undecan-2-one; methyl nonyl ketone

Endpoint summary

Description of key information

Acute oral toxicity:

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.

Acute inhalation toxicity:

The acute inhalation toxicity dose (LC50) was considered to be >5430 mg/m³, when rats were exposed to Methyl nonyl ketone via inhalation route.

Acute dermal toxicity:

The lethal concentration (LD50) value for acute dermal toxicity test was considered to be >5000 mg/kg bw,when rabbits were treated with test chemical Methyl nonyl ketone via dermal route.

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

Justification for type of information:

Data is from study report

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

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

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

Quality of whole database:

Data is from study report and klimish 1.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

The study is from a secondary literature

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

not specified

Test type:

fixed concentration procedure

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

not specified

Route of administration:

inhalation

Type of inhalation exposure:

not specified

Vehicle:

not specified

Details on inhalation exposure:

not specified

Concentrations:

5430 mg/m³

No. of animals per sex per dose:

not specified

Control animals:

not specified

Details on study design:

not specified

Key result

Sex:

not specified

Dose descriptor:

LC50

Effect level:

> 5 430 mg/m³ air

Based on:

test mat.

Mortality:

No mortality was observed

Clinical signs:

other:

Body weight:

not specified

Interpretation of results:

other: Not classified

Conclusions:

The acute inhalation toxicity dose (LC50) was considered to be >5430 mg/m³, when rats were exposed to Methyl nonyl ketone via inhalation route.

Executive summary:

Acute inhalation toxicity study was performed in rats using test chemical Methyl nonyl ketone (CAS no.: 112 -12 -9, E.C. no.: 203 -937 -5). Rats were treated at a dose concentration of 5430 mg/m³. Animals were further observed for clinical signs of toxicity and mortality. No mortality was observed at dose 5430 mg/m³. Hence, the LC50 value was considered to be >5430 mg/m³, when rats were treated with test chemical Methyl nonyl ketone. The test chemical can be considered as "Not classified" according to the CLP.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

5 430 mg/m³ air

Quality of whole database:

Data is from secondary literature and klimish 4.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

Data is from publication

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

fixed dose procedure

Species:

rabbit

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

Not specified

Type of coverage:

not specified

Vehicle:

not specified

Details on dermal exposure:

not specified

Duration of exposure:

not specified

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

4 animals/sex/dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed for mortality and systemic effects over a 14 day period.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed at dose 5000 mg/kg bw

Clinical signs:

other: not specified

Gross pathology:

not specified

Interpretation of results:

other: Not classified

Conclusions:

The lethal concentration (LD50) value for acute dermal toxicity test was considered to be >5000 mg/kg bw,when rabbits were treated with test chemical Methyl nonyl ketone via dermal route.

Executive summary:

Acute dermal toxicity study was performed in rabbits using test chemical Methyl nonyl ketone (CAS no.: 112 -12 -9, E.C. no.: 203 -937 -5). 4male and 4female rabbits were treated at a dose concentration of 5000mg/kg bw. Animals were further observed for clinical signs of toxicity and mortality. No mortality was observed at dose 5000 mg/kg bw. Hence, the LD50 value was considered to be >5000mg/kg bw,when rabbits were treated with test chemical Methyl nonyl ketone via dermal route. The test chemical can be considered as "Not classified" according to the CLP.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Data is from journal and klimish 2.

Additional information

Acute oral toxicity:

1. 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.

2. Acute oral toxicity study was performed in rats using testchemicalMethyl nonyl ketone (CAS no.: 112 -12 -9, E.C. no.: 203 -937 -5). 10 male and10 female rats were treated at a dose concentration of 5000mg/kg bw. Animals were further observed for clinical signs of toxicity and mortality.No mortality was observed at dose5000 mg/kg bw.Hence, the LD50 value was considered to be >5000mg/kg bw,when rats were treated with test chemical Methyl nonyl ketone. The test chemical can be considered as "Not classified" according to the CLP.

