Registration Dossier
Registration Dossier
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EC number: 213-903-1 | CAS number: 1064-48-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 2, 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to a method similiar to internationally accepted testing guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium 4-amino-5-hydroxy-3-(4-nitrophenylazo)-6-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 213-903-1
- EC Name:
- Sodium 4-amino-5-hydroxy-3-(4-nitrophenylazo)-6-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 1064-48-8
- Molecular formula:
- C22H16N6O9S2.2Na
- IUPAC Name:
- sodium 4-amino-5-hydroxy-3-(4-nitrophenylazo)-6-(phenylazo)naphthalene-2,7-disulphonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult mice
-Mean body weight at study initiation: c.a 23 g
- Diet (e.g. ad libitum): Altromin No.1324 DK pellets
- Water : fresh water ad libitum
- Food deprivation: test substance was applied after food deprivation of 18 h.
- Acclimation period: the animales were acclimatized in test cage 5 days prior to application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature was approx 22 °C
- Humidity (%): c.a. 50 %
- Photoperiod (hrs dark / hrs light): artificial lighting of the room varied every 12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: the product was provided as pure substance
- Purity:
MAXIMUM DOSE VOLUME APPLIED:
- Injectin volume: constant 20 cm3/kg - Doses:
- Single dose application : 5,000 mg/kg
- No. of animals per sex per dose:
- Ten mice were used
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes, withou any significant results
Other examinations performed:
- clinical signs n ot appliacble.
- Body weight: before application mean of 23.05
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animale died during the test duration
- Clinical signs:
- other: Not applicable
- Gross pathology:
- Without any significant finding
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to the CLP Regulation (EC n. 1272/2008)
- Conclusions:
- LD 50 >5000 mg/kg body weight
- Executive summary:
Method:
Acute oral toxcicity was determined by a single oral appication via stomach tube in male mice, according to the a guideline similar to OECD 423.
Observation:
There were no symptoms of intoxication.
Results:
An LD50 value of > 5000 mg/kg body weight was found.
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