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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from NTRL

Data source

Reference
Reference Type:
secondary source
Title:
Initial submission: Letter from Eastman Kodak Co to USEPA Regarding Basictoxicity of 3-methylaminopropylamine with Attachments and Cover Letter dated 9/4/92.
Author:
NTRL
Year:
1992
Bibliographic source:
OTS0555335, NTRL, dated 9/4/92

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mention below
Principles of method if other than guideline:
To evaluate the toxic potential of 3-methylaminopropylamine in rats by oral gavage for 16 days.
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material : (3-aminopropyl)(methyl)amine; 3-Amino-1-methylaminopropane
- Molecular formula : C4H12N2
- Molecular weight : 88.1528 g/mol
- Smiles notation : N(CCCN)C
- InChl : 1S/C4H12N2/c1-6-4-2-3-5/h6H,2-5H2,1H3
- Substance type: Organic
- Physical state: Liquid
Specific details on test material used for the study:
- Name of test material : (3-aminopropyl)(methyl)amine; 3-Amino-1-methylaminopropane
- Molecular formula : C4H12N2
- Molecular weight : 88.1528 g/mol
- Smiles notation : N(CCCN)C
- InChl : 1S/C4H12N2/c1-6-4-2-3-5/h6H,2-5H2,1H3
- Substance type: Organic
- Physical state: Liquid

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Not specified.

Administration / exposure

Route of administration:
oral: gavage
Details on route of administration:
Not specified.
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 and 50 mg/kg/day
Duration of treatment / exposure:
16 days
Frequency of treatment:
12 exposure
Doses / concentrationsopen allclose all
Dose / conc.:
0 other: mg/kg bw/day
Dose / conc.:
10 other: mg/kg bw/day
Dose / conc.:
50 other: mg/kg bw/day
No. of animals per sex per dose:
Total no 15
0 mg/kg/day bw;5 rats
10 mg/kg/day bw;5 rats
50mg/kg/day bw;5 rats
Control animals:
yes, concurrent vehicle
Details on study design:
Not specified.

Examinations

Observations and examinations performed and frequency:
Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: Yes

DETAILED CLINICAL OBSERVATIONS: Yes

Mortality: not specified

BODY WEIGHT: Yes


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: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available.

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 available

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available

OPHTHALMOSCOPIC EXAMINATION: No data available

HAEMATOLOGY: Yes
- Parameters checked in table [No.?] were examined.- Haemoglobin , haematocrits and White blood cell
Counts (neutrophil and monocyte) were observed.

CLINICAL CHEMISTRY: Yes
- Parameters checked in table [No.?] were examined. - Glutamic oxaloacetic transaminase, lactic dehydrogenase, urea nitrogen, alkaline phosphatase, glucose and glutamic pyruvic transaminase were observed.

URINALYSIS: No data available.

NEUROBEHAVIOURAL EXAMINATION: No data available.

Other; Absolute and relative liver and kidney weight were observed.
Sacrifice and pathology:
Sacrifice and pathology
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Statistics:
Yes,Mean± Standard deviation was observed.

Results and discussion

Results of examinations

Clinical signs:
effects observed, non-treatment-related
Description (incidence and severity):
No statically significant effects were observed at dose level of 10 and 50 mg/kg bw/day in treated group compare to control.
Mortality:
not specified
Body weight and weight changes:
effects observed, non-treatment-related
Description (incidence and severity):
As though there was slight decrease in the body weight but no statically significant effects were observed at dose level of 10 and 50 mg/kg bw/day in treated group compare to control.
Food consumption and compound intake (if feeding study):
effects observed, non-treatment-related
Description (incidence and severity):
As though there was slight decrease in the food intake but no statically significant effects were observed at dose level of 10 and 50 mg/kg bw/day in treated group compare to control.
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
effects observed, non-treatment-related
Description (incidence and severity):
No statically significant effects were observed at dose level of 10 and 50 mg/kg bw/day in treated group compare to control.
Clinical biochemistry findings:
effects observed, non-treatment-related
Description (incidence and severity):
No statically significant effects were observed at dose level of 10 and 50 mg/kg bw/day in treated group compare to control.
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
effects observed, non-treatment-related
Description (incidence and severity):
No statically significant effects were observed at dose level of 10 and 50 mg/kg bw/day in treated group compare to control.
Gross pathological findings:
effects observed, non-treatment-related
Description (incidence and severity):
No statically significant effects were observed at dose level of 10 and 50 mg/kg bw/day in treated group compare to control.
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
effects observed, non-treatment-related
Description (incidence and severity):
No statically significant effects were observed at dose level of 10 and 50 mg/kg bw/day in treated group compare to control.
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Effect levels

Dose descriptor:
NOAEL
Effect level:
50 other: mg/kg/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
body weight and weight gain
food consumption and compound intake
haematology
clinical biochemistry
organ weights and organ / body weight ratios
gross pathology
histopathology: non-neoplastic
Remarks on result:
other: No significant effects were observed on the clinical sign, food intake, body weight, Haematology, clinical chemistry, gross pathology and histopathology.

Target system / organ toxicity

Critical effects observed:
not specified
Treatment related:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified

Any other information on results incl. tables

Organ weight

Dose

50 mg/kg/day

Organ

liver

kidney

Absolute

N

N

Relative

N

N

Dose

10 mg/kg/day

Absolute

N

N

Relative

N

N

Applicant's summary and conclusion

Conclusions:
NOAEL was considered to be 50 mg/kg/day for 3-methylaminopropylamine in rats by oral gavage for 16 days study.
Executive summary:

In a Repeated dose study for 3-methylaminopropylamine in rats by oral gavage. The animals were exposed to 12 dosage daily at the concentration of 0,10 and 50 mg/kg bw/day for 16 days. As no statically significant effects were observed on the clinical sign, food intake, body weight, Haematology, clinical chemistry, gross pathology and histopathology of the treated male and female rats compare to control. Therefore NOAEL was considered to be 50 mg/kg/day for3-methylaminopropylamine in rats by oral gavage for 16 days study.