Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
BASF-Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: No. XXI/170


Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Mean Weight at study initiation: 2.45 kg
- Diet: Altromin MS (Altroge, Germany) ad libitum
- Water: ad libitum


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: concurrent saline
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 m³
- Concentration: concentrated
Duration of treatment / exposure:
not applicable (substance was not washed out)
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2 (m/f)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: none

Readings at 10 min, 1 and 24 hrs, 3 and 8 days

SCORING SYSTEM: initial scoring system was converted into Draize-scores

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 24 hours
Score:
1
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 8 days
Score:
0
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours, 8 days
Score:
0
Reversibility:
fully reversible within: 8 days

Any other information on results incl. tables

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

op

ar

red

ch

di

1 h

1

-

-

-

1

1

-

 

2

-

-

-

1

1

-

 

24 h

1

-

-

-

1

0

-

 

2

-

-

-

1

0

-

 

48 h

1

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

72 h

1

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

8 d

1

-

-

-

0

0

-

 

2

-

-

-

0

0

-

 

Mean

24 -72 h

1

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

Mean

24-72 h

1-2

 

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met