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Toxicological information

Acute Toxicity: oral

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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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969
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

Constituent 1
Chemical structure
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:
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 position, reddened eye, bloody snouts, sunken flanks, irregular respiration, reduced tonus and no defence reaction. Survivors of the 6400 and 3200 µL/kg bw groups showed calm behaviour, ruffled fur and squatting posture on the 4th and 5th day; findings were transient on day 7. Survivors of the 4000 µL/kg bw group were narcotic on days 2 and 3, followed by slow reversibility; almost completely reversible on day 8 p.a.
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.