Registration Dossier
Registration Dossier
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EC number: 269-133-1 | CAS number: 68187-89-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Acid chlorides, coco
- EC Number:
- 269-133-1
- EC Name:
- Acid chlorides, coco
- Cas Number:
- 68187-89-3
- Molecular formula:
- variable
- IUPAC Name:
- dodecanoyl chloride; tetradecanoyl chloride
- Reference substance name:
- Fatty acids, coco, chlorinated
- EC Number:
- 307-160-3
- EC Name:
- Fatty acids, coco, chlorinated
- Cas Number:
- 97553-06-5
- IUPAC Name:
- 97553-06-5
- Reference substance name:
- Cocoyl chloride
- IUPAC Name:
- Cocoyl chloride
- Reference substance name:
- 96/239
- IUPAC Name:
- 96/239
- Details on test material:
- - Name of test material (as cited in study report): Kokosfettsaeurechlorid)
- Batch No.: Vers. 148/U
- Physical state: clear liquid, yellowish
- Analytical purity: 99.5 % (by GC)
- Expiration date of the lot/batch: not reported
- Stability under test conditions: confirmed by the analytical report 98L00389 as stated in the 1st amendment
- Storage condition of test material: at room temperature under exclusion of moisture and oxygen (nitrogen atmosphere)
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach (Germany)
- Age at study initiation: young adult
- Weight at study initiation: 3.19 - 3.99 kg
- Housing: single
- Diet: Kliba Labordiaet 341 (Klingentalmuehle AG, Kaiseraugst, CH) ca. 130 g per day
- Water: tap water ca. 250 g per day
- Acclimatization: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/ 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 8 d
- Number of animals or in vitro replicates:
- 3 (two males, one female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: tap water
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: see table for details
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.4
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: see table for details
- Other effects:
- Discharge (Score 1 or 2) was observed within the first 24 h; see table for details
Any other information on results incl. tables
Exposition: |
24 h |
|
|
|
|
|
Animal |
Reading |
Opacity |
Iritis |
Redness |
Chemosis |
Symptoms |
1 |
1 h |
0 |
0 |
2 |
1 |
discharge score 2 |
2 |
1 h |
0 |
0 |
2 |
0 |
discharge score 1 |
3 |
1 h |
0 |
0 |
2 |
1 |
discharge score 1 |
1 |
24 h |
0 |
0 |
2 |
1 |
|
2 |
24 h |
0 |
0 |
2 |
0 |
discharge score 1 |
3 |
24 h |
0 |
0 |
1 |
0 |
|
1 |
48 h |
0 |
0 |
2 |
1 |
|
2 |
48 h |
0 |
0 |
1 |
0 |
|
3 |
48 h |
0 |
0 |
1 |
0 |
|
1 |
72 h |
0 |
0 |
2 |
1 |
loss of hair in the margines of eyelids |
2 |
72 h |
0 |
0 |
0 |
0 |
|
3 |
72 h |
0 |
0 |
1 |
1 |
|
1 |
8 d |
0 |
0 |
0 |
0 |
loss of hair in the margines of eyelids |
2 |
8 d |
0 |
0 |
0 |
0 |
|
3 |
8 d |
0 |
0 |
0 |
0 |
|
mean |
24 - 72 h |
0.00 |
0.00 |
1.33 |
0.44 |
|
Applicant's summary and conclusion
- Executive summary:
The study was performed comparable to OECD guideline 405 and GLP requirements and is relable without restrictions. 0.1 mL of the unchanged test substance was instilled to the eyes of three rabbits and washed out after 24 h. Effects on corneal opacity and the iris were not observed, the scores for conjuctivae redness and chemosis were 1.3 and 0.4, respectively (mean of the 24, 48 and 72 h readings).
Conclusion
Following the conditions of the test, cocoyl chloride has not to be considered as irritating to the eyes.
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