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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From July 14, 1981 to September 7, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 100 - 180 g
- Fasting period before study: 18 hours after and 4 hours before administration of test item
- Diet: UAR D-04, ad libitum
- Water: deionised water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 1 °C
- Humidity (%): 65 ± 5 %
- Photoperiod (hrs dark / hrs light): 12 hour cycle dark/light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: suspension 1% with CMC and 2% with water
- Amount of vehicle (if gavage): 40 ml/kg
Doses:
4000, 8000, 16000 mg/kg
No. of animals per sex per dose:
5 per sex per doses
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 16 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 4 800 mg/kg bw
Based on:
act. ingr.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 4 000 mg/kg bw
Based on:
act. ingr.
Mortality:
For concentrations above 4000 mg/kg
Clinical signs:
No signs of toxicity
Gross pathology:
At highest dose one of the surviving rats presents the kidneys of pale colour

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation (EC n. 1272/2008)
Conclusions:
The substance shows a LD50 =16000 mg/kg b.w.
Executive summary:

The substance has been tested for acute toxicity by oral route according to a method similar to the one described by OECD Guideline 401; 30 Wistar rats are tested with the substance at concentration of 4000, 8000 and 16000 mg/kg by gavage, 10 animals per dose.

During the study the following rates of mortality were observed:

At the dose of 4000 mg/kg no mortality was observed and at the dose of 8000 mg/kg bw one rat were found dead. At the highest dose tested 5 rats died.

Results

LD50 = 16000 mg/kg bw