Sodium 2-hydroxypropane-2-sulphonate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Remarks:

A routine inspection by FDA at Industrial Bio-Test laboratories (IBT) in 1976 uncovered numerous discrepancies between raw data and study reports, and gross deficiencies in study conduct; mainly in non-acute studies, but also in acute toxicity studies. Thus, study reports from IBT between the 1960´s and until 1978 should be taken with care. An important consideration is the consistency of the findings from the IBT study with findings from other studies that were conducted at reputable test houses at a later date to the IBT study (to rule out the possibility of data being manipulated by IBT to be consistent with existing data). REFERENCE: OECD (2005): Manual for investigation of HPV Chemicals, Chapter 3: Data Evaluation (3.1 Guidance for Determining the Quality of Data fo the SIDS Dossiers: Reliability, relevance and adequacy, 3.1.8 Acceptance and use of studies from Industrial Bio-Test laboratories. OECD - Manual for the Assessment of Chemicals (http://www.oecd.org/chemicalsafety/risk-assessment/chapter3dataevaluation.htm)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

Purity of the test material was not listed.

GLP compliance:

not specified

Test type:

other:

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

Test material form:

solid

Details on test material:

white powder

Test animals

Species:

rat

Strain:

other: Albino rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Rats
- Age at study initiation: young adult
- Housing: stock cages
- Diet (e.g. ad libitum): standard laboratory diet (Wayne LAB-BLOX for Rats, Chicago, USA)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

clean air

Details on inhalation exposure:

The dust was suspended by passing clean, dry air (-40° C dewpoint) through a dust shaker rnechanisrn. The resulting air-dust rnixture was then introduced into the exposure charnber. Each animal was caged separately during exposure to minimize filtration of inspired air by animal fur. The average analytical concentration of airborne dust was obtained by repeated air sampling.

Duration of exposure:

4 h

Concentrations:

1530 mg/m³ air (maximum attainable concentraion under the conditons stated,)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to inhaltion exposur and at the end of the observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1 530 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

There were no deaths during exposure or the 14-day observation period which followed.

Clinical signs:

other: Red nasal discharge was observed in 1 test animal after 180 minutes of exposure. This reaction lasted >8<18 hrs.

Body weight:

The average 2-week body weight gains were within the normal limits.

Gross pathology:

Complete nec ropsies were done on all male and female rats us ed in this experiment when the study was terminated at the end of the 14-day post-exposure observation period. No gross tissue changes attributable to the effects of the test material were observed in any of the rats examined.

Any other information on results incl. tables

 

Group No.	Total Number of Animals Male/Female	Analytical Concentration (mg/m³ air)	Mortality Male - Female	Weight Gain Male -female (grams)
Test	5/5	1530*	0/5 – 0/5	81 - 31

*Maximum attainable concentration under the conditions stated.