Registration Dossier
Registration Dossier
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EC number: 276-701-2 | CAS number: 72496-88-9
Endpoint summary
Administrative data
Description of key information
Acute Oral LD50 > 10000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from October 25 to November 30, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to internationally accepted testing procedures.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- Pre GLP.
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- other: RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Tif
- Age at study initiation: 7 to 8 weeks old
- Weight at study initiation: males 206.5 g, females 182 g
- Fasting period before study: Animals fasted overnight
- Housing: 5 in Macrolon cages (type 3)
- Diet: ad libitum rat food NAFAG, Gossau SG
- Water: ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C
- Humidity (%): 55 ± 10 %
- Photoperiod: 10 hours of light during the day - Route of administration:
- oral: gavage
- Vehicle:
- other: carboxymethyl-cellulose 2 % (w/v) in dest. water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:20 ml/kg bw - Doses:
- 5000, 7000, 8000, 10000 mg/kg
- No. of animals per sex per dose:
- 5 x sex x doses
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days
- Necropsy of survivors performed: yes - Statistics:
- LD50 including 95 % confidence limits are calculated by the logit model.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- ca. 10 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed
- Clinical signs:
- other: Dhiarroea, Ruffled fur, Dyspnoea.
- Gross pathology:
- No substance related gross organ changes were seen
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 of test substance in rats of both sexes observed over a period of 14 days is greater than 10000 mg/kg bw.
- Executive summary:
The acute oral LD50 of test substance in rats of both sexes observed over a period of 14 days is greater than 10000 mg/kg bw. The test material has therefore practically no acute toxicity to the rat by this route of administration.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
- Quality of whole database:
- All tests for acute toxicity are conducted with international accepted procedures, but not with GLP criteria.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acid Yellow 151 presents only slight
signs of toxicity after oral administration of large quantities (eg 10000
mg /kg bw).
The
test material has therefore practically no acute toxicity to the rat by
this route of administration.
Justification for selection of acute toxicity – oral endpoint
The study made in 1979 was more detailed than the study made in 1976. Physical condition and rate of deaths were monitored throughout the whole observation period.
In the study made in 1976 the schedule was not described and there is no tables
Justification for classification or non-classification
Acute toxicity means those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours. Based on the CLP definition, Acid Yellow 151 cannot be allocated to one of four toxicity categories; based on acute toxicity by the oral route according to the numeric criteria shown in Table 3.1.1 of the CLP Regulation; therefore it can be assumed that :
No classification for acute toxicity oral is warranted under the Regulation EC n. 1272/2008
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