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Toxicological information

Acute Toxicity: oral

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Administrative data

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 December 12, 1978 to January 10, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The test was conducted on a similar substance. Further details were reported in the attachment at section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
Study conducted before 1981
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7 to 8 weeks old
- Fasting period before study: overnight before treatment
- Housing: housed in groups of 5 in Macrolon cages
- Diet: NAFAG, Gossau SG ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
VEHICLE
- Amount of vehicle : 10, 20 ml/kg
The test item was suspended. Before treatment the suspension was homogeneously suspended with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
Doses:
Doses (mg/kg bw) : 1000, 2000, 3000, 5000
Volume (ml/kg bw): 10, 20
No. of animals per sex per dose:
5 per sex per dose
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
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 2 122 mg/kg bw
Based on:
test mat.
Remarks on result:
other: effect level in a range of 1656-2619 mg/kg bw
Mortality:
(1000 mg/kg bw) no deaths; (2000 mg/kg bw) 4 death; (3000 mg/kg bw) 9 death; (5000 mg/kg bw) all animals were found dead
Clinical signs:
Sedation, Dyspnoea, Exophtalmos, Ruffled fur, Body Position (Curved) in all the concentration tested.
Diarrhoea was observed at doses of 1000, 2000 and 3000 mg/kg bw.
Convultions were observed at the dose of 5000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 (male/female) = 2122 mg/kg bw
Executive summary:

Method

The test substance was tested for Acute Oral Toxicity on rats according to a method similar to the OECD Guideline 401. Five animals per sex per dose were administered by gavage with the test item at four different concentrations ( 1000, 2000, 3000 and 5000 mg/kg bw).

Observations

During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages. Animals fasted overnight were treated by oral intubation. Physical condition and rate of deaths were monitored throughout the whole observation period.

During the test Sedation, Dyspnoea, Exophtalmos, Ruffled fur, Body Position (Curved) in all the concentration tested. Diarrhoea was observed at doses of 1000, 2000 and 3000 mg/kg bw. Convultions were observed at the dose of 5000 mg/kg bw.

At 1000 mg/kg bw no deaths occurred and at the maximum dose (5000 mg/kg bw) all the animals were found dead, at the other concentrations the following number of animals were found dead: 4 animals at 2000 mg/kg bw and 9 animals at 3000 mg/kg bw.

Conclusion

LD50 (male/female) = 2122 mg/kg bw