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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (only 72h observation time, no informations on full reversibility)
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only 72h observation time, no informations on full reversibility
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Hoechst-Wachs C Mikropulver (Bis-stearoyl/palmitoyl-ethylendiamid)
- Molecular formula: C38H76N2O2
- Molecular weight: 593
- Physical state: yellowish-white powder
- Analytical purity: technical
- Impurities (identity and concentrations): non-reacted stearic acid, concentration not specified; ethylene diamine in ppm-range
- Composition of test material, percentage of components: 60% Bis-stearoyl-ethylene diamide, 40% Bis-palmitoyl ethylene diamide

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Own breeding
- Weight at study initiation: 2.02 - 2.59 kg
- Housing: Separated in single cages
- Diet: Standard diet ERKA 8300 (Robert Koch oHG, Hamm), ad libitum
- Water: Ad libitum

Test system

Vehicle:
other: Polyethylene glycol 400
Controls:
other: right eye served as untreated control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg, moistened with 0.4 ml vehicle

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.4 ml
Duration of treatment / exposure:
24 h
Observation period (in vivo):
Examinations after 1, 7, 24, 48 and 72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiol. saline
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand lens, additionally at 48 and 72 h timepoints: one drop of fluorescein 0.01 %

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.17
Max. score:
4
Reversibility:
not fully reversible within: 72h (end of observation period)
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.72
Max. score:
3
Reversibility:
not fully reversible within: 72h (end of observation time)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
Although there is slight redness and corneal opacity left in 1/6 animals after 72 hours, the decrease of the scores over the observation time and the slight characteristics of the observations make it reasonable to anticipate full reversibility after a slightly longer observation period.

Any other information on results incl. tables

Table 1: Eye irritation scores after 1 and 7 h

 

1 h

7 h

Rabbit No.

1

2

3

4

5

6

1

2

3

4

5

6

Cornea score

0

1

0

0

0

0

0

0

1

0

0

0

Iris score

0

0

0

0

0

0

0

0

0

0

0

0

Cojunctiva score

2

2

2

2

2

2

2

2

2

2

2

1

Chemosis score

2

2

2

2

2

2

1

1

1

1

1

1

Discharge score

3

3

3

3

2

3

2

1

1

1

0

1

Table 2: Eye irritation scores after 24, 48 and 72 h

 

24 h

48 h

72 h

Rabbit No.

1

2

3

4

5

6

1

2

3

4

5

6

1

2

3

4

5

6

Cornea score

0

0

1

0

0

0

0

0

1

0

0

0

0

0

1

0

0

0

Iris score

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Cojunctiva score

1

1

1

2

2

0

1

1

1

1

1

0

0

0

1

0

0

0

Chemosis score

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Discharge score

1

1

2

1

0

1

0

0

0

0

0

0

0

0

0

0

0

0

Although there is slight redness and corneal opacity left in one animal after 72h, the decrease of the scores over the observation time and the slight characteristics of the observations make it reasonable to anticipate full reversibility after a slightly longer observation period. Therefore the substance does not have to be classified according to the criteria of Regulation (EC) 1272/2008 and Directive 67/548/EEC.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information