Registration Dossier
Registration Dossier
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EC number: 200-922-5 | CAS number: 75-98-9
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: Acceptable, well-documented study report equivalent or similar to OECD guideline (405): pre-GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Draize method
- GLP compliance:
- no
Test material
- Reference substance name:
- Pivalic acid
- EC Number:
- 200-922-5
- EC Name:
- Pivalic acid
- Cas Number:
- 75-98-9
- Molecular formula:
- C5H10O2
- IUPAC Name:
- 2,2-dimethylpropanoic acid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.2 ml
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- The conjunctival redness chemosis and discharge, corneal opacity and damge to the iris following the instillation of 0.2 mL undiluted chemical into the conjunctival sac of two rabbit eyes was scored using standard scales.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1-2 h
- Score:
- 6.3
- Remarks on result:
- other: out of 16 (Cornea, Iris and Conjunctivae)
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 9.6
- Remarks on result:
- other: out of 16 (Cornea, Iris and Conjunctivae)
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 10
- Remarks on result:
- other: out of 16 (Cornea, Iris and Conjunctivae)
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 9.7
- Remarks on result:
- other: out of 16 (Cornea, Iris and Conjunctivae)
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 3.8
- Remarks on result:
- other: out of 16 (Cornea, Iris and Conjunctivae)
- Other effects:
- Severe pain response
Any other information on results incl. tables
|
Mean response |
||||
|
1-2 hours |
1 day |
2 days |
3 days |
7 days |
Conjunctiva |
|
|
|
|
|
Redness |
2.0 |
2.0 |
2.0 |
2.0 |
1.0 |
Chemosis |
2.0 |
3.0 |
3.0 |
2.5 |
0 |
Discharge |
0.3 |
1.0 |
1.0 |
1.2 |
0 |
Cornea |
|
|
|
|
|
Opacity |
2.0 |
2.0 |
2.0 |
2.0 |
1.5 |
Area |
4.0 |
4.0 |
4.0 |
4.0 |
4.0 |
Iris |
0 |
1.6 |
2.0 |
2.0 |
1.3 |
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information
- Conclusions:
- The test material was severely irritating to rabbit eyes.
- Executive summary:
On the basis of this study pivalic acid is considered to be an irritant to the eye.
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