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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 2-[(2-aminoethyl)amino]ethanesulphonate
EC Number:
252-173-9
EC Name:
Sodium 2-[(2-aminoethyl)amino]ethanesulphonate
Cas Number:
34730-59-1
Molecular formula:
C4H12N2O3S.Na
IUPAC Name:
sodium 2-(2-aminoethylamino)ethanesulfonate
Details on test material:
- Composition of test material, percentage of components: approximately 50% active compound in water

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: 7 - 10 weeks
- Weight at study initiation: mean males 197 g, mean females 175 g
- Fasting period before study: 16 - 4
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The content of 50% active ingredient in the test substance was taken into account for dosis calculation.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
other: LD50 cut-off
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: The treatment was tolerated without mortalites, clinical signs, effects on body weights and gross pathological findings.
Mortality:
no deaths
Clinical signs:
other: none
Gross pathology:
no findings
Other findings:
none

Any other information on results incl. tables

Dose (mg/kg bw) Toxicological results  Onset and duration of signs  Onset of mortality
(1st) 2000 0 / 3/ 3 --- --- 
(2nd) 2000 0 / 3/ 3 --- --- 

Toxicological results:

number of dead animals / number of animals with signs of toxicity after treatment / number of animals treated

Applicant's summary and conclusion

Executive summary:

In an acute oral toxicity study performed according to OECD TG 423 a single oral dose of 2000 mg/kg bw was tolerated withouth mortalities, clinical signs, effects on weight gain and gross pathological findings. Thus, the LD50 was determined for the substance with > 2000 mg/kg bw.