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Registration Dossier
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EC number: 213-834-7 | CAS number: 1025-15-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 Apr - 19 May 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit und Soziales, Hamburg, Germany
Test material
- Reference substance name:
- 1,3,5-triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- EC Number:
- 213-834-7
- EC Name:
- 1,3,5-triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- Cas Number:
- 1025-15-6
- Molecular formula:
- C12H15N3O3
- IUPAC Name:
- tris(prop-2-en-1-yl)-1,3,5-triazinane-2,4,6-trione
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 4 months
- Weight at study initiation: 2.1-2.5 kg
- Housing: during the acclimatisation period and after the 4-hour period in restrainers (allowed free movement of the head but prevented a complete body turn), the animals were kept singly in cages (425 mm x 600 mm x 380 mm)
- Diet: ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, Soest, Germany); available ad libitum before and after the exposure period
- Water: drinking water, ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
-according to guideline
IN-LIFE DATES: From: 28 Apr 2003 To: 19 May 2003
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- up to 5 days
Reading time points: 1, 24, 48 and 72 h, 4 and 5 days - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the dorsal area of the trunk
- Type of wrap if used: The treated skin was covered with a gauze patch, which was held in contact with the skin by means of a semi-occlusive dressing for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- no residual test substance had to be removed
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- Erythema of grade 1 was observed in one animal at the reading time points 24, 48 and 72 h and 4 days after patch removal. No further signs of skin irritation were noted in any of the animals.
- Other effects:
- There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this skin irritation study in the rabbit, the test item did not cause any irritant effect to the skin.
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