4-pentylcyclohexanone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 14 until April 24, 1990

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:

adopted February 24, 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-pentylcyclohexanone

EC Number:

406-670-4

EC Name:

4-pentylcyclohexanone

Cas Number:

61203-83-6

Molecular formula:

C11H20O

IUPAC Name:

4-pentylcyclohexan-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 186 (172 - 205) g
- Fasting period before study: The rats did not receive any food from 17 hours before up to 4 hours after treatment.
- Housing: separately in Makrolon cages type III
- Diet: ad libitum, Altromin Strandard Diet Total Pathogen Free TFF N1324
- Water: ad libitum, tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25-27
- Humidity (%): 36-46
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.79 mL/kg

Doses:

1500, 2000, 2500 mg/kg bw

No. of animals per sex per dose:

5
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:

The control rats were treated with 10 mL/kg of a common carrier medium (0.25 % aqueous Methoce1 K 4M Premium solution).

Details on study design:

- Duration of observation period following administration: 14 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 weighed 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.

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:

Two female rats, dosed with 2000 mg/kg, died 6 hours or 2 days after treatment, respectively. Only one rat dosed with 2500 mg/kg died on day 2. All the other rats survived the observation period.

Clinical signs:

Intoxication symptoms started directly after treatment and lasted up to day 3. The symptoms were: Dyspnea, locomotor disturbance, abdominal position, piloerection, pale faeces, retention of faeces, increased lacrimation, and wet anal region.

Body weight:

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

Gross pathology:

One rat that died showed inspissation of faeces in the cecum. The second rat showed focal hemorrhage in the left adrenal. The third one was without special findings.
In all rats which 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 and that the LD50 value is higher than 2000 mg/kg bw after oral treatment in rats.

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 and 2500 mg/kg bw to rats (5 animals/sex/dose). The animals were observed for 14 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 3. The symptoms were: Dyspnea, locomotor disturbance, abdominal position, piloerection, pale faeces, and retention of faeces, increased lacrimation, and wet anal region. Two female rats, dosed with 2000 mg/kg bw, died 6 hours or 2 days after treatment, respectively. Only one rat dosed with 2500 mg/kg bw died on day 2. All the other rats survived the observation period. Inhibition of body weight development and decreased body weight were observed on day 2 mainly. One rat that died showed inspissation of faeces in the cecum. The second rat showed focal hemorrhage in the left adrenal. The third one was without special findings. In all rats which 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.