4-cyclohexyl-4-methylpentan-2-one

Endpoint summary

Description of key information

The substance is not acute oral toxic. The LD50 value is greater than 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06.08.1991 - 22.08.1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

February 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

Crl. : (WI) BR - Wistar, white

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: males: 172 - 190 g; females: 150 - 164 g
- Fasting period before study: from 16 h before until 3 - 4 h after administration of the test article.
- Housing: collective housing up to a maximum of 5 animals per cage (Macrolon type III)
- Diet: ad libitum Ssniff-R Alleindiät
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30- 70
- Photoperiod (hrs dark / hrs light): light from 7.00 a.m. - 7.00 p.m.
- Lighting: artificial lighting (120 lux)

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DOSAGE PREPARATION: administered volume was 2.2 mL/kg bw
RANGE FINDING STUDY: A preliminary range finding test with a dose of 2000 mg/kg bw was conducted using two female rats.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males + 5 females

Control animals:

no

Details on study design:

- Preparation of animals: food deprivation for 16 h
- Duration of observation period following administration: 14 days
- Clinical observation: yes: Irwin Screening procedure; animals were examined at post-treatment intervals: 10 min, 1 h, 2 h, 6 h, 24 h, and thereafter once daily up to day 14.
- Frequency of weighing: days 0, 7 and 14
- Necropsy of survivors performed: yes, animals were sacrificed by CO2 asphyxiation after 14 days
- Other: gross pathological examination

Preliminary study:

No deaths occurred in the range finding study with 2 females.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the main study.

Clinical signs:

other: No abnormal clinical signs were observed.

Gross pathology:

Gross pathological examinations at 14 days p. a. (terminal necropsy) revealed no test article-dependent findings.

Interpretation of results:

other: CLP criteria not met

Conclusions:

The acute oral LD50 is determined to be >2000 mg/kg bw for male and female rats.

Executive summary:

The aim of the study was to determine the acute median lethal dose of the test item. The study was conducted according to the OECD TG 401 and GLP.

The acute oral toxicity was investigated in 5 male and 5 female Wistar rats. Based on a range finding study the animals were given a single oral dose of 2000 mg/kg bw. Clinical observation were performed at regular intervals during the 14-day observation period, including body weight and gross pathology examinations.

No mortalities occurred and no abnormal clinical signs were observed. The weight gain was normal in all animals. Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings. 


According to the requirements of the limit test, the LD50 value after 24 h and 14 days for 
male and female was > 2000 mg/kg bw.

This value is higher than the limit specified as harmful by the CLP regulation, therefore the test item should not be classified for acute oral toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

For acute oral toxicity there is one study available determining the lethal dose of the test item after oral administration. The study was conducted according to the OECD 401 and GLP.

10 rats were given a single oral dose of 2000 mg/kg bw and clinical observations were performed at regular intervals during the 14-day observation period. Body weight and gross pathology examinations were performed.

No animals died during the study. No abnormal clinical signs were observed. The weight gain was normal in all animals and the gross pathological examinations revealed no test article dependent findings. 


The oral LD50 is greater than 2000 mg/kg
 bw.

Justification for classification or non-classification

In Table 3.1.1 of Annex I of the CLP Regulation No 1272/2008 the criteria are depicted for the classification of a substance for acute oral toxicity. The substance has an LD50 > 2000 mg/kg bw. Therefore, the substance should not be classified according to the CLP Regulation not for the oral route.