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:
other: Well documented study report, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): DEA, by-products
- no further data

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Germany
- Weight at study initiation: 2.24, 2.77, 3.28 kg
- Housing: individual, stainless steel cages without beddings
- Diet Ovator Solikanin, Muskator-Werke, Düsseldorf, Germany; 130 g /day
- Water Tap water 250 ml/day
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): unchanged
Duration of treatment / exposure:
not applicable, because test substance remained in the eye and was not washed out
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): none


SCORING SYSTEM: according to OECD Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
1-3
Time point:
other: 24.48,72 hrs
Score:
2.55
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: cornea area
Basis:
mean
Remarks:
1-3
Time point:
other: 24.48,72 hrs
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
1-3
Time point:
other: 24.48,72 hrs
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
1-6
Time point:
other: 24.48,72 hrs
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
1-3
Time point:
other: 24.48,72 hrs
Score:
2.89
Max. score:
3
Reversibility:
not reversible

Any other information on results incl. tables

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

op

ar

red

ch

di

1 h

1

2

4

2

3

2

3

PC

2

2

4

2

3

3

2

PC

3

1

4

1

3

2

3

PC

24 h

1

2

4

2

3

3

3

E, PC

2

2

4

2

3

3

2

E, PC

3

2

4

2

3

2

2

E, Pv, Na

48 h

1

2

4

2

3

3

3

SI/Na

2

2

4

2

3

3

2

E, PC, Na

3

2

4

2

3

3

2

E, PC, Na

72 h

1

4

4

2

3

3

3

S1/Na

2

4

4

2

3

3

3

E, Na

3

3

4

2

3

3

3

E, Pv, Na

Mean

24 -72 h

1

2.66

4

2

3

3

3

 

2

2.66

4

2

3

3

2.33

 

3

2.33

4

2

3

2.66

2.33

 

Mean

24-72 h

1-3

2.55

4

2

3

2.89

2.55

 

 

Symbols:

S1: reading not possible due to pus formation

E: pus formation

PC: Pupil contracted

Na: scars at the eyelids

Applicant's summary and conclusion