6-methylhept-5-en-2-one

Endpoint summary

Description of key information

Acute oral toxicity (similar to OECD TG 401): LD50 = 3570 mg/kg bw

Acute dermal toxicity (non-guideline study): LD50 >5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

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

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)

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

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

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).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

3 570 mg/kg bw

Quality of whole database:

Key study is comparable to guideline study with acceptable restrictions.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable study with limited documentation from secondary source which meets basic scientific principles.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Acute dermal toxicity test in rabbits

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

not specified

Sex:

not specified

Type of coverage:

not specified

Vehicle:

not specified

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: mortality and clinical signs

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

1/6 deaths occurred on day 9

 The present data on acute dermal toxicity do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a non-classification is warranted.

Interpretation of results:

other: not classified

Remarks:

based on CLP criteria

Conclusions:

Under the conditions of the test, the dermal LD50 was > 5000 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 dermal toxicity study was performed. Duration of observation period following administration: 14 days, mortality and clinical signs were examined.

Under the conditions of the test, the dermal LD50 was > 5000 mg/kg bw. Therefore, the criteria laid down in Annex I of the CLP Regulation (1272/2008/EC) are not fullfilled and the substance does not need to be classified for acute toxicity.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

The key study is an acceptable study with limited documentation from secondary source which meets basic scientific principles.

Additional information

Acute oral toxicity

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.

Acute dermal toxicity

An acute dermal toxicity study was performed. Duration of observation period following administration: 14 days, mortality and clinical signs were examined.

Under the conditions of the test, the dermal LD50 was >5000 mg/kg bw.

Justification for classification or non-classification

Based on the available data, Methylheptenone does not need to be classified for acute oral and dermal toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).