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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
Reference
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:
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.

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