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EC number: 252-173-9 | CAS number: 34730-59-1
Acute Toxicity: oral
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:
- 1 997
- 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
- 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
Constituent 1
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.
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