Registration Dossier
Registration Dossier
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EC number: 241-481-9 | CAS number: 17464-91-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan/Feb 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: US Federal Register 38, No. 187, § 1500.41
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2'-[[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]-3-chlorophenyl]imino]bisethanol
- EC Number:
- 241-481-9
- EC Name:
- 2,2'-[[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]-3-chlorophenyl]imino]bisethanol
- Cas Number:
- 17464-91-4
- Molecular formula:
- C16H15BrCl2N4O4
- IUPAC Name:
- 2,2'-[[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]-3-chlorophenyl]imino]bisethanol
- Test material form:
- liquid
- Details on test material:
- Disperse Brown 4
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, 6050 Offenbach/Main, Germany
- Housing: One animal per cage, cages: stainless steel with wire inlays, base area 40 x 51 cm
- Diet (e.g. ad libitum): ad libitum, ca. 130 g per animal per day, diet: Ovator Solikanin 4 MM, Muskator Werke, Düsseldorf, Germany
- Water (e.g. ad libitum): ad libitum, 250 mL per animal per day, Monday-Friday: VE-water, Saturday-Sunday: tap water
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 °C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 8 days
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm; upper third of the back or flank
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
30-60 min after exposure period and 24, 48 and 8 days after start of application
SCORING SYSTEM:
- Method of calculation: Scoring according to the Method of Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance was not found to be irritating on rabbit skin. The substance is not classifiable according to CLP criteria.
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