6-methylhept-5-en-2-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1974

Report date:

1974

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:

Study was performed acc. internal BASF method, which was in part equivalent to OECD Guideline 401

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

6-methylhept-5-en-2-one

EC Number:

203-816-7

EC Name:

6-methylhept-5-en-2-one

Cas Number:

110-93-0

Molecular formula:

C8H14O

IUPAC Name:

6-methylhept-5-en-2-one

Details on test material:

- Name of test material (as cited in study report): 6-Methyl-5-hepten-2-one
- Analytical purity: 98 %

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gassner
- Weight at study initiation: average 172 g (females) and 194 g (males)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2, 16, and 30%
- Amount of vehicle (if gavage): 10 ml/kg bw
- Other: vehicle solution contained 2-3 drops of cremophor EL (as solubilizer)

Doses:

0.2, 1.6, 3.2, 4.0, 5.0 and 6.4 ml/kg bw = (calculated with density of 0.85 at 20 °C): 170, 1360, 2720, 3400, 4250 and 5540 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: not applicable

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 3 570 mg/kg bw

Mortality:

5540 mg/kg bw: 5/5 males and 4/5 females died within 24 hrs, 1 additional female died within 7 days 4250 mg/kg bw: 4/5 males and 2/5 females died within 24 hrs 3400 mg/kg bw: 0/5 males and 0/5 females died within 7 days 2720 mg/kg bw: 0/5 males and 1/5 females died within 24 hrs 1360 mg/kg bw: 2/5 males and 0/5 females died within 24 hrs 170 mg/kg bw: 0/5 males and 0/5 females died within 7 days

Clinical signs:

other: 5540 mg/kg bw: Abdominal and lateral position, atonia, apathy, severe dyspnoea 4250 - 1360 mg/kg bw: abdominal position, apathy, atonia, gasping, smeared fur, animals were without clinical symptoms after 5 days 170 mg/kg bw: atonia, gasping, after 1 day

Gross pathology:

In animals that died due to substance application: 5540 - 1360 mg/kg bw: acute heart dilatation, congestive hyperemia; greyish discoloration of liver and kidneys In animals that were sacrificed after post observation period: No abnormalities detected in any group

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

based on CLP Criteria

Conclusions:

Under the conditions of the test, the oral LD50 was determined to be 3570 mg/kg bw. Therefore, the substance does not need to be classified for acute toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Executive summary:

An acute oral fixed dose study was performed, according to a internal BASF method, which was in  part equivalent to OECD Guideline 401. Sprague Dawley (Gassner) rats, 5 male and 5 female per dose, were exposed to doses of 170, 1360, 2720, 3400, 4250 and 5540 mg/kg bw (density at 200C of 0.85 g/ml) by oral gavage. Animals were observed for 7-days after dosing, all symptoms and deaths were recorded. Necropsy was performed in animals that died due to substance application. Under the conditions of the test, the oral LD50 was estimated to be ca. 3570 mg/kg bw after 7 days for males and females.

This present data on acute oral toxicity is > 2000 mg/kg bw, therefore, the substance does not need to be classified for acute toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).