Registration Dossier
Registration Dossier
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EC number: 255-485-3 | CAS number: 41669-30-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 - 30 Jan 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study with acceptable restrictions. Lack of detail on test material.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1987
- Deviations:
- yes
- Remarks:
- lack of detail on test material
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isooctadecyl isooctadecanoate
- EC Number:
- 255-485-3
- EC Name:
- Isooctadecyl isooctadecanoate
- Cas Number:
- 41669-30-1
- Molecular formula:
- C36H72O2
- IUPAC Name:
- 2-methylheptadecyl 3-methylheptadecanoate
- Details on test material:
- - Name of test material (as cited in study report): [only trade name given]
- Physical state: liquid
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Des Feuilletas, Campet Lamolere, France
- Age at study initiation: no data
- Weight at study initiation: 2 ± 0.2 kg
- Housing: the animals were housed in individual stainless steel cages (61 x 46 x 34 cm) with a grid floor. The door of each cage was equipped with a feeding device and a 1000 mL drinking bottle.
- Diet: Feed UAR 112, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated left eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- single eye instillation without washing
- Observation period (in vivo):
- 72 hours
Reading time points: 1, 24, 48 and 72 h after instillation - Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- other: mean of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- other: mean of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- A slight redness (conjunctivae) was observed in 1/3 animals at the 24 h reading time point, which was fully reversible within 48 hours. No corneal or iridial effects were noted at any observation time point during the study. No further local or systemic toxic effects were observed. The mean cornea, iris, and chemosis scores after 24, 48, and 72 h were 0 for all 3 animals. The mean conjunctivae score after 24, 48 and 72 h of one animal was 0.33; however the other two was 0
Any other information on results incl. tables
Table 1. Results of eye irritation study
Rabbit #
|
Time [h] |
conjunctivae
|
iris
|
cornea
|
|
Redness |
Swelling |
||||
1 |
1 |
0 |
1 |
0 |
|
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
Average |
0 |
0 |
0 |
0 |
|
2 |
1 |
2 |
1 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
Average |
0 |
0 |
0 |
0 |
|
3 |
1 |
1 |
1 |
0 |
0 |
24 |
0 |
1 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
Average |
0 |
0.33 |
0 |
0 |
|
Average score |
1 |
1.00 |
1.00 |
0.00 |
0.00 |
24 |
0.00 |
0.33 |
0.00 |
0.00 |
|
48 |
0.00 |
0.00 |
0.00 |
0.00 |
|
72 |
0.00 |
0.00 |
0.00 |
0.00 |
|
24+48+72 |
0.00 |
0.11 |
0.00 |
0.00 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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