Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979-06-20 until 1979-07-24
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP, no guideline was followed/ mentioned (but similar to OECD 401 guideline)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N-bis(3-aminopropyl)methylamine
EC Number:
203-336-8
EC Name:
N,N-bis(3-aminopropyl)methylamine
Cas Number:
105-83-9
Molecular formula:
C7H19N3
IUPAC Name:
bis(3-aminopropyl)(methyl)amine

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: By males an average weight of 262.5 g, by females an average weight of 207.5 g
- Fasting period before study: 15 h - 20 h before administration
- Diet: Herilan MRH-Haltung ; H. Eggersmann KG

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10.0, 6.81, 4.64, 3.16 % (w/v)
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:
1000, 681, 464, 316 mg/kg
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: For mortality -1hour, 1, 2, 7, 14 days, for weighing 2 - 4 days, 7, 13 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
Chi - 2 test

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
691 mg/kg bw
Based on:
test mat.
Mortality:
At the dose group of 316 mg/kg bw 0 % mortality after 14 days of observation
At the dose group of 464 mg/kg bw 10 % mortality after 14 days of observation
At the dose group of 681 mg/kg bw 60.0 % mortality after 14 days of observation
At the dose group of 1000 mg/kg bw 80 % mortalityafter 14 days of observation.
Clinical signs:
other: At dose groups 464, 691 and 1000 mg/kg bw animals were in poor general state and the following signs and symptoms were observed: dyspnea, apathy, staggering, spastic gait, piloerection, erythema and salivation.
Gross pathology:
Necropsy findings by animals that died:
Heart: acute dilatation ; acute passive hyperemia
Liver: peripheral clay-colored acinar pattern
Intestines : atonic and diarrheal contents
Kidneys : pale in several animals

Necropsy findings by sacrificed animals:
No abnormalities were detected.

Applicant's summary and conclusion