Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 21st, 1991 - May 24th, 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study (OECD)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: No data on vehicle given
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Fatty acid C16-18, ester with pentaerythrit
- Physical state: Solid, white
- Analytical purity: 99%
- Lot/batch No.: 51531022
- Stability under test conditions: 18 months
- Storage condition of test material: 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, Germany
- Age at study initiation: 4 months
- Weight at study initiation: approx.2090 g
- Housing: single holding in cage
- Diet (e.g. ad libitum): ad libitum (Ssniff rabbit diet K4
- Water (e.g. ad libitum):ad libitum



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, untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (bump-volume)

VEHICLE
- Amount(s) applied (volume or weight with unit): No Data
Duration of treatment / exposure:
single application, 24 h
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eye was thoroughly rinsed with warm water.
- Time after start of exposure: 24 h


SCORING SYSTEM: According to Council Directive 84/449/EEC

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all tested animals and readings at
Time point:
other: 24 h, 48 h and 72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects
Remarks on result:
other: No reactions at any time point in any tested animal
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all tested animals and readings at
Time point:
other: 24 h, 48 h and 72 h
Score:
0
Max. score:
2
Reversibility:
other: No effects
Remarks on result:
other: No reactions at any time point in any tested animal
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of all tested animals and readings at
Time point:
other: 24 h, 48 h and 72 h
Score:
0
Max. score:
3
Reversibility:
other: No effects
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all tested animals and readings at
Time point:
other: 24 h, 48 h and 72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects
Irritant / corrosive response data:
No effects were observed except a very mild and reversible exsudation reaction in one out of three animals 24 h after application.

Any other information on results incl. tables

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

1237

0

0

0

0

1

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

1238

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1240

0

0

0

0

0

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

E = Exsudation Score

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU