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EC number: 203-756-1 | CAS number: 110-31-6
Eye irritation
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:
- 1 981
- 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
- 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
Constituent 1
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
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