3. Acute oral toxicity study was performed in rats using testchemicalMethyl nonyl ketone (CAS no.: 112 -12 -9, E.C. no.: 203 -937 -5). Rats were treated at a dose concentration of 5000mg/kg bw. Animals were further observed for clinical signs of toxicity and mortality. 50%mortality was observed at dose5000 mg/kg bw.Hence, the LD50 value was considered to be 5000mg/kg bw,when rats were treated with test chemical Methyl nonyl ketone. The test chemical can be considered as "Not classified" according to the CLP.

4. Acute oral toxicity study was conducted by using Methyl nonyl ketone (CAS no: 112-12-9) in group of 4 male ddY mice at the concentration of 19481 (11937-31810) mg/kg. The test substance was dissolved in olive oil and administered via oral gavage route. 50% mortality was observed. Hence, LD50 value was considered to be 19481 mg/kg with 95% confidence limit of 11937-31810 mg/kg, when group of 4 male ddY mice were treated with Methyl nonyl ketone via oral gavage route. The test chemical can be considered as "Not classified" according to the CLP.

5. In a acute oral toxicity study, 10 rats were treated with the read across substance nonan-2-one (CAS no.: 821 -55 -6) at the concentration of 5000 mg/kg bw orally. Animals were then observed for clinical signs of toxicity and mortality. Death of one out of ten rats was observed at 5000 mg/kg bw. Therefore, LD50 was considered to be > 5000 mg/kg bw when rats were treated with nonan-2 -one orally. Hence the test substance was considered to be under "Not classified" according to the CLP criteria.

6. In a acute oral toxicity study,rats were treated with the read across substance Octyl Acetate (CAS no.: 112 -14 -1) at the concentration of 5000 mg/kg bw orally. Animals were further observed for clinical signs of toxicity and mortality. 50% mortality was observed in treated rats at 5000 mg/kg bw. Therefore,LD50 was considered to be approximately5000 mg/kg bw when rat were treated with Octyl Acetate orally. Hence, the read across substance can be considered under "Not classified", as per the CLP criteria. 

Acute inhalation toxicity:

1. Acute inhalation toxicity study was performed in rats using testchemicalMethyl nonyl ketone (CAS no.: 112 -12 -9, E.C. no.: 203 -937 -5). Rats were treated at a dose concentration of 5430mg/m³. Animals were further observed for clinical signs of toxicity and mortaliy.No mortality was observed at dose5430mg/m³.Hence, the LC50 value was considered to be >5430mg/m³, when rats were treated with test chemical Methyl nonyl ketone. The test chemical can be considered as "Not classified" according to the CLP.

2. Acute inhalation toxicity study was performed in mouse using testchemicalMethyl nonyl ketone (CAS no.: 112 -12 -9, E.C. no.: 203 -937 -5). Mouse were treated at a dose concentration of 102000mg/m³. Animals were further observed for clinical signs of toxicity and mortaliy. 50%mortality was observed at dose 102000mg/m³.Hence, the LC50 value was considered to be 102000mg/m³, when mouse were treated with test chemical Methyl nonyl ketone. The test chemical can be considered as "Not classified" according to the CLP.

3. In an acute inhalation toxicity study, guinea pigs were exposed to test chemical in the concentration of 1300 mg/L in a saturated atmosphere for 14 hours. No mortality was observed in treated guinea pig at 1300 mg/L and nasal irritation developed immediately after the guinea-pig was exposed to an essentially saturated atmosphere (1300 mg/l). This was followed by muscular weakness after exposure for approximately 10 hr and by coma after approximately 12 hr.No mortality was observed in the guinea pigs when exposed to 1300 mg/L of the test chemical for 14 hours. Hence, the acute inhalation LC50 value can be considered to be greater than 1300 mg/L and can be considered under "Not classified" as per the CLP guidelines.

