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Registration Dossier
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EC number: 218-216-0 | CAS number: 2082-79-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 22,1982 - March 1,1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline, without GLP and only 7 day observation period
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- incomplete post observation period
- GLP compliance:
- no
Test material
- Reference substance name:
- Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- EC Number:
- 218-216-0
- EC Name:
- Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- Cas Number:
- 2082-79-3
- Molecular formula:
- C35H62O3
- IUPAC Name:
- octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- Details on test material:
- - Physical state: solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin
- Weight at study initiation: 2-3 Kg
- Housing: single
- Diet (e.g. ad libitum): standard diet, Nafag No.890
- Water (e.g. ad libitum): tap water
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 55±5
- Humidity (%): 22±2
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- not specified
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- 30 seconds
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 (washed eye group)
3 (unwashed eye group) - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, eyes of 3 rabbits flushed with 10 ml of physiological saline; eyes of 3 rabbits were kept unwashed
- Time after start of exposure: 30 s (3 rabbits)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 rabbits (not-rinsed and rinsed)
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 rabbits (not-rinsed and rinsed)
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 3 rabbits (not-rinsed)
- Time point:
- other: 24-48-72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: see free text for individual scores
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 3 rabbits (rinsed)
- Time point:
- other: 24-48-72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 rabbits (not-rinsed)
- Time point:
- other: 24-48-72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 rabbits (rinsed)
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
Any other information on results incl. tables
Animal No. |
Parameter |
Score at |
|||||
24 h |
48 h |
72 h |
4 days |
7 days |
24-72 h |
||
1 Not-rinsed |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
1 |
0 |
0 |
0 |
0 |
0.33 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 Not-rinsed |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
2 |
1 |
1 |
1 |
0 |
1.33 |
|
Chemosis |
1 |
0 |
1 |
1 |
0 |
0.67 |
|
3 Not-rinsed |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
0 |
0 |
1 |
1 |
1 |
0.33 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
1 Rinsed |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
0 |
0 |
0 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 Rinsed |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
0 |
1 |
0 |
0 |
0 |
0.33 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 Rinsed |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
2 |
0 |
0 |
0 |
0 |
0.67 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this experiment the test material was found to cause minimal irritation when applied to the rabbit eye mucosa below the level of significance.
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