(R)-6-(isopropyl)-3-methylcyclohex-2-en-1-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 June - 14 July 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

in compliance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

17 Dec 2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(R)-6-(isopropyl)-3-methylcyclohex-2-en-1-one

EC Number:

224-957-0

EC Name:

(R)-6-(isopropyl)-3-methylcyclohex-2-en-1-one

Cas Number:

4573-50-6

Molecular formula:

C10H16O

IUPAC Name:

(R)-6-(isopropyl)-3-methylcyclohex-2-en-1-one

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

(Crl:CD(SD)), SPF

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ORIENTBIO INC., Republic of Korea
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 183.9 - 232.3 g
- Fasting period before study: animals were fasted overnight prior to administration
- Housing: individual in wire mesh cages. Cages were washed every two weeks in a cage washer and sterilized by an autoclave.
- Diet: pellet diet Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C (Envigo RMS. Ltd., U.S.A., lot No. 2918C-020816MA), ad libitum
- Water: tap water, ad libitum (analysis was performed)
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.6 - 24.1
- Humidity (%): 43.8 - 70.0
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/ 12

IN-LIFE DATES: From: 14 June TO: 28 June 2016

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 60 and 400 mg/mL
- Amount of vehicle (if gavage): 5.0 mL per kg bw
- Lot/batch no. (if required): MKBV2080V

MAXIMUM DOSE VOLUME APPLIED: 5.0 mL per kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The starting dose level for this study was selected at 300 mg/kg bw because there was no available toxicity information on the test substance.

Doses:

300 mg/kg bw and 2000 mg/kg bw

No. of animals per sex per dose:

6 females per dose

Control animals:

no

Remarks:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On Day 0, all animals were observed once within 30 minutes and once each at 1, 2, 4 and 6 hours after dosing. From the next day of dosing (from Day 1 to Day 14), the animals were observed once daily. All animals were weighed on Days 0 (before dosing), 1, 3, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights, complete gross postmortem examinations

Statistics:

Mean values and standard deviations were calculated for body weights.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 is a cut-off value obtained from flow-chart of OECD 423 (Annex 2c)

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Group 1: 300 mg/kg bw: No clinical abnormalities were observed in any animal. Group 2: 300 mg/kg bw: No clinical abnormalities were observed in any animal. Group 3: 2000 mg/kg bw step 1: On Day 0, salivation was observed in all 3 animals after 30 minutes

Gross pathology:

No abnormal morphological findings were observed in any animal at 300 and 2000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

CLP: not classified

Executive summary:

The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 423 and in compliance with GLP (2016). Based on lacking toxicity information on the test substance, the starting dose was selected to be 300 mg/kg bw via gavage, tested in 3 female rats. As no mortality or clinical signs occurred the test was performed again at a dose of 2000 mg/kg bw. No mortality occurred at this dose too.

Thus, a LD50 value > 5000 mg/kg bw was found in this study.