Acute dermal toxicity:

1. Acute dermal toxicity study was performed in rabbits using testchemicalMethyl nonyl ketone (CAS no.: 112 -12 -9, E.C. no.: 203 -937 -5). 4male and 4female rabbits were treated at a dose concentration of 5000mg/kg bw. Animals were further observed for clinical signs of toxicity and mortality.No mortality was observed at dose5000 mg/kg bw.Hence, the LD50 value was considered to be >5000mg/kg bw,when rabbits were treated with test chemical Methyl nonyl ketone via dermal route. The test chemical can be considered as "Not classified" according to the CLP.

2. Acute dermal toxicity study was performed in rabbits using testchemicalMethyl nonyl ketone (CAS no.: 112 -12 -9, E.C. no.: 203 -937 -5). Male and female rabbits were treated at a dose concentration of 2000mg/kg bw. Animals were further observed for clinical signs of toxicity and mortality. No mortality was observed at dose 2000 mg/kg bw.Hence, the LD50 value was considered to be >2000mg/kg bw, when rabbits were treated with test chemical Methyl nonyl ketone via dermal route. The test chemical can be considered as "Not classified" according to the CLP.

3. In a acute oral toxicity study, 7 rabbits were treated with read across substance nonan-2 -one (CAS no.: 821 -55 -6) at the concentration of 5000 mg/kg bw orally. Animals were observed for signs of toxicity. No mortality were observed in treated rabbits at 5000 mg/kg bw. Irritation and scaly skin was observed in treated rabbits at 5000 mg/kg bw. Therefore, LD50 was considered t be > 5000 mg/kg bw when rabbits were treated with nonan-2 -one by dermal application. Hence, the test substance was considered to be "Not classified", as per CLP guidelines.

4. The study was designed and conducted to determine the acute dermal toxicity profile of the test chemical as per OECD Guideline 402 (Acute Dermal Toxicity) in Sprague Dawley rats. In the dose range finding study a single dose of 200 mg/kg body weight of the test item was administered to 1 female animal. No death or clinical signs of toxicity was observed during first 48 hours, hence, additional 1 female animal was administered with the dose of 1000 mg/kg body weight. Administration of 1000 mg/kg body weight did not reveal any clinical signs of toxicity or death during first 48 hours, hence, additional 1 female animal was administered at the dose of 2000 mg/kg body weight. Administration of 2000 mg/kg body weight did not reveal any clinical signs of toxicity or death during first 48 hours. As the dose range finding study revealed no mortality or clinical signs at the maximum dose of 2000 mg/kg, the main study was initiated with two additional animals. The animals were administered with a dose of 2000 mg/kg body weight in sequential manner at 48 hours intervals.Animals from dose range finding study treated at the dose levels of 200 mg/kg, 1000 mg/kg and 2000 mg/kg and animals from main study treated at the dose level of 2000 mg/kg exhibited normal body weight gain and revealed no clinical signs of toxicity or mortality during the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment.It was concluded that the acute dermal median lethal dose (LD50) of the given test chemical, when administered to female Sprague Dawley rats was considered to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not classify as an acute dermal toxicant. CLP Classification: “Not classified”.

5. In a acute dermal toxicity study,rabbits were treated with read across substance Octyl Acetate (CAS no.: 112 -14 -1) at the concentration of 3000 mg/kg bw dermally. Animals were further observed for cinical signs of toxicity and mortality. No mortality observed in treated rabbits at 3000 mg/kg bw. Therefore,LD50 was considered to be > 3000 mg/kg bw when rabbits were treated with Octyl Acetate dermally. Hence, the substance can be considered under "Not classified" according to the CLP.

Justification for classification or non-classification

Based on the above studies for the test chemical, it can be concluded that LD50 value is >2000 mg/kg bw for acute oral, inhalation and dermal toxicity. Thus, comparing these values with the criteria of CLP regulation, the given test chemical can be classified as “Not classified” for acute oral, inhalation and dermal toxicity.