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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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

Constituent 1
Reference substance name:
Amides, C16-C18 (even) , N,N'-ethylenebis
EC Number:
931-299-4
Cas Number:
68390-94-3
Molecular formula:
not available UVCB
IUPAC Name:
Amides, C16-C18 (even) , N,N'-ethylenebis
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: 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):
24 h
Reading time points: 1, 7, 24, 48 and 72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: physiol. saline
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0.17
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: observation period not sufficient to assess full reversibility
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0.72
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: observation period not sufficient to assess full reversibility
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
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

Conjunctiva 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

Conjunctiva 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

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified