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Description of key information

Acute oral toxicity:

LD50 was considered t be > 5000 mg/kg bw when rats were treated with nonan-2-one orally.

Acute dermal toxicity:

LD50 was considered t be > 5000 mg/kg bw when rabbits were treated with nonan-2-one by dermal application.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer-reviwed journal
Qualifier:
according to guideline
Guideline:
other: No data
Principles of method if other than guideline:
Acute oral toxicity study of nonan-2-one in rats
GLP compliance:
no
Test type:
other: No data
Limit test:
yes
Specific details on test material used for the study:
- Name of test material: 2-Nonanone (nonan-2-one )
- IUPAC name: nonan-2 -one
- Molecular formula: C9H18O
- Molecular weight: 142.24g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data available
- Impurities (identity and concentrations): No data
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
5000 mg/kg
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
No data available
Statistics:
No data available
Preliminary study:
No data
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No 50% mortality observed
Mortality:
Death of one out of ten rats was observed at 5000 mg/kg bw
Clinical signs:
No data available
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
not classified
Conclusions:
LD50 was considered t be > 5000 mg/kg bw when rats were treated with nonan-2-one orally.
Executive summary:

In a acute oral toxicity study, 10 rats were treated with nonan-2-one in the concentration of 5000 mg/kg bw orally. Death of one out of ten rats was observed at 5000 mg/kg bw. Therefore, LD50 was considered t be > 5000 mg/kg bw when rats were treated with nonan-2-one orally.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from peer- reviewed journal

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer -reviewed journal
Qualifier:
according to guideline
Guideline:
other: No data
Principles of method if other than guideline:
Acute dermal toxicity study of nonan-2-one in rabbits
GLP compliance:
no
Test type:
other: No data
Limit test:
yes
Specific details on test material used for the study:
- Name of test material: 2-Nonanone (nonan-2-one )
- IUPAC name: nonan-2 -one
- Molecular formula: C9H18O
- Molecular weight: 142.24g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data available
- Impurities (identity and concentrations): No data
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data available
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
No data available
Duration of exposure:
24 hour
Doses:
5000 mg/kg
No. of animals per sex per dose:
7
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: no data
- Frequency of observations and weighing:no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: mortality, clinical signs and gross pathology were observed.
Statistics:
No data available
Preliminary study:
No data available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed in all seven animals.
Mortality:
No mortality was observed in all seven animals.
Clinical signs:
Irritation was observed in treated rabbits at 5000 mg/kg bw
Body weight:
No data available
Gross pathology:
scaly skin was observed in treated rabbits at 5000 mg/kg bw
Other findings:
No data available
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
LD50 was considered t be > 5000 mg/kg bw when rabbits were treated with nonan-2-one by dermal application.
Executive summary:

In a acute oral toxicity study, 7 rabbits were treated with nonan-2-one in the concentration of 5000 mg/kg bw orally. 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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from peer- reviewed journal

Additional information

Acute oral toxicity:

In different studies, nonan-2-one has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments and estimated data in rodents, i.e. most commonly in mice and rats for nonan-2-one. The predicted data using the OECD QSAR toolbox has also been compared with the experimental studies.

In a study conducted by Morenoet al(Food and Chemical Toxicology Volume 26, Issue 4, 1988, Pages 393), 10 rats by using nonan-2-one in the concentration of 5000 mg/kg bw orally. Death of one out of ten rats was observed at 5000 mg/kg bw. Therefore, LD50 was considered t be > 5000 mg/kg bw when rats were treated with nonan-2-one orally.

In another prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the acute oral toxicity was estimated for nonan-2-one. LD50 value was estimated to be 4050 mg/kg bw when Wistar male and female rats orally treated with nonan-2-one. 

Also it is further supported with prediction done by using Danish EPA Model, LD50 was estimated to be 5300 mg/kg bw when mice were treated nonan-2-one orally.  

In addition study given by HPV Challenge Program (2007), acute oral toxicity was evaluated in 4 ddY male mice by using nonan-2-one in four concentrations orally by gavage in olive oil. Mice were pre-treated with an intraperitoneal injection of olive oil. 50 % mortality observed at 7879 mg/kg bw. Therefore, LD50 was considered to be 7879 mg/kg bw (5538-9552 mg/kg) when 4 ddY male mice were treated nonan-2-one in Olive Oil orally by gavage.  

Thus, based on the above studies and predictions on nonan-2-one, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus comparing this value with the criteria of CLP regulation, 4-methylphenyl acetate can be “Not classified” for acute oral toxicity.

Acute dermal toxicity: New

In different studies, nonan-2-one has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments and estimated data in rodents, i.e. most commonly in rabbits for nonan-2-one along with the study available on structurally similar read across substance 2-Undecanone (CAS no: 112-12-9) and 6-Methyl-2-heptanone (CAS no: 928-68-7). The predicted data using the OECD QSAR toolbox has also been compared with the experimental studies.

In an acute oral toxicity study by Morenoet al(Food and Chemical Toxicology Volume 26, Issue 4, 1988, Pages 393), 7 rabbits by using nonan-2-one in the concentration of 5000 mg/kg bw orally. 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.

In another prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the acute oral toxicity was estimated for nonan-2-one. LD50 value was estimated to be 5012 mg/kg bw for New Zealand White male and female rabbits. 

Also it is further supported study given by HPV Challenge Program (2007) on structurally similar the read across substance 2-Undecanonein (CAS no: 112-12-9), 4 rabbits were treated with 2-Undecanone in the concentration of 5000 mg/kg bw by dermal application. No mortality was observed in treated rabbits at 5000mg/kg bw. Therefore, LD50 was considered to be >5000mg/kg bwwhen rabbits were2-Undecanoneby dermal application.

In above similar source study given for another structurally similar read across substance 6-Methyl-2-heptanone (CAS no: 928-68-7), 6 rabbits were treated with 6-Methyl-2-heptanone in the concentration of 5000 mg/kg bw by dermal application. One animal died on day 9. Therefore, LD50 was considered to be >5000 mg/kg bw when 6 rabbits were 6-Methyl-2-heptanone by dermal application. 

Thus, based on the above studies and predictions on nonan-2-one and its read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, nonan-2-one can be “Not classified” for acute dermal toxicity.

Justification for classification or non-classification

Based on the above studies and predictions on nonan-2-one and its read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, nonan-2-one can be “Not classified” for acute oral and dermal toxicity.