Registration Dossier
Registration Dossier
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EC number: 204-680-1 | CAS number: 124-10-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1992-03-31 to 1992-04-10
- 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 laurate
- EC Number:
- 203-911-3
- EC Name:
- Methyl laurate
- Cas Number:
- 111-82-0
- Molecular formula:
- C13H26O2
- IUPAC Name:
- methyl laurate
- Details on test material:
- - Substance type: Lauric acid methyl ester
- Analytical purity: not specified
- Physical state: liquid, colourless
- Expiration date of the lot/batch: 1993-09-02
- 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
- Weight at study initiation: mean 2460 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 - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 24, 48 and 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 (Draize)
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 effect in any animal
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Remarks on result:
- other: no effect in any animal
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- 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 effect in any animal
- Irritant / corrosive response data:
- The observed conjunctival reactions (erythema and lacrimation) were only mild and disappeared completely within 72 h.
Any other information on results incl. tables
Table 1: Individual 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 |
|
1246 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1289 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
1302 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
A = Cornea Score
B = Iris Score
C = Erythema Score
D = Chemosis Score
L = Lacrimation
The test substance caused only slight erythema in 1 animal that were fully reversible within 72 h. According to DSD and CLP the test substance has not to classified.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information to rabbit eye in vivo Criteria used for interpretation of results: EU
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