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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable non-GLP study, comparable to guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Principles of method if other than guideline:
BASF test. The study was conducted before the OECD guideline 401 was first adopted.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Reaction mass of bis(2-hydroxyethanaminium) sulfite and 2-(methylamino)ethanol - oxosulfane oxide (1:1)
IUPAC Name:
Reaction mass of bis(2-hydroxyethanaminium) sulfite and 2-(methylamino)ethanol - oxosulfane oxide (1:1)
Details on test material:
- Name of test material: Kauramin-Härter CE 5196 flüssig; N-Methyläthanolammonium(-hydrogen) sulfit + Äthanolammonium(-hydrogen) sulfit in Wasser (German)
- Physical state: liquid
- Composition of test material, percentage of components: N-Methylethanolamine: 21 %, Ethanolamine: 24.6 %, Sulfur dioxide: 35 %, Water: 19.4 %
- Other: pH-neutral mixture

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: purchased from a breeder (Hagemann)
- Age at study initiation: young adult
- Weight at study initiation (range of group mean values): 170-280 g (males), 160-220 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:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 215, 261, 316, 383, 500 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:
2150, 2610, 3160, 3830, 5000 mg/kg bw
No. of animals per sex per dose:
5 rats
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 days 12-13 (only mean values reported)
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic examination of premature decedents
Statistics:
Probit analysis according to Finney (1971)
Reference:
Finney DJ (1971). Probit Analysis. Cabridge University Press, 3rd edition.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 562 mg/kg bw
Based on:
test mat.
95% CL:
3 231 - 3 994
Remarks on result:
other: slope factor: 1.20
Mortality:
The mortality incidences after 14 days were:
0/10 at 2150 mg/kg bw
1/10 at 2610 mg/kg bw
2/10 at 3160 mg/kg bw
6/10 at 3830 mg/kg bw
10/10 at 5000 mg/kg bw
Clinical signs:
other: No clinical signs were noted at 2150 mg/kg bw. Dyspnoea, apathy, stagger, spastic gait, ruffled fur and poor general condition were noted at 2610 mg/kg bw and above. Further clinical signs oberved were abnormal posture and paresis at 3160 mg/kg bw, marked
Gross pathology:
There were no macroscopic abnormalities noted at scheduled necropsy.
Premature decedents showed acute right heart dilatation, acute congestive hyperaemia, diffusely reddened glandular stomach (epithelium) and atony as well as diarrhoeic content of the intestine.

Applicant's summary and conclusion