Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 228-544-6 | CAS number: 6291-84-5
Repeated dose toxicity: oral
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:
- 1 992
- Bibliographic source:
- OTS0555335, NTRL, dated 9/4/92
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- 3-aminopropylmethylamine
- EC Number:
- 228-544-6
- EC Name:
- 3-aminopropylmethylamine
- Cas Number:
- 6291-84-5
- Molecular formula:
- C4H12N2
- IUPAC Name:
- (3-aminopropyl)(methyl)amine
- 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
Constituent 1
- 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 or test system 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:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: non-neoplastic
- organ weights and organ / body weight ratios
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
