Registration Dossier

Administrative data

Description of key information

Acute toxicity, Oral (OECD 423): LD50 >2500 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:
The study was performed between 27 March 2002 and 16 April 2002.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
According to GLP
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
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
Species:
rat
Strain:
Sprague-Dawley
Remarks:
CD
Sex:
female
Details on test animals 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

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
The substance was administered undiluted.

MAXIMUM DOSE VOLUME APPLIED: 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.
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:
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.
Body weight:
All surviving animals showed the expected increase in body weight during the course of the study period.
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.
Interpretation of results:
other: not classified
Remarks:
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 500 mg/kg bw
Quality of whole database:
guideline study

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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) was 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.

Justification for classification or non-classification

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.