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Registration Dossier
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EC number: 931-299-4 | CAS number: 68390-94-3
Eye irritation
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:
- comparable to guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Analytical purity of test substance not specified, occlusive dressing according to former guideline, 24 h exposure time, test substance was not removed after exposure
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Own breeding
- Weight at study initiation: 2.16 - 2.45 kg
- Housing: Separated in single cages
- Diet: Standard diet ERKA 8300 (Robert Koch oHG, Hamm, Germany), ad libitum
- Water: ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- other: 6 x 3 cm, one half shaved the other additionally abraded
- Vehicle:
- other: Polyethylenglycol 400
- Controls:
- not specified
- Amount / concentration applied:
- 500 mg in 1.2 mL vehicle on 2.5 x 2.5 cm
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration: 500 mg moistened with 1.2 ml polyethyleneglycol 400
VEHICLE
- Amount(s) applied (volume or weight with unit): 1.2 ml - Duration of treatment / exposure:
- 24 h
- Observation period:
- Examinations after 24, 48 and 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: shaved flank
- Type of wrap if used: Moistened test material was applied to 2.5 x 2.5 cm cellulose pads from Hansamed, the pads were fixed to the prepared application site and covered with an indifferent, impermeable polyethylene film (6 - 8 cm width). Subsequently, the whole trunk of the animals was wrapped with an elastic polyurethan warp bandage (permanent bandage K, Lohmann) left in place for 24 h.
REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: intact skin
- Irritant / corrosive response data:
- No erythema was observed in abraded skin, either. Edema of grade 1 was observed in 4/6 animals in abraded skin after 24 h which was fully reversible after 48 h.
- Other effects:
- No mortality occurred. There were no clinical signs of systemic toxicity from the dermal exposure.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Executive summary:
The test substance is not irritating and does not have to be classified according to the criteria of Regulation (EC) No. 1272/2008.
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 72 h observation time, no informations on full reversibility
- GLP compliance:
- no
Test material
- Reference substance name:
- N,N'-ethylenedi(stearamide)
- EC Number:
- 203-755-6
- EC Name:
- N,N'-ethylenedi(stearamide)
- Cas Number:
- 110-30-5
- Molecular formula:
- C38H76N2O2
- IUPAC Name:
- N,N'-ethane-1,2-diyldioctadecanamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
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, Germany), 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 applied: 100 mg, moistened with 0.4 mL vehicle
VEHICLE
- Amount applied: 0.4 mL - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 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
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:
- animal: #1, #2, #4 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h (end of observation period)
- Irritation parameter:
- iris score
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h (end of observation period)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #4, #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 to #6
- 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 |
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 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Executive summary:
Although there is slight redness and corneal opacity left in one animal after 72 h, 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) No. 1272/2008.
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