6,10-dimethylundecan-2-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

1996

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

1998

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

1996

GLP compliance:

yes (incl. QA statement)

Remarks:

Experimental Toxicology and Ecology BASF Aktiengesellschaft

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

6,10-dimethylundecan-2-one

EC Number:

216-509-8

EC Name:

6,10-dimethylundecan-2-one

Cas Number:

1604-34-8

Molecular formula:

C13H26O

IUPAC Name:

6,10-dimethylundecan-2-one

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Tetrahydrogeranylaceton
- Substance No.: 01/0275-1
- Batch-Nr.: B 633
- Purity: 97.5 area% (GC)
- Date of production: 17 Oct 2000
- Substance type: Liquid / colourless - clear

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: BASF, Batch No. B633
- Date of production: 2000-10-17
- Purity: 97.49 FI.-% (GC)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refrigerator
- Stability under test conditions: The stability of the test substance over the study period was confirmed by analysis.
- Homogeneity: homogeneous
- Physical state / appearance: liquid / colourless - clear

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance preparation was produced for each dose group shortly before administration in olive oil Ph.Eur./DAB by stirring with a magnetic stirrer.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Wistar / CrIGlxBrIHan:WI
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, 97633 Sulzfeld
- Animal identification: Individual identification by cage cards and tail marking
- Age at study initiation: Young adult animals (male animals approx. 8 - 12 weeks, female animals approx. 14 -18 weeks)
- Weight at study initiation: mean 231 g (male), 192 g (female)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single housing in stainless steel wire mesh cages, type DK-111 (Becker & Co., Castrop-Rauxel, FRG)
- Diet (e.g. ad libitum): Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40g/100 ml
- Amount of vehicle (if gavage): 5 ml/kg bw
- Justification for choice of vehicle: Olive oil Ph.Eur/DAB had to be used to ensure homogeneityof the preparation.

MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance and its composition, no pronounced acute oral toxicity was expected. Therefore, a starting dose of 2,000 mg/kg body weight (limit test) has been chosen in the first step with 3 female animals. As none of those animals died, 2,000 mg/kg body weight were administered to 3 male animals in a second step. Because no mortality occurred either the study fulfilled the criteria for a limit test and was terminated.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and at the end of the study.
- Recording of signs and symptoms several times on the day of administration: at least once each workday for the individual animals
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight; Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other:

Remarks:

no mortality observed

Mortality:

No mortality noted

Clinical signs:

Signs of toxicity noted in the females of the 2,000 mg/kg dose group comprised poor general state, dyspnoea, apathy and piloerection and were observed during hour 5 after administration.

Body weight:

The mean body weights of the dose groups increased throughout the study period.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (3 males and 3 females) examined at termination of the study.

Any other information on results incl. tables

Body weight:
The mean body weights of the dose groups increased throughout the study  period.
Mean body weight during the observation period:
             male (g)       female (g)
---------------------------------------
day 0         231              197
day 7         260              212
day 14        289              218

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study the median lethal dose of the test substance after oral administration was found to be greater than 2.000 mg/kg body weight for male and female rats.

Executive summary:

The study was performed to assess the acute toxicity following oral administration of the test substance in Wistar rats.

The study procedure was based on the OECD, EU and US EPA OPPTS guidelines.

Single doses of 2.000 mg/kg body weight of test material preparations in olive oil Ph.Eur./DAB were given to two dose groups of three fasted animals, each (males and females) by gavage in a sequential manner.

No mortality occured.

Clinical signs and findings in the female dose group comprised poor general state, dyspnoea, apathy and piloerection. Findings were observed during hour 5 after administration. No signs of toxicity were observed in the male dose group.

The mean body weights of the dose groups increased throughout the study period.

No macroscopic pathologic abnormalities were noted in the animals examined at the end of the observation period.