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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:
August 1970
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:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
Preparation and administration of doses
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Four batches of the test substance were examined.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Test animals:
Weight between 125 and 155 g

Housing and feeding conditions:
The temperature of the experimental animal room was 22°C. The relative humidity was 45-55%. Lighting was artificial, the sequence was 12 hours light, 12 hours dark. Food and water was provided at discretion.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The test substance was administered in a 20% slightly viscose and water solved form. The animals fasted prior dosing (only food) for 16 hours.
Doses:
The doses were chosen by a previous range finding.
Batch 1 and 3: 2520, 3175, 4000, 5040 mg/kg bw
Batch 2 and 4: 3175, 4000, 5040, 6350 mg/kg bw
No. of animals per sex per dose:
For each step the substance is tested on five males and five females.
Details on study design:
The 24 h and 14 d (follow-up time) LD50 values were determined.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
24 h
Effect level:
>= 3 580 - <= 4 990 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Batch 1
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
14 d
Effect level:
>= 3 060 - <= 3 640 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Batch 1
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
24 h
Effect level:
>= 3 820 - <= 6 650 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Batch 2
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
14 d
Effect level:
>= 3 800 - <= 5 760 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Batch 2
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
24 h
Effect level:
>= 3 400 - <= 4 990 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Batch 3
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
14 d
Effect level:
>= 2 500 - <= 3 430 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Batch 3
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
24 h
Effect level:
>= 5 050 - <= 5 990 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Batch 4
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
14 d
Effect level:
>= 4 670 - <= 5 440 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Batch 4
Clinical signs:
In the higher dosages of the test substance light to strong apathy, moribund behaviour in lateral position and a reduced respiration rate were observed. In the highest dosages, the animals died partly already after 10 minutes.
Body weight:
During the follow-up time of 14 days and under the test conditions, no substance- or dosage-related weight gains of the animals were observed.
Gross pathology:
Next to the preparation-related intestinal discoloration, no study-related changes in cranial, chest and abdominal cavity were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
All LD50 values are above the classification value of 2000 mg/kg bw. Therefore, the GHS criteria is not met.
Executive summary:

Four batches of test substance were studied in an acute oral toxicity test on rats. Under the above-mentioned conditions, following "dosis letalis media" were determined:

Batch 1 LD50/24 h: 4230 mg/kg bw and LD50/14 d: 3340 mg/kg bw

Batch 2 LD50/24 h: 5040 mg/kg bw and LD50/14 d: 4680 mg/kg bw

Batch 3 LD50/24 h: 4120 mg/kg bw and LD50/14 d: 2930 mg/kg bw

Batch 4 LD50/24 h: 5500 mg/kg bw and LD50/14 d: 5040 mg/kg bw