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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:
1979 - 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
according to BASF-internal standard, see details in the section "Any other information on materials and methods incl. tables".
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hagemann, Germany
- Age at study initiation: Not specified
- Weight at study initiation: 280-180 g (males), 220-180 g (females)
- Fasting period before study: 15 h – 20 h before administration
- Housing: Not specified
- Diet: Standardized animal laboratory diet (Herilan mouse/rat/hamster maintenance diet supplied by H. Eggersmann KG, Germany)
- Water: Not specified
- Acclimation period: Not specified
- Date of first administration: May 11, 1979
- Date of last administration: June 20, 1979

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Form of administration: solution
- Concentration in vehicle (%, w/v): 6.81, 10.0, 14.7, 21.5 (to obtain 681, 1000, 1470, 2150 mg/kg)
- Amount of vehicle: 10 mL/kg per dosage
- Justification for choice of vehicle: solubility

MAXIMUM DOSE VOLUME APPLIED:
- Admin. vol. (mL/kg): 10
Doses:
681, 1000, 1470, 2150 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
Probit Analysis (Finney DJ, Cambridge University Press, 3rd ed., 1971)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
984 mg/kg bw
Based on:
test mat.
95% CL:
>= 805 - <= 1 197
Remarks on result:
other: Doses used for calculation: 691, 1000, 1470 mg/kg bw
Mortality:
Male animals: 681 and 1000 mg/kg: 1/5 after 14 days, 1470 and 2150 mg/kg: 5/5 after 14 days
Female animals: 681 mg/kg: 1/5 after 14 days; 1000 mg/kg: 2/5 after 14 days; 1470 and 2150 mg/kg: 5/5 after 14 days
Clinical signs:
Highest dose level: dyspnea, gasping, apathy, anomalous position, staggering, spastic gait, piloerection, cyanosis, ecsiccosis, poor general state
Body weight:
Mean body weights of male animals: beginning of study 24 g (50 and 200 mg/kg), after 13 days 31.6 g (50 mg/kg)
Mean body weights of female animals. beginning of study 22 g (50 and 200 mg/kg), after 13 days 25.4 g (50 mg/kg)
Gross pathology:
Animals that died: Heart: acute dilatation right-sided ; acute congestion; stomach: atonic, liquid blood-coloured contents, in the region of the glandular stomach severe diffuse reddening (corrosive gastritis); intestine: atonic, diarrheal contents, enteritis.
Sacrificed animals: No pathologic findings noted.

Any other information on results incl. tables

In an acute oral toxicity study according to an internal BASF method (BASF, 1980), Sprague Dawley rats were given a single oral dose of the test substance diluted in water at 681, 1000, 1470 or 2150 mg/kg bw. Animals were then observed for mortality and for clinical symptoms of toxicity for 14 days. All animals were subjected to necropsy. As clinical signs dyspnea, gasping, apathy, anomalous position, staggering, spastic gait, piloerection, cyanosis, ecsiccosis, and poor general state were noticed at the highest dose level. The oral LD50 was estimated as 984 mg/kg bw. This acute oral study is classified as acceptable. It satisfies the guideline requirement for an acute oral study according to OECD 401 in principle.

Applicant's summary and conclusion