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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
18 Dec 1981 - 25 Jan 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions; due to a complete lack of reactions the observation period was stopped after 24 h; analytical purity data on test substance was not given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
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:
Due to a complete lack of reactions the observation was stopped after 24 h; lack of details on test substance
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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:
- Name of test material (as cited in study report): Methyl dodecanoate
- Physical state: amber liquid
- Analytical purity: no data
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Isaacs lab stock
- Weight at study initiation: >1500 g
- Acclimation period: at least 7 days

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served for control
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):
24h (observation period was terminated after 24 hours due to lack of effects)
Number of animals or in vitro replicates:
3 per treatment (rinsed/not rinsed)
Details on study design:
REMOVAL OF TEST SUBSTANCE: Rinsing with tap water

SCORING SYSTEM: according to Draize scoring system (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: rinsed
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: 24 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: rinsed
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: 24 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: rinsed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: rinsed
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: 24 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: 24 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: not rinsed
Irritant / corrosive response data:
No effects indicating eye irritation were observed at all.

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