Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
July 03rd, 1989 - July 06th, 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. Limited details on study substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: Limited details on study substance
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: liquid, yellow

Test animals / tissue source

Species:
rabbit
Strain:
other: Kleinrusse, Chbb
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Thomae, Biberach, Deutschland
- Age at study initiation: 6 months
- Weight at study initiation: 2550 g
- Diet: Altromin 2023 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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
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
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, eye was rinsed with water
- Time after start of exposure: 24 h


SCORING SYSTEM: According to 84/449/EWG


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all three animals
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: No effect
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all three animals
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: No effect
Irritation parameter:
conjunctivae score
Basis:
animal: #1195
Time point:
other: 24 h, 48 h and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of animals #1192 and #1193
Time point:
other: 24 h, 48 h and 72 h
Score:
0
Max. score:
3
Reversibility:
other: No effect
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
mean of all three animals
Time point:
other: 24 h, 48 h and 72 h
Score:
0
Max. score:
4
Reversibility:
other: No effect

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

1192

0

0

0

0

2

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

1193

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1195

0

0

1

0

2

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

A = Corneal 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