Disodium 3,3'-dithiobis[propanesulphonate]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 June - 22 June 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

(The Department of Health of the Government of the United Kingdom)

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 3,3'-dithiobis[propanesulphonate]

EC Number:

248-324-3

EC Name:

Disodium 3,3'-dithiobis[propanesulphonate]

Cas Number:

27206-35-5

Molecular formula:

C6H14O6S4.2Na

IUPAC Name:

disodium 3,3'-disulfanediyldipropane-1-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): SPS
- Physical state: white powder
- Analytical purity: no data
- Lot/batch No.: 1060020/051
- Expiration date of the lot/batch:
- Storage condition of test material: ambient temperature (<25°C) , stored under artificial light

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd. , Moston , Sandbach , Chesire , UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.62 - 3.05 kg
- Housing: animals were individually housed in suspended metal cages
- Diet (e.g. ad libitum): STANRAB SQC Rabbit Diet (Special Diets Services Ltd. , Witham , Essex , UK)
- Water (e.g. ad libitum): mains drinking water , ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 20
- Humidity (%): 60 - 62
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

(the substance was moistened with 0.5 ml distilled water)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): the substance was moistened with 0.5 ml distilled water

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: the test site was covered with a 2.05 x 2.5 cm cotton gauze patch that was held in place with a strip of surgical adhesive tape (BLENDERM : approximate size 2.5 cm x 4.0 cm) . The trunk of the rabbits was then wrapped in an elasticated corset (TUBIGRIP) .

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test material was removed by gentle swabbing with cotton wool soaked in distilled water .
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system . The test sites were examined 1 , 24 , 48 and 72 hours after the exposure ended .

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Very slightly erythema was noted at all treated skin sites one hour after patch removal . All treated skin sites appeared normal at the 24-hour observation .

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The study was performed according to the OECD TG404 without deviations and therefore considered to be of the highest quality (reliability Klimisch 1). The validity criteria of the test system are fulfilled. The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992) and Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema. All treatment sites appeared normal at the 24-hour observation. The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.