Cyclohexane, oxidized, non-acidic by-products, distn. residues

Acute Toxicity: oral

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: Guideline study with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Remarks:

(BASF AG, Department of Experimental Toxicology and Ecology)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexane, oxidized, non-acidic by-products, distn. residues

EC Number:

271-816-4

EC Name:

Cyclohexane, oxidized, non-acidic by-products, distn. residues

Cas Number:

68609-04-1

IUPAC Name:

(1s,4s)-cyclohexane-1,4-diol (cyclohexyloxy)cyclohexane 2-butylcyclohexan-1-one 8-oxatricyclo[7.4.0.0^{2,7}]trideca-1(9),2(7)-diene cyclohexane cyclohexane-1,3-diol cyclohexanol phenol hydrate

Details on test material:

- Name of test material (as cited in study report): Anone-Oil Split K1
- Physical state: viscous, black
- Analytical purity: 9.4 peak area %; main component (GC)
- Lot/batch No.: 96075-3
- Stability under test conditions: stability of the test substance in olive oil DAB10 for a time period of 4 hours was confirmed by analysis
- 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
- Age at study initiation: young adult
- Weight at study initiation: 150-300 g (± 20% of the mean weight)
- Fasting period before study: 16 h before administration
- Housing: single
- Diet (e.g. ad libitum): Kliba Labordiet 343, Kaiseraugst
- Water (e.g. ad libitum): tap water
- Acclimation period: 1 week


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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle (g/100 ml): 40
- Amount of vehicle (if gavage): 5 ml/kg bw
- Justification for choice of vehicle: not homogeneously distributed in aqua bidest

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance and the composition, no pronounced acute oral toxicity was expected . Therefore a dose of 2000 mg/kg bw has been chosen.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 16 days for males and 14 days for females.
- Frequency of observations and weighing: Individual body weights shortly before application, weekly thereafter and at the end of the study. Recording of the signs and symptoms several times on the day of administration, at least once each workday for the individual animals. A check for any dead or moribund animal was made twice each workday and once on weekends and holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortalities were observed

Clinical signs:

no clinical signs were onserved in males. In females, impaired general state, dyspnoea, staggering and piloerection were observed. These symptoms were considered to be unspecific toxicity symptoms, and were reversible within one day.

Body weight:

normal body weight gain was observed in male and female animals.

Gross pathology:

no abnormalities were detected