Registration Dossier
Registration Dossier
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EC number: 203-845-5 | CAS number: 111-20-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 (Acute Dermal 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
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system 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: 2-3 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): automatic watering valve system
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C ± 2
- Humidity (%): 55 % ± 10
- Air changes (per hr): 10-20 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume or weight with unit): 0.5 g (6 cm²) - Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours
- Observation period:
- Immediately and 72 hours after the 3-minute and the 1-hour exposure period in the first rabbit and at 1,24,48 and 72 hours after the 4-hours exposure period (all rabbits).
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Table 1: Dermal erythema reactions after four hours of exposure.
Exp. Period 4 h Erythema and Eschar |
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 |
Table 2: Dermal edema reactions after four hours of exposure.
Exp. Period 4 h Edema |
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 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Neither mortality nor adverse general clinical modifications were seen during the study.
The test substance administered to rabbits by the dermal route, is to be considered "NON IRRITANT" for the skin.
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