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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles. However, route of administration (i.p.) is not a recommended one.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: OECD Guideline 401
Deviations:
yes
Remarks:
the substance was injected into the peritoneal cavity
Principles of method if other than guideline:
BASF-TEST: The substance was injected into the peritoneal cavity. Young adult laboratory mice were purchased from breeder. Usually the source and strain of animals were not documented. Several groups of 5 mice per sex and dose were treated simultaneously with preparations of the test substance in suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 14 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Reference substance 001
Details on test material:
- Name of test material (as cited in study report): Methoxyisopropylamin
- Physical state: liquid

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Mean body weight at study initiation:
50 mg/kg bw dose group: males: 34 g / females: 28 g
100 mg/kg bw dose group: males: 37 g / females: 29 g
200 mg/kg bw dose group: males: 35 g / females: 30 g
400 mg/kg bw dose group: males: 32 g / females: 29 g
800 mg/kg bw dose group: males: 30 g / females: 30 g
1600 mg/kg bw dose group: males: 33 g / females: 28 g

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: traganth
Details on exposure:
DOSAGE PREPARATION:
- Stock solutions prepared:
1% for the 50 mm³/kg bw dose group,
1% for the 100 mm³/kg bw dose group,
2% for the 200 mm³/kg bw dose group,
4% for the 400 mm³/kg bw dose group,
8% for the 800 mm³/kg bw dose group,
20% for the 1600 mm³/kg bw dose group

- Dose volume applied:
5 ml/kg bw of the 1% stock solution for the 50 mm³/kg bw dose group;
10 ml/kg bw of the 1% stock solution for the 100 mm³/kg bw dose group;
10 ml/kg bw of the 2% stock solution for the 200 mm³/kg bw dose group;
10 ml/kg bw of the 4% stock solution for the 400 mm³/kg bw dose group;
10 ml/kg bw of the 8% stock solution for the 800 mm³/kg bw dose group;
8 ml/kg bw of the 20% stock solution for the 1600 mm³/kg bw dose group.
Doses:
50; 100; 200; 400; 800; 1600 mm³/kg bw.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days;
- The animals were observed for mortality and clinical signs of toxicity;
- Frequency of observations: Several times on the application day, thereafter once each working day;
- Body weights were only recorded at the beginning of the study;
- Necropsy of survivors and animals which died performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 200 other: mm³/kg
Remarks on result:
other: recalculation of LD50 to mg/kg bw not possible, due to missing information on density of the suspension applied.
Clinical signs:
1600 mm³/kg bw.: Immediately after injection accelerated respiration, cavernous flanks and piloerection. Total exitus within 5 hours after application.

400-800 mm³/kg bw.: Immediately after application accelerated respiration, staggering and aggressiveness. Pain indicated by vocal response. Approx. 1.5 hours following injections in the 800 mm³/kg bw dose group lateral position, apathy, irregular intermittent respiration, cavern ous flanks, piloerection. Total exitus after 3.5 hours following application. Squatting posture and piloerection of the animals of the 400 mm³/kg bw. dose group which died on day 4 after application.

50-200 mm³/kg bw.: Immediately after application accelerated respiration, cavernous flanks, piloerection. The days following the application, the survi ving animals showed squattering posture, inactivity, irregular intermittent respiration, piloerection and apathy. After day 12 and 13, no abnormalities detected.

Body weight:
Body weights were not recorded during and at the end of the observation period.

Gross pathology:
50, 100 and 200 mm³/kg bw. dose group: some animals showed adhesions in the liver.

Decay was noted in some cases of the animals that died.

Any other information on results incl. tables

Dosis / kg
cmm
Conc.
%
Number
animals
died within
1 h
24 h
48 h
7 d
14 d
1600
20
5 m
1 / 5
5 / 5
5 / 5
5 / 5
5 / 5
5 w
0 / 5
5 / 5
5 / 5
5 / 5
5 / 5
800
8
5 m
1 / 5
5 / 5
5 / 5
5 / 5
5 / 5
5 w
0 / 5
5 / 5
5 / 5
5 / 5
5 / 5
400
4
5 m
0 / 5
5 / 5
5 / 5
5 / 5
5 / 5
5 w
0 / 5
4 / 5
4 / 5
5 / 5
5 / 5
200
2
5 m
0 / 5
1 / 5
1 / 5
2 / 5
2 / 5
5 w
0 / 5
1 / 5
1 / 5
2 / 5
2 / 5
100
1
5 m
0 / 5
0 / 5
0 / 5
1 / 5
1 / 5
5 w
0 / 5
0 / 5
0 / 5
0 / 5
0 / 5
50
1
5 m
0 / 5
0 / 5
0 / 5
0 / 5
0 / 5
5 w
0 / 5
0 / 5
0 / 5
0 / 5
0 / 5
Mortality of mice after oral application of methoxyisopropylamine.

Applicant's summary and conclusion