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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other information
Study period:
1978-04-20 to 1978-05-11 (first to last application)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable non-GLP study, irrelevant route of exposure
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
BASF test: intraperitoneal application to mice.
The study was performed as described for the oral test (please refer to section 7.2.1), except that the test item preparations were injected into the peritoneal cavity.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(methylamino)ethanol, compound with sulphur dioxide
EC Number:
244-169-0
EC Name:
2-(methylamino)ethanol, compound with sulphur dioxide
Cas Number:
21049-70-7
Molecular formula:
C3H9NO.xO2S
IUPAC Name:
(oxo-λ⁴-sulfanylidene)oxidane; 2-(methylamino)ethan-1-ol
Details on test material:
Please refer to the section "Confidential details on test material" below.

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: purchased from a breeder (Wiga)
- Age at study initiation: young adult
- Weight at study initiation (range of group mean values): 26-30 g (males), 24-26 g (females)
- Fasting period before study: 15-20 hours prior to the single administration
- Diet: Herilan MRH-Haltung (H. Eggersmann KG, Germany)

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Details on exposure:
VEHICLE
- Concentration in vehicle: 70, 200 mg/mL
- Amount of vehicle: 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED:
The concentrations of the dose formulations were adjusted to achieve the same dose volume, 10 mL/kg bw.
Doses:
700, 2000 mg/kg bw
No. of animals per sex per dose:
5 mice
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the frequency of observations was not reported; body weight was determined once prior to treatment, on days 2-4, day 7 and 13 (only mean values reported)
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic examination of premature decedents
Statistics:
No statistical analysis was performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 700 - < 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: significance level: 1 %
Mortality:
The mortality incidences after 14 days were:
0/10 at 700 mg/kg bw
10/10 at 2000 mg/kg bw
All deaths occurred within the first hour after the single i.p. treatment with the test item.
Clinical signs:
Dyspnoea, apathy and poor general condition were observed at both dose levels. Ruffled fur and spastic gait were seen at 700 mg/kg bw, and abnormal posture, spasms, clonic seizures and exsiccosis were noted at the high dose level of 2000 mg/kg bw only.
Body weight:
There was no test substance-related effect on mean body weights.
Gross pathology:
No macroscopic abnormalities were noted at necropsy of both survivors and premature decedents. No precipitates or residues of the dose formulation were present in the intraperitoneal cavity at gross pathological examination.

Applicant's summary and conclusion