Sodium 2-hydroxyethanesulphonate

Acute Toxicity: oral

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

Test material information

Constituent 1

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 1,4-bis[(2-ethylhexyl)oxy]-1,4-dioxobutane-2-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:

other: - no symptoms of poisoning

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:

GHS criteria not met

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.