Pentan-3-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1969

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is comparable to OECD 401 with acceptable restrictions due to reduced reporting in times before GLP

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Reference 2

Reference Type:

other company data

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Pentan-3-one

EC Number:

202-490-3

EC Name:

Pentan-3-one

Cas Number:

96-22-0

Molecular formula:

C5H10O

IUPAC Name:

pentan-3-one

Details on test material:

- Name of test material (as cited in study report): Diaethylenketon
- Physical state: liquid
- Analytical purity: 99.8 %

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gassner
- Weight at study initiation: males 228+- 21 g; females 185+- 17 g

ENVIRONMENTAL CONDITIONS
- not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous emulsion containing Traganth

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2; 20; 30 %

MAXIMUM DOSE VOLUME APPLIED: 21.4 mL/kg bw

Doses:

200, 1600 3200, 4000, 5000 and 6400 µL/Kg bw (corresponding to ca. 160, 1300, 2590, 3240, 4050 and 5180 mg/kg bw if calculated with a density of 0.81 g/mL)

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing:
weighing was only at the beginning of the study for dose calculation.
Observation of clinical signs was several times on the day of administration and once daily
afterwards with the exception of weekends and on holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 900 mg/kg bw

Remarks on result:

other: original value reported: 3600 µL/kg bw, calculated with a density of 0.81 g/mL

Mortality:

200 and 1600 µL/kg bw: 0/20 animals
3200 µL/kg bw: 3/20 animals died within 24 h post applicationem
4000 µL/kg bw: 17/20 animals died; 14 within 24 h post applicationem and 16 within 48 h p.a.
5000 µL/kg bw: 20/20 animals died within 24 h post applicationem
6400 µL/kg bw: 18/20 animals died; 17 within 24 h post applicationem and 18 within 48 h p.a.

Clinical signs:

other: 200 µL/kg bw: calm behaviour; reversible within day 6 p.a. 1600 µL/kg bw: severe staggering, reddened eyes and slightly accelerated respiration; reversible within day 6 p.a. 3200 -6400 µL/kg bw: directly after application severe staggering, abdominal pos

Gross pathology:

Animals that died: Intense acetone-like odor of the organs, lung filled with blood, serous blurred snouts, atonic gastrointestinal tract
Sacrificed animals: nothing abnormal found

Applicant's summary and conclusion

Executive summary:

In this acute oral toxicity study (BASF AG, Department of Toxicology, 1969), groups of young adult rats (10/sex) were given single oral doses of Diethyl ketone (99.8 % a.i.) in an aqueous emulsion containing Traganth (concentration in vehicle: 2; 20; 30 %) at doses of 200, 1600, 3200, 4000, 5000 and 6400 µL/kg bw (corresponding to ca. 160, 1300, 2590, 3240, 4050 and 5180 mg/kg bw if calculated with a density of 0.81 g/mL).

Animals were observed for 7 days.

The oral LD₅₀ value for males and females was calculated to be 2900 mg/kg bw.