2-butyryl-3-hydroxy-5-thiocyclohexan-3-yl-cyclohex-2-en-1-one

Acute Toxicity: oral

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

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

425-150-8

EC Name:

-

Cas Number:

94723-86-1

Molecular formula:

C15 H22 O3 S

IUPAC Name:

2-butanoyl-3-hydroxy-5-(thian-3-yl)cyclohex-2-en-1-one

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 or test system 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:

other: 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

Gross pathology:

deceased animals: agonal congestion
sacrificed animals: no abnormalities detected