Registration Dossier
Registration Dossier
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EC number: 226-106-9 | CAS number: 5280-78-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- 30 mL test preparation per kg bw; 8 days observation period, individual test results missing, no data on necropsy
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- N,N'-(2-chloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
- EC Number:
- 226-106-9
- EC Name:
- N,N'-(2-chloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
- Cas Number:
- 5280-78-4
- Molecular formula:
- C40H23Cl5N6O4
- IUPAC Name:
- N,N'-(2-chloro-1,4-phenylene)bis{4-[(2,5-dichlorophenyl)diazenyl]-3-hydroxy-2-naphthamide}
- Test material form:
- not specified
- Details on test material:
- - Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CFE (RAC; SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder; random breed
- Age at study initiation: young
- Weight at study initiation: 107-147 g
- Housing: in groups of 5 in macrolon cages (size 3)
- Diet (e.g. ad libitum): Nafag, ad lib.
- Water (e.g. ad libitum): drinking water, ad lib.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-1
- Humidity (%): 55+-5
- Photoperiod (hrs dark / hrs light): 10/14
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- aqueous suspension with 0.5% CMC
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25/ 33.3%
MAXIMUM DOSE VOLUME APPLIED: 30 mL/kg bw - Doses:
- 5000 and 10000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 8 days
- Frequency of observations and weighing: observations: no data; weighing at day 0 and day 8
- Necropsy of survivors performed: not reported
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: only unspecific clinical signs observed
- Mortality:
- not observed
- Clinical signs:
- other: 5000 mg/kg bw: piloerection 10000 mg/kg bw: ataxia, sedation, piloerection, inhibition of spontaneous motility, red stained urine and feces
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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