46-59, 1959. Austin, Texas: Association of food and drug officials of the United States, Texas, State Department of Health
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: 2 animals with a cornea score of 1
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no signs of iritis
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24/48/72 h
- Score:
- 1.57
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: max. 72 h
- Other effects:
- - pathological findings: liver: parasitic affection in 1 animal; other animals: organs without abnormalities
Any other information on results incl. tables
| Cornea | Iris | Conjunctiva | ||||||
| Animal | Reading | Opacity | Area involved | Redness | Chemosis | Discharge | Comment | |
| 1 | 1 hrs | 0 | 0 | 0 | 2 | 2 | 2 | |
| 2 | 1 hrs | 0 | 0 | 0 | 2 | 2 | 2 | |
| 3 | 1 hrs | 0 | 0 | 0 | 2 | 2 | 2 | |
| 1 | 24 hrs | 0 | 0 | 0 | 2 | 1 | 1 | PC |
| 2 | 24 hrs | 1 | 4 | 0 | 2 | 1 | 1 | |
| 3 | 24 hrs | 1 | 3 | 0 | 2 | 1 | 1 | |
| 1 | 48 hrs | 0 | 0 | 0 | 1 | 0 | 0 | PC |
| 2 | 48 hrs | 1 | 3 | 0 | 2 | 0 | 0 | |
| 3 | 48 hrs | 1 | 2 | 0 | 2 | 0 | 1 | |
| 1 | 72 hrs | 0 | 0 | 0 | 1 | 0 | 0 | |
| 2 | 72 hrs | 1 | 2 | 0 | 1 | 0 | 0 | |
| 3 | 72 hrs | 1 | 2 | 0 | 1 | 0 | 0 | |
| 1 | 8 d | 0 | 0 | 0 | 0 | 0 | 0 | |
| 2 | 8 d | 0 | 0 | 0 | 0 | 0 | 0 | |
| 3 | 8 d | 0 | 0 | 0 | 0 | 0 | 0 | |
| 1 | 24/48/72 h | 0 | 0 | 1.3 | 0.3 | |||
| 2 | 24/48/72 h | 1 | 0 | 1.7 | 0.3 | |||
| 3 | 24/48/72 h | 1 | 0 | 1.7 | 0.3 | |||
| mean 1/2/3 | 24/48/72 h | 0.67 | 0.00 | 1.57 | 0.30 | |||
| PC pupil contracted | ||||||||
Primary irritation index: ca. 14
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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