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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
Cited as Directive 84/449/EEC, B.1
Deviations:
yes
Remarks:
; purity not reported
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
; purity not reported
GLP compliance:
no
Remarks:
test was performed prior to GLP-requirement
Test type:
standard acute method
Limit test:
no

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
- Source: Winkelmann, Borchen
- Age at study initiation: females 64-72 d; males 51-59 d
- Weight at study initiation: females 141-158 g; males 127-187 g
- Fasting period before study: 16 h; overnight
- Housing: individually Macrolon cage type II
- Diet: ssniff, ad libitum
- Water: ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS: according to guideline

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
peanut oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 112; 164; 241; 353 and 518 g/ L
- Amount of vehicle (if gavage): 2.15 mL/ kg
Doses:
male: 353, 518, 760, 1116 mg/ kg bw
female: 240, 518, 1116 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 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
Probit analysis

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
760 mg/kg bw
Based on:
test mat.
95% CL:
345 - 1 671
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
927 mg/kg bw
Based on:
test mat.
95% CL:
587 - 1 464
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
753 mg/kg bw
Based on:
test mat.
95% CL:
578 - 1 070
Mortality:
Male
353 mg/ kg : 0/5
518 mg/ kg : 1/5 day 3 p.a.
760 mg/ kg : 2/5 day 2 and 3 p.a.
1116 mg/ kg : 4/5 day 2 and 3 p.a.

Female
240 mg/ kg : 0/5
518 mg/ kg : 2/5 day 2 and 3 p.a.
1116 mg/ kg : 4/5 day 2 and 3 p.a.
Clinical signs:
ataxia, decrease of muscle tone, loss of reflexes, strenuous respiration, lacrimation, decrease of salivation, piloerection
Gross pathology:
highest dose group: red coloured fluid in the stomach (all animals), brightening of liver (1 animal)
Other findings:
Signs of toxicity occurred as early as 5 min p.a. and were evident until 4 days p.a. in the surviving animals. Deaths occurred on day 2 or 3 p.a.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The test substance caused death under the conditions tested. The LD50 is considered to be 753 mg/kg bw males/females as well as for females alone. Predominant clinical signs observed were ataxia, decrease of muscle tone, loss of reflexes, strenuous respiration, lacrimation, decrease of salivation, piloerection which were present 5 min p.a. and remaind by day 4 p.a.