Registration Dossier
Registration Dossier
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EC number: 203-845-5 | CAS number: 111-20-6
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sebacic acid
- EC Number:
- 203-845-5
- EC Name:
- Sebacic acid
- Cas Number:
- 111-20-6
- Molecular formula:
- C10H18O4
- IUPAC Name:
- sebacic acid
- Test material form:
- solid
- Details on test material:
- - Name of test material: Acido Sebacico
- Physical state: white solid
- Analytical purity: 100 %
- Lot/batch No.: 981105
- Storage condition of test material: at room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Conelli S.n. c. Arona (Italy)
- Age at study initiation: about 2-3 months old
- Weight at study initiation: about 2-3 kg
- Diet: ad libitum
- Water: automatic watering valve system
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C ± 2
- Humidity (%): 55 % ± 10
- Air changes (per hr): 15-20 air changes
- 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 g - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effect
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
Any other information on results incl. tables
Table 1: Eye reaction redness observed during the study.
Conjunctivae: Redness |
Animal # |
||
Obs. Made at |
56M |
58M |
59M |
60 minutes |
2 |
2 |
2 |
24 hours |
2 |
2 |
2 |
48 hours |
1 |
2 |
2 |
72 hours |
0 |
1 |
1 |
7 days |
0 |
0 |
0 |
Table 2: Eye swelling reactions observed during the study.
Conjunctivae: Chemosis |
Animal # |
||
Obs. Made at |
56M |
58M |
59M |
60 minutes |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
48 hours |
0 |
0 |
0 |
72 hours |
0 |
0 |
0 |
7 days |
0 |
0 |
0 |
Table 3: Opacity reactions observed during the course of the study.
Cornea: Opacity |
Animal # |
||
Obs. Made at |
56M |
58M |
59M |
60 minutes |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
48 hours |
0 |
0 |
0 |
72 hours |
0 |
0 |
0 |
7 days |
0 |
0 |
0 |
Table 4: Effects on the iris observed during the course of the study.
Iris: Iritis |
Animal # |
||
Obs. Made at |
56M |
58M |
59M |
60 minutes |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
48 hours |
0 |
0 |
0 |
72 hours |
0 |
0 |
0 |
7 days |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance administered to rabbits as a single ocular application, is to be considered "NON IRRITANT" for the eye.
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