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Description of key information

LD50 was observed at the dose level of 1600 mg/kg bw in range of1600 to 3200 mg/kg.

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data from peer reveiw publication
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To evaluate the acute toxicity of Methylamine hydrochloride in rats.
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Methylamine hydrochloride (methanaminium chloride)
- Molecular formula (if other than submission substance): CH5N.Cl H
- Molecular weight (if other than submission substance): 67.5184 g/mole
- Substance type: Organic
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data available.
Doses:
1600 to 3200 mg/kg
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:
1 600 mg/kg bw
Based on:
test mat.
95% CL:
1 600 - 3 200
Remarks on result:
other: 50 % mortality observed
Mortality:
50 % mortality was observed.
Clinical signs:
other: No data available.
Gross pathology:
No data available.
Other findings:
No data available.
Interpretation of results:
Toxicity Category IV
Conclusions:
LD50 was considered to be 1600 mg/kg for Methylamine hydrochloride in rats by oral administration.
Executive summary:

In a acute oral toxicity study, rats were treated with methanaminium chloride orally. The LD50 was observed at the dose level of 1600 mg/kg bw in the range of 1600 to 3200 mg/kg.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 600 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

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity:

In different studies, Methanaminium chloride 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 rats for Methanaminium chloride along with the study available on structurally similar read across substance Methylamine (CAS: 74-89-5). The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.

In a study by Kinney et al (Inhalation Toxicology, 2:29-39, 1990), rats were administered methanaminium chloride orally to gauge the acute oral toxicity. The LD50 was observed at the dose level of 1600 mg/kg bw in range of1600 to 3200 mg/kg.

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 methanaminium chloride. The LD50 was estimated to be 1296 mg/kg bw when Sprague-Dawley male and female rats were orally exposed with 4- methanaminium chloride.

Also it is further supported experimental data by MAK Collection (MAK Value Documentation, 146–153, 2012) on structurally similar read across substance Methylamine (CAS: 74-89-5), rats were treated with Methylamine orally as 40 % solution. LD50 was considered to be 698 mg/kg bw (547 – 1007 mg/kg) when rat were treated with Methylamine orally.

Thus, based on the above predictions and study on Methanaminium chloride and its read across substances and by conceding the weight of evidence, it can be concluded that LD50 value is less than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Methanaminium chloride can be classified as “Category IV” of acute oral toxicity. 

Justification for classification or non-classification

Based on the above predictions and study on Methanaminium chloride and its read across substances and by conceding the weight of evidence, it can be concluded that LD50 value is less than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Methanaminium chloride can be classified as “Category IV” of acute oral toxicity.