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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:
1992
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

Constituent 1
Chemical structure
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: Solid, white
- Purity: Not specified
- Expiration date of the lot/batch: 17.09.1992
- Storage condition of test material: RT

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