Sodium 2-hydroxypropane-2-sulphonate

Endpoint summary

Description of key information

LD50 (oral, rat): >2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

guideline study

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

oral:

A 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 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. The LD50 of the test substance after oral administration was found to be greater than 2000 mg/kg body weight for male and female rats.

Justification for classification or non-classification

Based on the results, the test item is no subject to classification and labelling according to Regulation (EC) No 1272/2008 (CLP).