Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
BASF-Test:
Young adult laboratory mice were purchased from breeder. Several groups of 5 mice per sex and dose are treated simultaneously with preparations of the test substance in a suitable vehicle. The substance is injected into the peritoneal cavity. The concentrations of the preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs is performed during the study period of 7 days.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N-dimethylisopropylamine
EC Number:
213-635-5
EC Name:
N,N-dimethylisopropylamine
Cas Number:
996-35-0
Molecular formula:
C5H13N
IUPAC Name:
N,N-dimethylpropan-2-amine
Details on test material:
- Name of test material (as cited in study report): N, N-Dimethylisopropylamin
- Purity: 99%

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ivanovas
- Mean weight at study initiation: 23.9 g (females), 27.7 g (males)
no further data available

ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Doses:
100, 147, 215, 316, 464 and 681 µL/kg bw (=> 72, 106, 155, 228, 334 and 490 mg/kg bw, based on a density of 0.72 g/cm³)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 8 days
- Frequency of observations and weighing: animals were observed for mortality and clinical signs 1, 24 and 48 h and 8 days after application; weighing was done at study initiation and on day 2 and 8 (surviving animals)
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 100 mg/kg bw
Based on:
test mat.
95% CL:
> 72 - < 106
Mortality:
- 72 mg/kg bw: 1/10 (1 animal died within 48 h)
- 106 mg/kg bw: 6/10 (1 animal died within 48 h and 5 within the first week)
- 155 mg/kg bw: 10/10 (4 animals died within 24 h, 2 within the second day and 4 within the first week after application)
- 334 and 228 mg/kg bw: 20/20 (all animals died within 24 h after application)
- 490 mg/kg bw: 10/10 (7 animals died within the first hour after application, 3 within 24 h)
Clinical signs:
Dyspnoea, apathy, tremor, poor general state, spastical gait, abdominal position, convulsions

Applicant's summary and conclusion