Registration Dossier
Registration Dossier
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EC number: 215-403-9 | CAS number: 1325-65-1 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 40290.
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:
- 1 976
- Report date:
- 1976
Materials and methods
- Principles of method if other than guideline:
- 5/rat/sex; limit test; 14-days observation period
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Direct Red 111
- IUPAC Name:
- Direct Red 111
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 15 g in 50 ml
MAXIMUM DOSE VOLUME APPLIED: 16.7 ml / kg
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: day 0, day 7, day 14
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None.
- Body weight:
- Weight in g
male day 0 day 7 day 14
1 160 210 255
2 135 180 235
3 155 200 240
4 165 210 260
5 155 200 240
female
6 160 180 205
7 160 170 185
8 155 170 185
9 155 165 190
10 150 165 180
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- LD50 > 5000 mg/kg
- Executive summary:
Method
5 rat/sex were dosed by oral route at 5000 mg/kg as single dose. Observations were carried out for 14 days after dosing.
Results
No mortality was recorded. LD50 > 5000 mg/kg.
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