undecan-2-one; methyl nonyl ketone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was performed between 27 March 2002 and 16 April 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is from study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Undecan-2-one

EC Number:

203-937-5

EC Name:

Undecan-2-one

Cas Number:

112-12-9

Molecular formula:

C11H22O

IUPAC Name:

undecan-2-one

Test material form:

liquid

Remarks:

clear, colourless

Details on test material:

SOURCE OF TEST MATERIAL
- Batch No.of test material: EM97160115
- Expiration date of the lot/batch: 27 January 2018
- Purity test date: 07/07/2016

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- batch No.of test material: 05500109421007
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: test material was used as supplied
OTHER SPECIFICS:
- clear colourless liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: between 198 and 212 g
- Fasting period before study: overnight
- Housing: 3 per cage (solid-floor polypropylene furnished with woodflakes)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
The substance was administered undiluted.
MAXIMUM DOSE VOLUME ADMINISTERED: 2000 mg/kg

Doses:

2000 mg/kg

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: ½, 1, 2 and 4 hours after dosing and thereafter once daily
for fourteen days.
- Necropsy of survivors performed: yes
- Other examinations performed: signs of toxicity, bodyweights, clinical signs, examination major organs

Statistics:

An estimation of the acute oral median lethal dose (LD50) of the test material was made by using mortality data.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

One animal was found dead one day after dosing.

Clinical signs:

other: other: Signs of systemic toxicity included lethargy, decreased respiratory rate, laboured respiration and ataxia. All animals showed a hunched posture. The surviving animals recovered one or two days after dosing.

Gross pathology:

There were no abnormalities recorded for the animals which were sacrificed at the end of the study period. Necropsy on the animal which was found dead one day after dosing showed haemorrhagic lungs, patchy pallor of the liver and dark kidneys.

Applicant's summary and conclusion

Interpretation of results:

other: not classified Annex I of the CLP Regulation (1272/2008/EC).

Conclusions:

The oral median lethal dose (LD50) of Methyl Nonyl Ketone was determined in rats. The LD50 was >2500 mg/kg bw for female rats. Based on these results and according to the EU classification criteria outlined in Annex I of the CLP Regulation (1272/2008/EC) the compound does not need to be classified.

Executive summary:

Three female rats of the Sprague-Dawley CD strain were treated by oral gavage administration of Methyl Nonyl Ketone (undiluted) at a dose level of 2000 mg/kg bw. This was followed by a second group of three females which were treated with the same dose. The rats were observed for 14 days following dosing after which surviving animals were sacrificed and examined. Mortality and clinical signs were recorded. Signs of systemic toxicity included lethargy, decreased respiratory rate, laboured respiration and ataxia. All animals showed a hunched posture up to the 1st day after exposure. All surviving animals had completely recovered by 48 hours after dosing. One animal was found dead one day after dosing. The Oral Median Lethal Dose (LD50) were determined to be >2500 mg/kg bw. Based on these results and according to the EU classification criteria outlined in Annex I of the CLP Regulation (1272/2008/EC) the compound does not need to be classified.