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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:
1978-02-13 to 1979-11-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
BASF test
GLP compliance:
no
Test type:
other: BASF method
Limit test:
no

Test material

Reference
Name:
Unnamed
Test material form:
solid
Specific details on test material used for the study:
0.5-50% solution in 0.5% aqueous carboxymethylcellulose preparation

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% aqueous carboxymethylcellulose preparation
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.5 to 50%
Doses:
top dose: 5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
Probit analysis

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 3 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: corresponding to 1225 mg/kg bw act. ingr.
Mortality:
protracted death, no further data on mortality provided
Clinical signs:
During first week bad general condition observed. Further adverse clinical signs of toxicity were: apathy, hyperesthesia, aggressive, ataxia, tremor, muscle twitches, clonic convulsion, diarrhoea and salivation, spastic movement
Body weight:
Body weight loss during the first week of experiment
Gross pathology:
Animals, which died during observation period: Heart: dilatation (right), acute hyperemia; intestine: atonic, diarrheic content; stomach: dilated, substance-filled
Sacrificed animals: no adverse effects

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In an acute oral toxicity study, the LD50 of the test item was determined to be 3500 mg/kg bw in rats.By extrapolating the concentration of 50% of the test item to 100% (undiluted), and furthermore to 100% dye content, the calculated LD50 can be considered to be 1225 mg/kg bw. Thus, the substance is considered to be classified as Acute Toxic Cat. 4.
Executive summary:

In an acute oral toxicity study, rats were given a single oral dose of 0.5 -50% suspension of the test item diluted in 0.5% aqueous carboxymethylcellulose. An unknown number of animals died during the study. At the first week a bad in the general condition was observed. Moreover, adverse clinical signs of toxicity were observed, such as apathy, hyperesthesia, aggressive, ataxia, tremor, muscle twitches, clonic convulsion, diarrhoea, salivation, and spastic movements. A body weight loss during the first week of experiment was reported. Based on the results from this study, the LD50 of the test item was determined to 3500 mg/kg in rats. By extrapolating the concentration of 50% of the test item to 100% (undiluted), and furthermore to 100% dye content, the calculated LD50 can be considered to be 1225 mg/kg bw. Thus, the substance is considered to be classified as Acute Toxic Cat. 4.