Registration Dossier
Registration Dossier
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EC number: 231-335-2 | CAS number: 7493-74-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 - 16 July 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- No information on purity was given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Modified Federal Hazardous Substances Labelling Act Method (Federal Register, 1964, 29 13009)
- GLP compliance:
- no
Test material
- Reference substance name:
- Allyl phenoxyacetate
- EC Number:
- 231-335-2
- EC Name:
- Allyl phenoxyacetate
- Cas Number:
- 7493-74-5
- Molecular formula:
- C11H12O3
- IUPAC Name:
- allyl phenoxyacetate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: at least 7 weeks
- Weight at study initiation: 1 - 2 kg
- Housing: singly before and during the test
- Diet: commercially available, pelleted diet, ad libitum
- Water: ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye was used as an untreated control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 7 days
Reading time points: 15 min and 24, 48 and 72 h and 7 days - Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize scoring system; Reaction to treatment considered to fall mid-way between the points
described was scored as a fraction (i.e. 0.5, 1.5, 2.5, etc).
TOOL USED TO ASSESS SCORE: slit lamp / fluorescein in one animal
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #2 and #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2 and #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The test substance caused slight corneal opacities affecting up to 0.5 of the cornea in all 3 animals. One animal also had slight conjunctivitis. One animal healed by Day 2, two by Day 7.
Any other information on results incl. tables
Table 1. Results of the eye irritation study.
Animal |
Time (h) |
Conjunctivae |
Cornea |
Iris |
|
Redness |
Chemosis |
||||
1 |
15 min |
1 |
0 |
- |
- |
1 |
1 |
0 |
0.5 |
0 |
|
2 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
|
Average 24+48+72 |
0.3 |
0 |
0.17 |
0 |
|
2 |
15 min |
1 |
0 |
- |
- |
1 |
0 |
0 |
0.5 |
0 |
|
2 |
0 |
0 |
0.5 |
0 |
|
3 |
0 |
0 |
0.5 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
|
Average 24+48+72 |
0 |
0 |
0.5 |
0 |
|
3 |
15 min |
1 |
0 |
- |
- |
1 |
0 |
0 |
0.5 |
0 |
|
2 |
0 |
0 |
0.5 |
0 |
|
3 |
0 |
0 |
0.5 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
|
Average 24+48+72 |
0 |
0 |
0.5 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of this eye irritation study in rabbits the test substance was not irritating to the eye.
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