Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is in accordance to common test guidelines and GLP and therefore rated as reliable without restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 2-hydroxyethanesulphonate
EC Number:
216-343-6
EC Name:
Sodium 2-hydroxyethanesulphonate
Cas Number:
1562-00-1
Molecular formula:
C2H6O4S.Na
IUPAC Name:
sodium 2-hydroxyethane-1-sulfonate
Details on test material:
- Name of test material (as cited in study report): Ethansalz 97/100
- Molecular formula: C2H5O4SNa
- Analytical purity: > =97 % (wt/wt)
- impurities: in small amounts HOCH2CH2-O-CH2CH2SO3Na
- batch no. Op. 36
- production date: 21.05.1986
- physical state: white powder
- Storage condition of test material: darkness at approximately 22°C

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG Kastengrund - SPF breed
- Weight at study initiation: 178-181 g (male), 167-174 g (female)
- Age at study initiation: ca. 7 weeks (male), ca. 8 weeks (female)
- Fasting period before study: ca. 16 hours before and 3-4 hours after application
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum
- Water: Tap water ad libitum
- Acclimatization period: > 5 days

ENVIRONMENTAL CONDITIONS
- Housing: in fully air-conditioned rooms in Macrolon cages
- Temperature: 22 ± 3°C
- Humidity: 50 ± 20 %
- Photoperiod (hrs light): 12 per day

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
- concentration in vehicle: 50 % (w/v)
- application volume 10 ml/kg bw
Doses:
The acute oral toxicity was tested only at a dose level of 5000 mg/kg body weight.
No. of animals per sex per dose:
5 male and 5 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations once daily / Weighing once weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Sex: male, Dose: 5000 mg/kg bw, Mortality rate: 0 / 5
Sex: female, Dose: 5000 mg/kg bw, Mortality rate: 1 / 5
Clinical signs:
- no symptoms of poisoning
Body weight:
- reduced body weight gain in one female rat
Gross pathology:
Dissection of rats killed at the end of the observation period revealed no macroscopic findings.
Necropsy revealed no apparent signs of toxicity in the deceased animal and it did not appear to be treatment related.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of Sodium 2-hydroxyethanesulphonate (LD50) was > 5000 mg per kg body weight. Based on the result of this study Sodium 2-hydroxyethanesulphonate is not subject for labelling and classification requirements according to regulatory requirements.
Executive summary:

Acute toxicity after single oral application was tested in male and female rats, which received 5000 mg/kg bw. One female and no male died. The necropsy of the deceased female did not reveal any effect and the death was not supposed to be treatment-related. The LD50 value for acute oral toxicity is >5000 mg/kg bw.