Registration Dossier
Registration Dossier
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EC number: 213-208-3 | CAS number: 930-02-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-01-19 to 1988-03-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study. No GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- May 12, 1981
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 1-(vinyloxy)octadecane
- EC Number:
- 213-208-3
- EC Name:
- 1-(vinyloxy)octadecane
- Cas Number:
- 930-02-9
- Molecular formula:
- C20H40O
- IUPAC Name:
- 1-(ethenyloxy)octadecane
- Test material form:
- other: colourless liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main; Germany
- Weight at study initiation: Male: 2.90 kg; Females: 3.05 kg;
- Housing: single animals in stainless steel cages with wire mesh walk floors; floor area: 40 x 51 cm
- Diet: Kliba 341, 4 mm; Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland; abt. 130 g per animal per day
- Water: abt. 250 mL tap water per animal per day
- Acclimation period: at least 8 days before beginning of the study; same housing conditions as during the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Humidity (%):30 -70
- Photoperiod (hrs dark / hrs light): !2 h/12 h (6.00 - 18 .00 hours/18 .00 - 6 .00 hours)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- undiluted;
Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 15 days
- Number of animals:
- 3 (1 male, 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: four layers of absorbent gauze and porous bandage
REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water 1:1
- Time after start of exposure: 4 h
SCORING SYSTEM:
Calculation of the mean according to 83/467/EEC criteria of July 29th, 1983; for calculation of the means of erythema and edema only the readings of 24, 48, and 72 hours are used
EVALUATION OF ERYTHEMA (R) AND EDEMA (ED) :
0 = NONE
1 = VERY SLIGHT
2 = WELL-DEFINED
3 = MODERATE TO SEVERE
4 = SEVERE TO VERY SEVERE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (0344)
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (0342)
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (0306)
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (0344)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (0342)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (0306)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Irritant / corrosive response data:
- Not irritating
- Other effects:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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