Registration Dossier
Registration Dossier
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EC number: 250-800-0 | CAS number: 31778-10-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- AUG 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 404), performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Butyl 2-[[3-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-hydroxy-1-naphthyl]azo]benzoate
- EC Number:
- 250-800-0
- EC Name:
- Butyl 2-[[3-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-hydroxy-1-naphthyl]azo]benzoate
- Cas Number:
- 31778-10-6
- Molecular formula:
- C29H25N5O5
- IUPAC Name:
- butyl 2-({2-hydroxy-3-[(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)carbamoyl]-1-naphthyl}diazenyl)benzoate
- Test material form:
- solid: nanoform, no surface treatment
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratoires France, L'Arbresle, France
- Age at study initiation: 12 weeks (male), 14 weeks (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet (batch no. 85/05; provided by Provimi Kliba AG, CH-4303 Kaiseraugst); ad libitum
- Water: Community tap water from Füllinsdorf, ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g/animal
VEHICLE
- Amount applied: 0.5 mL/animal - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3 (1 male, 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: 4 cm x 4 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water
- Time after start of exposure: 4 h
SCORING SYSTEM:
Grading of Skin Reactions according to COMMISSION DIRECTIVE 2004/73/EC, APRIL 29, 2004
ERYTHEMA AND ESCHAR FORMATION
No erythema..................................................................................................................................0
Very slight erythema....................................................................................................................1
Well-defined erythema.................................................................................................................2
Moderate to severe erythema.....................................................................................................3
Severe erythema (beef redness) or eschar formation
(injuries in depth preventing erythema) reading.....................................................................4
OEDEMA FORMATION
No oedema......................................................................................................................................0
Very slight oedema (barely perceptible)....................................................................................1
Slight oedema (edges of area well-defined by definite raising).............................................2
Moderate oedema (edges raised approximately 1 mm)..........................................................3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure)...4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No edema
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No edema
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No erythema
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No erythema
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No erythema
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable since no effect
- Irritant / corrosive response data:
- Signs such as erythema could not be evaluated in all animals one hour after treatment due to presence of staining at the application site. No erythema was detectable at any later time point (score 0) and no edema were seen at any timepoint (score 0).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item did not reveal any irritation potential on the skin of rabbits, tested in this study according to OECD test guideline no. 404 and GLP conditions.
- Executive summary:
Skin irritation potential of the test item was assessed in rabbits according to OECD TG 404. The red coloured test item caused a marked red staining at the test site of all animals at the 1-hour reading. Slight red staining persisted throughout the whole study in all animals.
Signs such as erythema could not be evaluated in all animals one hour after treatment due to presence of staining at the application site. No erythema was detectable at any later time point in any animal (score 0) and no edema were seen at any timepoint in any animal (score 0).
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