Registration Dossier
Registration Dossier
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EC number: 817-761-7 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 - 30 Jun 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Adopted 24 February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Directive 92/96 EEC
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- The Department of Health of the Government of the United Kingdom, UK
Test material
- Reference substance name:
- Fatty acids, C18-unsatd., dimers, hydrogenated, reaction products with Phytosterol, Isooctadecan-1-ol, Hexadecan-1-ol, Octadecan-1-ol and Docosan-1-ol
- EC Number:
- 817-761-7
- Cas Number:
- 765293-81-0
- Molecular formula:
- Not applicable
- IUPAC Name:
- Fatty acids, C18-unsatd., dimers, hydrogenated, reaction products with Phytosterol, Isooctadecan-1-ol, Hexadecan-1-ol, Octadecan-1-ol and Docosan-1-ol
- Test material form:
- other: paste
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: David Percival Ltd., Moston, UK
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: Animals were individually housed in suspended metal cages.
- Diet: Certified Rabbit Diet (Code 5322) supplied by PMI Nutrition International (Nottingham, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL test item - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No corneal or iridial effects were noted during the study. Moderate conjunctival redness (score 2) was noted in all treated animals one hour after treatment with minimal conjunctival irritation (score 1) at the 24 h reading time point. All treated eyes appeared normal at the 48 h observation.
Any other information on results incl. tables
Table 1 Individual scores for ocular irritation
Rabbit number and sex |
1 Male |
2 Male |
3 Male |
||||||||||||||||||||||||||||
Time after Treatment |
1 hour |
24 hours |
48 hours |
72 hours |
Mean (24/ 48/72 h) |
1 hour |
24 hours |
48 hours |
72 hours |
Mean (24/ 48/72 h) |
1 hour |
24 hours |
48 hours |
72 hours |
Mean (24/ 48/72 h) |
||||||||||||||||
CORNEA Degree of opacity Area of cornea involved |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
||||||||||||||||
IRIS |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||||||||||||||
CONJUNCTIVAE Redness Chemosis Discharge |
2 1 2 |
1 0 1 |
0 0 0 |
0 0 0 |
0.33 0 0.33 |
2 1 2 |
1 0 1 |
0 0 0 |
0 0 0 |
0.33 0 0.33 |
2 1 2 |
1 0 1 |
0 0 0 |
0 0 0 |
0.33 0 0.33 |
||||||||||||||||
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.
- Conclusions:
- The test substance was considered to show no eye irritation.
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