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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 May - 07 May 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 1987
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): methyl hexonate
- Substance type: Fatty acid methyl ester
- Physical state: liquid, colourless
- Purity: > 98%
- Lot/batch No.: 1291191
- Expiration date of the lot/batch: 24.06.1994
- Storage condition of test material: at room temperature

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: approx. 2620 g
- Housing: individually
- Diet: Ssniff rabbit diet K4, ad libitum
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 70
- Photoperiod (hrs dark / hrs light): 12/12
- Air changes: at least 8/h

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
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
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): water
- Time after start of exposure: 24 h

SCORING SYSTEM
Draize scoring system was used

TOOL USED TO ASSESS SCORE:
Slit lamp microscope

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 h, 48 h and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: none of the animals showed corneal reaction
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: none of the animals showed iris reaction
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: redness graded 1 was seen at reading points 1, 24 and 48 hour
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: man over 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: no effect
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: redness graded 1 was seen at reading time points 1 and 24 hour
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: none of the 3 animals showed chemosis
Irritant / corrosive response data:
One animal showed slight conjunctival redness of grade 1 at reading time points 1, 24 and 48 hour. A further animal showed the same finding at 1 and 24 hour; in this animal, redness at 1 hour was further accompanied by lacrimation graded 2. The third animal showed no signs of irritation at all.

Any other information on results incl. tables

Table 1: Results of eye irritation study for all reading time points

Animal

Hours after application

1

24

48

72

A

B

C

D

E

A

B

C

D

E

A

B

C

D

E

A

B

C

D

E

1323

0

0

1

0

0

0

0

1

0

0

0

0

1

0

0

0

0

0

0

0

1261

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1318

0

0

1

0

2

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

A = Corneal Reaction

B = Irritational Reaction

C = Erythema

D = Chemosis

E = Exsudation

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