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 Mar - 10 Apr 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions; no data on analytical purity of the test substance were given.
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 stearate
- Details on test material:
- - Substance type: stearic acid methyl ester
- Physical state: white solid
- Purity: not specified
- Expiration date of the lot/batch: 17 Sept 1992
- Storage condition of test material: room temperature
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: Ssniff rabbit diet K4, ad libitum
- 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: the untreated eye served as control
- 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 hours
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE:
- Washing (if done): yes, rinsing with tap water
- Time after start of exposure: 24 hours
SCORING SYSTEM: according to the council directive 84/449/EEC (Draize scoring system)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: no effect in any animal
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: no effect in any animal
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: slight redness graded 1 was seen at each of reading time point 1 and 24 hour.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: redness graded 2 was seen at reading time point 1 hour, which turned to slight (grade 1) at 24 and 48 hour.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: in this animal, redness graded 2 was seen at reading time point 1 hour only.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: no effect in any animal
- Irritant / corrosive response data:
- One hour after exposure conjunctival redness graded 1 to 2 was seen in all 3 animals. In two cases, redness of grade 1 was further seen at 24 hour whereas the third animal had recovered. One animal still showed redness grade 1 at 48 hour, which finally was no more evident at reading time point 72 hour.
Any other information on results incl. tables
Evaluation of the eye lesions at reading time points 24, 48 and 72 hours
Animal |
Hours after application |
||||||||||||||
24 |
48 |
72 |
|||||||||||||
A |
B |
C |
D |
L |
A |
B |
C |
D |
L |
A |
B |
C |
D |
L |
|
1241 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1250 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1267 |
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
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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