Recyclamine R 401

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from Scifinder

Data source

Reference

Reference Type:

secondary source

Title:

Effect of dietary methylamine hydrochloride on growth and serum enzymes in rats

Author:

American Chemical Society

Year:

2017

Bibliographic source:

Scifinder, American Chemical Society, 2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

Subchronic repeated dose toxicity study was performed to determine the mutagenic nature of the test chemical

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methylammonium chloride

EC Number:

209-795-0

EC Name:

Methylammonium chloride

Cas Number:

593-51-1

Molecular formula:

CH5N.ClH

IUPAC Name:

methanaminium chloride

Details on test material:

- Name of test material: Methylamine hydrochloride- IUPAC name: Methanaminium chloride- Molecular formula: CH5NClH- Molecular weight: 67.5184 g/mol- Substance type: Organic- Physical state: No data- Purity: No data- Impurities (identity and concentrations): No data

Test animals

Species:

rat

Strain:

not specified

Details on species / strain selection:

No data

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Route of administration:

oral: unspecified

Details on route of administration:

No data

Vehicle:

not specified

Details on oral exposure:

No data

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

No data

Duration of treatment / exposure:

≤ 90 days

Frequency of treatment:

Daily

Doses / concentrations

Remarks:

1000 mg/Kg/day

No. of animals per sex per dose:

No data

Control animals:

not specified

Details on study design:

No data

Positive control:

No data

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: No data
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. No data

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:

BODY WEIGHT: No data
- Time schedule for examinations: No data

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations:

OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data

HAEMATOLOGY: No data
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. Serum levels of GOT, GPT, lactate dehydrogenase, and alkaline phosphatase were measured

URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data - Parameters checked in table [No.?] were examined. No data

NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data

OTHER: Growth rate and organ weight was measured

Sacrifice and pathology:

GROSS PATHOLOGY: Yes, the animals were observed for organ weight changes and gross lesions if any
HISTOPATHOLOGY: No data

Other examinations:

No data

Statistics:

No data

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

not specified

Body weight and weight changes:

not specified

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Immunological findings:

not specified

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Neuropathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Other effects:

not specified

Details on results:

Clinical signs and mortality :
Clinical signs: No signs of toxicity were noted
Mortality: No data

Body weight and weight gain: No data

Food consumption and compound intake: No data

Food efficiency: No data

Water consumption and compound intake: No data

Opthalmoscopic examination: No data

Haematology: No data

Clinical chemistry: Serum levels of GOT, GPT, lactate dehydrogenase, and alkaline phosphatase were not altered in the treated animals

Urinanalysis: No data

Neurobehaviour: No data

Organ weights: No changes in organ weight were noted in the treated animals

Gross pathology: No gross organ lesions were observed

Histopathology: No data

Effect levels

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: No significant alteration noted in growth rate, clinical signs, organ weight, clinical chemistry and gross pathology

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

The No Observed Adverse Effect level (NOAEL) for the test chemical is considered to be 1000 mg/Kg/day when exposed in rats for ≤90 days.

Executive summary:

Subchronic repeated dose toxicity study was performed to determine the toxic nature of the test chemical. The test chemical was dosed orally at 1000 mg/Kg/day for ≤90 days in rats. The animals were observed for changes in growth rate and clinical signs. Organ weight and gross pathological lesions were also observed. The clinical chemistry serum levels of GOT, GPT, lactate dehydrogenase, and alkaline phosphatase were observed in the treated animals. The treated animals did not show any clinical signs of toxicity and Serum levels of GOT, GPT, lactate dehydrogenase, and alkaline phosphatase were not altered in the treated animals. The animals did not show any alterations in organ weight and no gross organ lesions were noted. On the basis of results observed, No Observed Adverse Effect level (NOAEL) for the test chemical is considered to be 1000 mg/Kg/day.