4-propylcyclohexanone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-03-04 to 1990-05-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-propylcyclohexanone

EC Number:

406-810-4

EC Name:

4-propylcyclohexanone

Cas Number:

40649-36-3

Molecular formula:

C9H16O

IUPAC Name:

4-propylcyclohexan-1-one

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Chbb: THOM

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Thomae, Biberach
- Age at study initiation: about 5 to 9 weeks
- Weight at study initiation (mean): 185 (169-207) g
- Fasting period before study: The rats did no receive any food from 17 hours before up to 4 hours after treatment.
- Housing: They were housed under conventional conditions in a 60 m² room with daylight and artificial fluorescent ligth (6 a.m. - 6 p.m.). The treated rats were kept separately in Makrolon cages type III (floor area: 37.5 x 21 cm = 787.5 cm², height: 15 cm) on mobile racks. During the acclimatization phase and on the day of treatment, the animals were kept on metal grids (placed above the softwood granulate) and then on conventional softwood granulate as bedding. The cages and the metal grids had been machine-cleaned before the beginning of the study. The bedding was changed three times a week.
- Diet: ad libitum, Altromin Strandard Diet Total Pathogen Free TPF N1324
- Water: ad libitum, tap water
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 - 29 °C
- Humidity (%): 33 - 46%
- Photoperiod: light phase from 6 a.m. to 6 p.m.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 3.31 mL/kg

Doses:

1500, 2000, 2500 and 3000 mg/kg

No. of animals per sex per dose:

1500, 2500 and 3000 mg/kg: 5 females;
2000 mg/kg: 5 males and 10 females;
A further 10 animals (5 males and 5 females) from another study (T 13319) served as controls for body weight development.

Control animals:

yes

Remarks:

control rats were treated with 10 mL/kg of 0.25% aqueous Methocel K 4M Premium solution)

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Behavior and general condition of all rats were monitored for 4 - 6 hours after administration and then checked daily. All rats were weighted before treatment, as well as on days 2, 4, 6, 8, 11, 13 and 15 of the study.
- Necropsy of survivors performed: yes
All the rats which died and which were sacrificed at the end of the study by CO2-asphyxia were subjected to gross pathological investigation.

Statistics:

The body weight data were processed by means of the program TOX 511 A, developed by the Department of Technical and Scientific Data Processing of E. Merck, Darmstadt.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Only one female rat dosed with 2000 mg/kg died 6 hours after treatment. All the other rats survived the observation period.

Body weight:

Inhibition of body weight development and decreased body weight were observed on day 2 mainly.

Gross pathology:

In the female rat that died and all the rats that were sacrificed at the end of the observation period no organ alterations were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the result of this study, it is concluded that the test material has no acute toxic potential. The LD50 for males and females, after an observation period of 15 days was >2000 mg/kg.

Executive summary:

A study according OECD TG 401 was performed to determine the acute toxicity of the test item after oral administration of 1500, 2000, 2500 and 3000 mg/kg bw to rats. The animals were observed for 15 days. Behavior and general condition of all rats were monitored for 4-6 hours after administration and then checked daily. All rats were weighed before treatment, as well as on days 2, 4, 6, 8, 11, 13 and 15 of the study. Necropsy was performed. Intoxication symptoms started directly after treatment and lasted up to day 2. The symptoms were: Dyspnea, locomotor disturbance, lateral and abdominal position, piloerection, salivation, pale faeces, retention of faeces, increased lacrimation, and wet anal region. Only one female rat dosed with 2000 mg/kg died 6 hours after treatment. All the other rats survived the observation period. Inhibition of body weight development and decreased body weight were observed on day 2 mainly. In the female rat that died and all the rats that were sacrificed at the end of the observation period no organ alterations were seen. The median lethal dose (LD50 ) for males and females, after an observation period of 15 days, was > 2000 mg/kg bw.