5-methylheptan-3-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1949

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented non-GLP study for several substances

Data source

Reference

Reference Type:

publication

Title:

Range-finding toxicity data: List III

Author:

Smyth HF. Jr, Carpenter CP., Weil CS

Year:

1949

Bibliographic source:

Journal. Ind. Hyg. and Tox, Issue 1 (31): p60, 1949

Materials and methods

Principles of method if other than guideline:

Groups of 5 male albinos rats were given a single dose of 3-heptanone by stomach tube until 2 dosages differing by a multiple of 10 were found, the first one killing some or all of the animals and the other killing some or no animals within 14 days. The chosen concentrations were in a geometric series.

GLP compliance:

no

Remarks:

Study performed before the introduction of GLP

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-Heptanone

IUPAC Name:

3-Heptanone

Constituent 2

Reference substance name:

Heptan-3-one

EC Number:

203-388-1

EC Name:

Heptan-3-one

Cas Number:

106-35-4

Molecular formula:

C7H14O

IUPAC Name:

heptan-3-one

Test animals

Species:

rat

Strain:

other: Sherman or Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

Rats weighing ca. 120 g.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

Geometric series of single doses such as 1, 2, 4 and 8 g/Kg body weight

No. of animals per sex per dose:

5

Control animals:

not specified

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

approximate LD50

Effect level:

2 760 mg/kg bw

Mortality:

Mortality was observed after oral dosing of 3-heptanone and was considered complete 14 days after dosing.

Clinical signs:

other: Not determined.

Gross pathology:

Not determined.

Any other information on results incl. tables

A fiducial range was also estimated and the LD50 values ranged from 2560 - 2980 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information according to EU GHS or dangerous substance directive Criteria used for interpretation of results: EU

Conclusions:

3-Heptanone is not toxic via an oral exposure according to the EU classification system

Executive summary:

Acute oral toxicity to rats of 3-heptanone was investigated in a single-dose oral toxicity study. Dosing was performed by oral gavage and mortality was observed for 14 days after dosage. Groups of 5 male animals were used per dose. The calculated LD50 for 3 -heptanone was 2760 mg/kg bw and thus above the classification threshold for acute oral toxicity of 2000 mg/kg bw according to Regulation (EC) 1272/2008 or Directive 67/548/EEC.