Registration Dossier
Registration Dossier
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EC number: 203-990-4 | CAS number: 112-61-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31.03.1992 - 10.04.1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- analytical purity of test substance not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl stearate
- EC Number:
- 203-990-4
- EC Name:
- Methyl stearate
- Cas Number:
- 112-61-8
- Molecular formula:
- C19H38O2
- IUPAC Name:
- methyl octadecanoate
- Details on test material:
- - Substance type: Stearic acid methyl ester
- Physical state: Solid, white
- Purity: Not specified
- Expiration date of the lot/batch: 17.09.1992
- Storage condition of test material: RT
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrussen , Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Thomae GmbH, Biberach, Germany
- Age at study initiation: approx. 15 months
- Weight at study initiation: approx. 2800 g
- Housing: individually
- Diet: ad libitum (Ssniff rabbit diet K4)
- Water: ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye untreated
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (=0.7 g) - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE:Rinsing with tap water
SCORING SYSTEM: according to the council directive 84/449/EEC
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: no effects in any animal
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Remarks on result:
- other: no effects in any animal
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: no effects in any animal
Any other information on results incl. tables
Evaluation of the eye lesions
Animal |
Hours after application |
||||||||||||||
24 |
48 |
72 |
|||||||||||||
A |
B |
C |
D |
L |
A |
B |
C |
D |
L |
A |
B |
C |
D |
L |
|
1242 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1315 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
1316 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
A = Corneal Reaction
B = Effects on the iris
C = Erythem
D = Chemosis
L = Lacrimation
Within 72 h all test animals were without any signs of irritation effects on their treated eyes. According to DSD and CLP the test substance has not to be classified.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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