2,4-dimethylpentan-3-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance (6400, 5000, 4500, 4000, 3200 µL/kg via an emulsion containing 30 % test substance). The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observation period also were subjected to necropsy.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,4-dimethylpentan-3-one

EC Number:

209-294-7

EC Name:

2,4-dimethylpentan-3-one

Cas Number:

565-80-0

Molecular formula:

C7H14O

IUPAC Name:

2,4-dimethylpentan-3-one

Test material form:

liquid

Details on test material:

- Name of test material (as cited in report): 2,4-Dimethylpentanon-3 / Diisopropyl keton
- Physical state: liquid

Specific details on test material used for the study:

- Name of test material (as cited in report): 2,4-Dimethylpentanon-3 / Diisopropyl keton
- Physical state: liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Gassner

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation (mean): Males 216 g, females 179 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

Aquatic emulsion with CMC and 2-3 drops Cremophor EL

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 % v/v

MAXIMUM DOSE VOLUME APPLIED: 6400 µL/kg

Doses:

6400, 5000, 4500, 4000, 3200 µL/kg (Conc. 30 %)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Other examinations performed: clinical signs, body weight

Statistics:

LD50 calculation according to LITCHFIELD und WILCOXON

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 645 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: based on a relative density of 0.81

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4.5 mL/kg bw

Based on:

act. ingr.

Mortality:

At 6400 µL/kg bw: 4/5 male and 3/ female animals died within 1 hour after dosing. All male animals were dead within 7 days and all female animals within 48 hours.
At 5000 µL/kg bw: 1/5 male and 1/5 female animals died within 24 hours after dosing. All male animals and 4/5 female animals were dead within 7 days. The last surviving female animal died in the last week of observation (within 14 days).
At 4500 µL/kg bw: 1 male animal died within the 14 day observation period. 1/5 female animals died with 48 hours after dosing and 4/5 died within 7 days after dosing. The last surviving female animal died in the last week of observation (within 14 days).
4000 µl/kg bw: no mortality occurred
3200 µl/kg bw: no mortality occurred

Clinical signs:

other: Immediately after application accelerated breathing was observed. Depending on the dosage, 1-40 minutes later tumbling, ragged breathing, crouching position, occasionally prone position and apathy was observed. After some hours apathy, irregular breathin

Gross pathology:

Animals which died of exposure:
6400 µL/kg bw: Acute dilatation of the heart. Dilation of the stomach (slight) containing thin pulpy contents or bloody ulcerations. Slight diarrhea contents in the intestines or hematised content of the intestines. Yellow gray discoloration of the liver, combined with dilation of the right atrium. General degeneration of the liver. Nephrosis
5000 µL/kg bw: Acute congestive hyperemia. Substance penetration through the stomach as well as Bloody ulcerations., Poor coagulation of the blood. Acute dilatation of the heart. Brightened liver and Toxic liver dystrophy, Toxic nephrosis of the liver (icm Yellow gray discoloration). Hematised content of the intestines. Partly infarctoid blood-fill, partly stain-faced with odematization of the lungs
4500 µL/kg bw: Acute dilatation of the heart. Yellow gray discoloration of the liver. Degeneration of the Kidneys. Total empty stomach-intestinal canal, distended filled with gas. Strong emaciation.

Animals which were necropsied after observation period.
4000 µL/kg bw: Total loss of perirenal adipose tissue. Edema of the for-stomach. Animals largely emaciated.
3200 µL/kg bw: no effects observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met