2,6-dimethylheptan-4-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-11-14 to 1994-11-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

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

Constituent 1

Reference substance name:

2,6-dimethylheptan-4-one

EC Number:

203-620-1

EC Name:

2,6-dimethylheptan-4-one

Cas Number:

108-83-8

Molecular formula:

C9H18O

IUPAC Name:

2,6-dimethylheptan-4-one

Specific details on test material used for the study:

- Name of test material (as cited in study report): DIBK (Diisobutyl Ketone)
- Physical state: Clear liquid
- Analytical purity: 95.6%
- Lot/batch No.: 02264 00010

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Barriered Animal Breeding Unit, Zeneca Pharmaceuticals, Alderley Park, Macclesfield, Cheshire, UK
- Age at study initiation: 7 weeks
- Weight at study initiation: Males weighed 241-255g and the females weighed 180-182g
- Fasting period before study: Overnight prior dosing
- Housing: In suspended cages (26.5cm x 50.0cm x 20.7cm). The cages were made of stainless steel, with one solid sheet side and a mesh front, floor, rear and remaining side. The sexes were housed separately with a maximum of five rats per cage.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2
- Humidity (%): 45±15
- Air changes (per hr): 25-30/h
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10mL/kg bw

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 and weighing: The animals were observed for signs of systemic toxicity once within 2 hours of dosing and again between 4 and 7 hours after dosing. Subsequent observations were made once daily, or twice daily whenever there were significant signs of toxicity, up to day 15. The animals were weighed on the day before dosing (day -1), the day of dosing (day 1) and days 3, 4, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

There were no mortalities

Clinical signs:

other: Signs of slight and non-specific systemic toxicity including piloerection, sides pinched in (slight indentation in the sides of the abdomen) and urinary incontinence were observed in female rats. No signs of systemic toxicity were evident in male rats.

Gross pathology:

Pelvic dilatation of the kidney was observed in one male and pale areas of the lung was observed in one female. These are common spontaneous findings in rats of this age and strain and and are considered not to be treatment related.

Any other information on results incl. tables

The acute oral median lethal dose LD50 of Diisobutyl Ketone (DIBK) was estimated to be in excess of 2000mg/kg to male and female rats. According to DSD and CLP, DIBK has not to be classified.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of DIBK in rats is greater than 2000 mg/kg. Hence, no classification for acute oral toxicity is required according to EU criteria.