Registration Dossier
Registration Dossier
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EC number: 444-370-5 | CAS number: 669005-94-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-01-07 to 2003-01-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline and GLP-compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- RCC Ltd.
Test material
- Reference substance name:
- -
- EC Number:
- 444-370-5
- EC Name:
- -
- Cas Number:
- 669005-94-1
- Molecular formula:
- C28 H23 F3 N6
- IUPAC Name:
- 4-methyl-2,6-bis[(4-methylphenyl)amino]-5-{2-[2-(trifluoromethyl)phenyl]diazen-1-yl}pyridine-3-carbonitrile
- Details on test material:
- - Description: Orange solid
- Stability of test item: Stable under storage conditions
- Expiry date: 01-OCT-2005
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes; F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 11 weeks (males); 12 weeks (females)
- Housing: Induvidually, in stainless steel cages
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet, ad libitum
- Water: Community tap water from Füllinsdorf, ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70%
- Air changes: 10-15 air changes per hour
- Photoperiod: light cycle of 12 hours light and 12 hours dark
In-Life-phase: 07-JAN-2003 to 28-JAN-2003
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Concentration (if solution): 1 %
VEHICLE
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- The duration of treatment was four hours.
- Observation period:
- The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 100 cm2 (10 cm x 10 cm)
- Type of wrap if used: gauze patch covered with a semiocclusive dressing
REMOVAL OF TEST SUBSTANCE
After the 4 hour treatment period, the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.
SCORING SYSTEM: according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24,48,72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable, no effects
- Remarks on result:
- other: The erythema was not assessable in all animals at the 1-hour reading due the marked red staining produced by the test item
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24,48,72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable, no effects
- Irritant / corrosive response data:
- Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.
- Other effects:
- - No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
- Marked red staining by the test item of the treated skin was observed in all animals at the 1-hour reading. Light red staining was still present in all animals up to 14 days after treatment, the end of the observation time.
- The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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