Registration Dossier
Registration Dossier
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EC number: 273-386-3 | CAS number: 68959-00-2
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
- Principles of method if other than guideline:
- Acute oral toxicity in by gavage in rats.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Acid Orange 116
- IUPAC Name:
- Acid Orange 116
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9 - 14 weeks
- Weight at study initiation: average initial weight 173 g
- Housing: groups of 5
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1.5 °C
- Humidity: 60 ± 5 %
- Photoperiod: 12 h light/dark rhytm
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- - Amount of vehicle (if gavage): 30 ml/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- On the day of application, animals were inspected twice, over the following 14-day observation period twice a day (once on weekends and holidays), and type, onset, duration and intensity of clinical symptoms were recorded and any dead animals removed.
At application and at the end of the 14-day observation period, surviving animals were individually weighed.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No
- Clinical signs:
- other: No symptoms
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- LD0 = 5000 mg/kg in rats.
- Executive summary:
Method
Acute oral toxicity in rats (5 M and 5 F) dosed at 5000 mg/kg by gavage. A 14 -days observation period followed administration.
Results
During the observation period, no deaths occurred, no symptoms were recorded, body weight gain was unaffected.
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