Sodium 2-hydroxypropane-2-sulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Draize- Test. 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:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Pel.Freez, Inc. Arkansas, USA
- Age at study initiation: approx. 10-13 weeks
- Weight at study initiation: male (2.68 - 2.70 kg); femlae (2.78 - 3.12 kg)
- Housing: wire-bottomed steel cages
- Diet (e.g. ad libitum): ad libitum (Purina Rabbit Chow Checkers, Ralson Rurina Company, USA)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

Twenty-four hours prior to the dermal applications, the backs of the rabbits were clipped free of hair with electric clippers. The clipped area on each animal constituted about 30 percent of the total body surface area.
At the end of the 24-hour recovery period, just prior to the application of the test material; the clipped test skin site of one half of the animals was abraded (with a slightly bent tip of a hypodermic needle) by making a series of parallel, epidermal abrasions, every 2 or 3 centimeters longitudinally.
The test site was then covered by wrapping the trunk of each animal with an impervious plastic sleeve which was securely taped in place. This plastic wrap insured close contact of the epidermis and the test material. To prevent oral ingestion of the test material, each animal was fitted with a lightweight, flexible plastic collar which was worn throughout the observation period. Administered as an aqueous slurry.
At the end of the application period the plastic sheeting was taken off and all removable residual test material was washed off with warm tap water. One hour after test material removal, the test skin sites were examined for local skin reactions.

Duration of exposure:

24 hours

Doses:

3038 mg/kg

No. of animals per sex per dose:

2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations for motaliy and behavioral abnormalities; weights ere recorded on day 7 and 14
- Clinical signs including body weight
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 038 mg/kg bw

Mortality:

No mortality.

Clinical signs:

other: Diarrhea was observed in rabbit 3-F on the fifth day following dermal exposure to Acetone Sodium Bisulfite. The rabbit did not recover by the sacrifice date.

Gross pathology:

Necropsy examination revealed a pale spleen in rabbit 3-F. No other gross pathologic alterations were found, except for the local skin lesions as previously described.

Other findings:

The test material was severely irritating to the skin of the albino rabbit. Skin reactions at 24 hours were characterized by red, welldefined erythema, severe edema, subdermal hemorrhages and second degree burns. Superficial escharosis was present at the test skin sites at 7 days and mild desquamation at 14 days.

Any other information on results incl. tables

Dose Level (mg/kg)	Animal Number and Sex	Individual body weights (kg) Test Day Number:			Number dead / Number tested	Percent Dead
		0	7	14
3038	1-M*	2.68	2.46	2.78	0/4	0
	2-M	2.70	2.82	2.96
	3-F*	2.78	2.56	2.52
	4-F	3.12	3.06	3.10

*The skin at the site of application was abraded.