Registration Dossier
Registration Dossier
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EC number: 247-384-8 | CAS number: 25973-55-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study but with restrictions (no data on test substance purity and no GLP) .
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 1981
- Deviations:
- yes
- Remarks:
- (no data on test substance purity)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 2002
- Deviations:
- yes
- Remarks:
- no weight-of-evidence analysis for performing an in vivo study, no data on test substance purity, no justification for choice of vehicle
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol
- EC Number:
- 247-384-8
- EC Name:
- 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol
- Cas Number:
- 25973-55-1
- Molecular formula:
- C22H29N3O
- IUPAC Name:
- 2-(2H-benzotriazol-2-yl)-4,6-bis(1,1-dimethylpropyl)phenol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2.2 - 2.3 kg
- Housing: individually in metal cages, identified with individually numbered ear tags
- Diet (ad libitum): standard rabbit pellet (Nafag No. 814, Gossau, Switzerland)
- Water (ad libitum): fresh
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): constant 20 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: distilled water containing 0.5 % carboxymethylcellulose and 0.1 % polysorbate 80 (prepared by Pharmaceuticals Division, CIBA-Geigy Ltd.)
- Controls:
- other: untreated contralateral flank of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 days
- Number of animals:
- 3 male animals
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² of the flank
- Type of wrap if used: Gauze patch moistened with the vehicle ( and the test substance on the treatment flank). It was loosely covered with aluminium foil (36 cm²), held in place by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg)
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- mean out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- mean out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- One hour after exposure 2 out of 3 animals developed erythema grade 1, one animal erythema grade 2.
One hour after exposure one animal out of 3 developed edema grade 1, one animal edema grade 2. - Other effects:
- Body weight gains were as expected.
Any other information on results incl. tables
Tab. 1: Individual Skin reaction score after treatment with the test substance
(CF = control flank, TF = test flank, M = male)
animal no. |
erythema |
edema |
||||
7 /M |
8 /M |
9 /M |
7 /M |
8 /M |
9 /M |
|
CF/TF |
CF/TF |
CF/TF |
CF/TF |
CF/TF |
CF/TF |
|
after 1 hr. |
0/1 |
0/1 |
0/2 |
0/0 |
0/1 |
0/2 |
after 24 hrs. |
0/0 |
0/1 |
0/1 |
0/0 |
0/0 |
0/0 |
after 48 hrs. |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
after 72 hrs. |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
mean 24-72 hrs. |
0/0 |
0/0.33 |
0/0.33 |
0/0 |
0/0 |
0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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