Sodium 2-hydroxypropane-2-sulphonate

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 2-hydroxypropane-2-sulphonate

EC Number:

208-761-2

EC Name:

Sodium 2-hydroxypropane-2-sulphonate

Cas Number:

540-92-1

Molecular formula:

C3H8O4S.Na

IUPAC Name:

sodium 2-hydroxypropane-2-sulphonate

Details on test material:

- Name of test substance : Natrium-2-hydroxypropan-2-sulfonat
- CAS No.: 540-92-1
- Batch No.: 13./14.01.2001
- Date of production: Jan. 13./14.200 1
- Degree of purity/Composition: 13 g/ 100 g (elemental analysis); 87.2 g / 100 g water (Karl-Fischer titration)
- Physical state/appearance: Liquid/colorless, clear
- Homogeneity: The test substance was homogeneous.
- Storage conditions : Room temperature, covered with N2
- Stability: The analytical characterization was run in parallel to the administration phase of the study. Therefore the results of this analysis represent the composition of the test substance and no reanalysis is necessary. According to the sponsor the stability of the test substance was given until Feb. 10, 2001

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: Young adult animals (male animals approx. 8 - 12 weeks, female animals approx. 14 - 18 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight); males, mean: 229 g; females, mean: 215 g
- Fasting period before study: at least 16 hours before administration
- Housing: single housing in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Remarks:

Aqueous solution as supplied

Details on oral exposure:

DOSE VOLUME APPLIED: 15.4 ml/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays. Individual body weights were determined shortly before administration (day 0), weekly thereafter and at the end of the study (before fasting period). Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Signs of toxicity comprised impaired and poor general state, dyspnoea, apathy, staggering and piloerection and were observed until including hour 5 after administration.

Gross pathology:

No macroscopic pathologic abnormalities were noted.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 2000 mg/kg body weight for male and female rats.

Executive summary:

The study was performed to assess the acute toxicity following oral administration of Natrium-2-hydroxypropan-2-sulfonat in Wistar rats. Single doses of 2000 mg/kg body weight of the test substance in form of the aqueous solution supplied by the sponsor were given to two dose groups of three fasted animals, each (males and females) by gavage. No mortality occurred in the dose groups. Clinical signs and findings in the dose groups comprised impaired and poor general state, dyspnoea, apathy, staggering and piloerection. Findings were observed until including study hour 5 after administration. The mean body weights of the dose groups increased throughout the study period. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the observation period. Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 2000 mg/kg body weight for male and female rats.