Registration Dossier
Registration Dossier
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EC number: 223-460-6 | CAS number: 3905-19-9
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:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- (1987)
- GLP compliance:
- no
- Remarks:
- GLP was not mandatory when study was conducted
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
- EC Number:
- 223-460-6
- EC Name:
- N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
- Cas Number:
- 3905-19-9
- Molecular formula:
- C40H24Cl4N6O4
- IUPAC Name:
- N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
- Details on test material:
- Physical state: no data
Analytical purity: no data
Impurities (identity and concentrations): no data
Constituent 1
- Specific details on test material used for the study:
- Physical state: no data
Analytical purity: no data
Impurities (identity and concentrations): no data
Test animals
- Species:
- rat
- Strain:
- other: Tif RAI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: random bred of the TIF RAI strain
- Age at study initiation: young (no further information given)
- Weight at study initiation: 145- 170 g
- Fasting period before study: overnight
- Housing: groups of 5 in macrolon cages
- Diet: Nafag (ad libitum)
- Water: ad libitum
- 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:
- other: sesam oil
- Details on oral exposure:
- Test substance was suspended in sesam oil at following concentrations 10% for 1000 mg/kg bw
30% for 3000 mg/kg bw and 25% for 10000 mg/kg bw and 15000 mg/kg bw - Doses:
- 1000, 3000, 10000, 15000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 15 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed
- Mortality:
- no mortality
- Clinical signs:
- other: lowest dose (1000 mg/kg): hyperreflexia lasting >6 hours. After 24 hours no symptoms other doses (3000, 10000, 15000 mg/kg): same clinical signs as at lowest dose, additionally reduction in spontanous motility, ataxia, irregular respiration
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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