Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 625-Triketone
- Substance No.: 93/239
- Physical state: Powder, slight yellow
- Analytical purity: 99.2 %
- Purity test date: 25.-27.04.1994
- Lot/batch No.: 25918/77
- Date of manufacturing: 01-Sep-1993
- Stability under test conditions: verified by reanalysis
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Strain/Quality: WISTAR / CHBB: THOM (SPF)
- Age at study initiation: young adult animals
- Weight at study initiation: animals of comparable weight; (150 g – 300 g)(± 20 % of the mean weight)
- Fasting period before study: 16 hours
- Housing: single housing
- Diet: KLIBA-Labordiaet 343, Klingenthalmuehle AG Kaiseraugst, Switzerland, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Analysis of drinking water
The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the technical services of the BASF AG as well as for the presence of germs by a contract laboratory.

Analysis of feed:
The feed used in the study was assayed for chemical and microbial contaminates.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 g/100 ml and 20 g/100 ml, respectively
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: the test substance is hardly soluble in water or water-based solvents


Doses:
200, 2000 mg/kg bw
No. of animals per sex per dose:
2000 mg/kg bw dose group: 3 males
200 mg/kg bw dose group: 3 females and 3 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: at least once daily, several times on the day of application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - < 2 000 mg/kg bw
Mortality:
2000 mg/kg bw dose group: all animals died
200 mg/kg bw dose group: no death recorded
Clinical signs:
2000 mg/kg bw dose group: impaired or poor general state, dyspnoea, apathy, lateral position, staggering, ataxia, paresis, tremor, twitching, spastic gait, clonic convulsions, tonic-clonic convulsions, spasm of jaws, smeared fur, diarrhea, salivation and red adhesive snout and margins of the eyelids
200 mg/kg bw dose group: no symptoms recorded.
Body weight:
200 mg/kg bw: The expected body weight gain has been observed in the course of the study.
2000 mg/kg bw: Due to the exitus of all animals, body weights could not be determined
Gross pathology:
deceased animals: agonal congestion
sacrificed animals: no abnormalities detected

Applicant's summary and conclusion