Registration Dossier
Registration Dossier
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EC number: 228-768-4 | CAS number: 6358-31-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 Jan - 11 Apr 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The test was performed in accordance with OECD and GLP guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide
- EC Number:
- 228-768-4
- EC Name:
- 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide
- Cas Number:
- 6358-31-2
- Molecular formula:
- C18H18N4O6
- IUPAC Name:
- 2-[(2-methoxy-4-nitrophenyl)diazenyl]-N-(2-methoxyphenyl)-3-oxobutanamide
- Test material form:
- solid: nanoform, no surface treatment
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxicology Department Rallis Research Centre, Bangalore, India
- Age at study initiation: 13 weeks
- Weight at study initiation: Males 281-316 g, females 179-191 g
- Fasting period before study: 16-18 hours
- Housing: individually in suspended stainless steel wire mesh cages with stainless steel top grill
- Diet (e.g. ad libitum): Ssniff rats/mice food, Ssniff Spezialdiäten GmbH, Soest, Germany, ad libitum
- Water (e.g. ad libitum): purified deep bore well water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24 °C
- Humidity (%): 30-70 % relative humidity
- Air changes (per hr): adequate fresh air supply
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: refined ground nut oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: ground nut oil gave a suitable suspension of the test material
- Lot/batch no. (if required): not stated
- Purity: not stated
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kig - Doses:
- 2000 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
- Frequency of observations and weighing: four times on test day one and once daily during days 2-15, body weights were recoreded on days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy - Statistics:
- not applicable for limit test
Results and discussion
- Preliminary study:
- In a pretest, the test item was given at 2000 mg/kg bw to 2 male and 2 female rats. No toxic signs and pre-terminal deaths occurred.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No pre-terminal deaths occurred.
- Clinical signs:
- other: No clinical signs were observed. The faeces of all rats had test item stain during days 2 and 3, which disappeared completely from day 4 onwards.
- Gross pathology:
- No abnormalities were observed.
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- LD50 >2000 mg/kg bw Criteria used for interpretation of results: other: EU DSD and EU CLP
- Conclusions:
- 67/548/EEC: Acute oral toxicity: no classification warranted
1272/2008/EC: Acute oral toxicity: no classification warranted
No death were seen in an OECD and GLP compliant acute oral toxicity study in male and female Wistar rats after single oral application of 2000 mg/kg of Hansa Brilliant Yellow 5GX IN (Pigment Yellow 74).
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