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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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
only one sex tested, limitations in study reporting
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

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

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Test animals:
- Strain: Hoe WISKf(SPF71)
- Source: Hoechst AG Kastengrund - SPF breed
- Weight at study initiation: 90-112 g (female); (mean = 100 g; n = 60)
- Age at study initiation: no data
- Fasting period before study: 16 hours before and 2 hours after application
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum
- Water: Tap water ad libitum
- Acclimatization period: no data

Environmental conditions:
- Housing: in groups, in plastic cages, softwood pellets

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Concentration in vehicle: 25 % (w/v)
Doses:
6300, 8000, 9000, 10000, 12500 and 15000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations after application / weighing once weekly
- Necropsy of survivors performed: yes
Statistics:
Probit analysis (method by Linder and Weber); Confidence limits according to Cavalli-Sforza

Results and discussion

Preliminary study:
Preliminary experiments did not show differences related to gender. Therefore only females used for main study.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
10 490 mg/kg bw
Based on:
test mat.
95% CL:
> 9 833 - <= 11 191
Remarks on result:
other: corresponding to 2623 mg a.i./kg bw
Remarks:
with a concentration correction of 25%
Mortality:
Mortality rate:
- 6300 mg/kg bw: 0 / 10
- 8000 mg/kg bw: 0 / 10
- 9000 mg/kg bw: 0 / 10
- 10000 mg/kg bw: 5 / 10
- 12500 mg/kg bw: 9 / 10
- 15000 mg/kg bw: 10 / 10
Clinical signs:
Mortally poisened animals died within 1-2 days after application. Following symptoms were observed: disturbance of equilibrium, spasm. The test substance was vomitted.
Body weight:
Normal body weight gain was observed in all surviving animals.
Gross pathology:
Dissection of rats killed at the end of the observation period revealed no macroscopic findings. Necropsy of the deceased animals revealed following macroscopic findings: stomach and oesophagus were filled with white foam.

Applicant's summary and conclusion

Conclusions:
Under the study conditions, the female rat LD50 of the test substance was determined to be 10490 mg/kg bw, corresponding to 2623 mg a.i./kg bw (oral: gavage).
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance according to OECD guideline 401 (standart acute method). The test substance was administered by gavage to ten female Wistar rats at concentrations of 0, 6300, 8000, 9000, 10000, 12500 and 15000 mg/kg bw (25%, in water). The duration of the observation period following administration was 14 days. Clinical observations were recorded after application and weighing once weekly. Macroscopic examination was performed on all animals. Mortality occurred in the groups 10000, 12500 and 15000 mg/kg bw (5, 9 and 10/10, respectively). Mortally poisened animals died within 1-2 days after application. Disturbance of equilibrium and spasm were observed. The test substance was vomitted. Normal body weight gain was recorded in all surviving animals. Dissection of rats killed at the end of the observation period revealed no macroscopic findings. Necropsy of the deceased animals revealed the following macroscopic findings: stomach and oesophagus were filled with white foam. Under the study conditions, the female rat LD50 of the test substance was determined to be 10490 mg/kg bw, corresponding to 2623 mg a.i./kg bw (1974).