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Description of key information

LD50(oral) > 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:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
from October 25 to November 30, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13
Qualifier:
equivalent or similar to
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 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:
other: CLP criteria not met
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

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

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

In the case of oral exposure route, the acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are:

- category 1: ATE ≤ 5 mg/kg bw

- category 2: 5 < ATE ≤ 50 mg/kg bw

- category 3: 50 < ATE ≤ 300 mg/kg bw

- category 4: 300 < ATE ≤ 2000 mg/kg bw

The acute oral LD50 in rats was established to be greater than 10000 mg/kg bw, therefore, the substance is not classified for oral acute toxicity according to the CLP Regulation (EC n. 1272/2008).