5-methyl-5-phenylhexan-3-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was conducted between 7 December 1994 and 27 December 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Reliability 2 is assigned because the study was used for read-across.

Justification for type of information:

The present information is used for read across to Damascol.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

February 24, 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

July 31, 1992

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-methyl-4-phenylpentan-2-one

EC Number:

231-007-9

EC Name:

4-methyl-4-phenylpentan-2-one

Cas Number:

7403-42-1

Molecular formula:

C12H16O

IUPAC Name:

4-methyl-4-phenylpentan-2-one

Test animals

Species:

rat

Strain:

other: Hsd/Win: WU

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Harlan Winkelmann GmbH
- Age at study initiation: no information available
- Weight at study initiation: males: 201-237 g, females: 177-203 g
- Fasting period before study: ~16 h
- Housing: collective housing up to a maximum of 5 animals per cage (Makrolon type III)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3
- Humidity (%): 30-70
- Air changes (per hr): no information available
- 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: 2.02 mL/kg (for 2000 mg/kg bw dose)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed 10 minutes, 1, 2 and 6 hours after application and thereafter daily
- Necropsy of survivors performed: yes, at the end of the observation period the animals were killed by CO2 asphyxiation, necropsied and subjected to examination for gross pathological changes.
- Body weights: Individual body weights were recorded immediately before treatment (day 1) and then on the 7th and 14th day of the observation period.

Results and discussion

Preliminary study:

None of the animals died 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:

In some animals abnormal clinical signs were observed up to 24 hours after administration of the test substance. These signs included abnormal gait, squatting position, reduced activity, piloerection and decreased respiratory rate.

Body weight:

No treatment related changes were recorded in the body weights of the animals during the study period.

Gross pathology:

No abnormalities observed.

Applicant's summary and conclusion

Interpretation of results:

other: not classified for actute oral toxicity

Remarks:

Based on CLP criteria (EC 1272/2008 and its amendments)

Conclusions:

The acute oral LD50 for Vetikon in male and female rats was determined to be >2000 mg/kg bw. Based on this result, the test material does not need to be classified for acute oral toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Executive summary:

In this study, 10 rats (5 males and 5 females) were administered Vetikon at a single dose level of 2000 mg/kg bw by oral gavage. The study was performed according to OECD guideline 401. A preliminary study was conducted with 2 female rats for range finding; in this study there were no deaths recorded. During the main study there were also no mortalities recorded. Clinical signs were observed up to 24 hours after administration. These effects included abnormal gait, squatting position, reduced activity, piloerection and decreased respiratory rate. No body weight or gross pathology abnormalities were detected. The acute oral LD50 for Vetikon in male and female rats was determined to be >2000 mg/kg bw. Based on this result, Vetikon does not need to be classified for acute oral toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).