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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

LD50 was considered to be 2800 mg/kg bw when mice were treated with Methyl nicotinate orally.

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:
weight of evidence
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 International Programme on Chemical Safety
Qualifier:
according to guideline
Guideline:
other: as below
Principles of method if other than guideline:
Acute oral toxicity of Methyl nicotinate in mice
GLP compliance:
not specified
Test type:
other: No data
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Methyl nicotinate
- Molecular formula (if other than submission substance): C7H7NO2
- Molecular weight (if other than submission substance): 137.137 g/mol
- Substance type: Organic
- Physical state: white solid powder
Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data available
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data available.
Doses:
2800 mg/kg bw
No. of animals per sex per dose:
No data available.
Control animals:
not specified
Details on study design:
No data available.
Statistics:
No data available.
Preliminary study:
No data available.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
2 800 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50 % mortality observed
Mortality:
50 % mortality was observed in rats at 2800 mg/kg bw
Clinical signs:
other: No data available.
Gross pathology:
No data available.
Other findings:
No data available.
Interpretation of results:
other: Not classified
Conclusions:
LD50 was considered to be 2800 mg/kg bw when mice were treated with Methyl nicotinate orally.
Executive summary:

In acute oral toxicity study, mice were treated with Methyl nicotinate orally in the concentration of 2800 mg/kg bw. 50 % mortality was observed in rats at 2800 mg/kg bw. Therefore, LD50 was considered to be 2800 mg/kg bw when mice were treated with Methyl nicotinate orally.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 800 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from Joint FAO/WHO Expert Committee on Food Additives

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

Acute oral toxicity:

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

In an experimental study given by Joint FAO/WHO Expert Committee on Food Additives (JECFA) (International Programme on Chemical Safety World Health Organization (IPCS), WHO FOOD ADDITIVES SERIES: 54, 2006), mice were treated with Methyl nicotinate orally in the concentration of 2800 mg/kg bw. 50 % mortality was observed in rats at 2800 mg/kg bw. Therefore, LD50 was considered to be 2800 mg/kg bw when mice were treated with Methyl nicotinate orally.

In another experimental study conducted by Nworguet al(Acta Poloniae Pharmaceutica - Drug Research, Vol. 64 No. 2 pp. 179-182, 2007), male and female mice were treated with Methyl nicotinate in the concentration of 1000, 2000, 3000 and 5000 mg/kg orally by gavage. 50 % mortality was observed in treated mice at 5000 mg/kg bw. Therefore, LD50 was considered to be 5000 mg/kg bw when male and female mice were treated with Methyl nicotinate orally by gavage.

Also it is supported by estimation done by using Danish QSAR , 50 % mortality observed at 3300 mg/kg bw . Therefore, estimated LD50 was considered to be 3300 mg/kg bw when rat were treated with Methyl nicotinate orally.

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

Justification for classification or non-classification

Based on the above studies and predictions on Methyl nicotinate , it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Methyl nicotinate can be “Not classified” for acute oral toxicity.