Reaction mass of 1-(3,3-dimethylcyclohexyl)ethanone and 2,6,6-trimethylcycloheptanone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6 August 1991 - 22 August 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

4-cyclohexyl-4-methylpentan-2-one

EC Number:

225-562-6

EC Name:

4-cyclohexyl-4-methylpentan-2-one

Cas Number:

4927-39-3

Molecular formula:

C12H22O

IUPAC Name:

4-cyclohexyl-4-methylpentan-2-one

Test animals

Species:

rat

Strain:

other: Crl.: (WI) Br - Wistar, white

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma Charles River Wiga, Sandhofer Weg 7, 8741 Sulzfeld
- Weight at study initiation: male: 172 - 190 g, female: 150 - 164 g
- Fasting period before study: The animals were fasted 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 (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- 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: 2.2 mL/kg bw


CLASS METHOD: A preliminary range finding test with a dose of 2000 mg/kg body weight was conducted using two female rats.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Body weights were recorded immediately before treatment (day 0) and an days 7 and 14 p.a. (termination).
- Necropsy of survivors performed: The animals were sacrificed by CO2 asphyxiation after 14 days and gross pathological examinations were subsequently performed.
- Other examinations performed: clinical signs

Results and discussion

Preliminary study:

There were no deaths in the preliminary study.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died during the course of the main study.

Clinical signs:

No abnormal clinical signs were observed.

Body weight:

Weight gains were normal in all animals.

Gross pathology:

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

Applicant's summary and conclusion

Interpretation of results:

other: Not acute harmful.

Remarks:

According to Regulation (EC) No. 1272/2008 and its amendments

Conclusions:

The acute oral toxicity test with the substance showed an LD50 of >2000 mg/kg bw.

Executive summary:

In this study performed according to OECD TG 401 guideline and GLP principles, 10 rats (5 males and 5 females) were administered with the substance at a dose level of 2000 mg/kg bw. None of the animals died. No abnormal clinical signs were observed. Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article dependent findings. Based on the results in this study, the acute oral LD50 for the substance in male and female rats was determined to be >2000 mg/kg bw.