Sodium ethylenesulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-11-30 to 1992-12-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Well documented and reliable GLP compliant guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1100 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium ethylenesulphonate

EC Number:

221-242-5

EC Name:

Sodium ethylenesulphonate

Cas Number:

3039-83-6

Molecular formula:

C2H4O3S.Na

IUPAC Name:

sodium ethylenesulphonate

Constituent 2

Reference substance name:

The used aqueous test solution contained 25.4% Sodium ethylenesulphonate (CAS no. 3039-83-6)

IUPAC Name:

The used aqueous test solution contained 25.4% Sodium ethylenesulphonate (CAS no. 3039-83-6)

Test material form:

other: liquid

Details on test material:

- Name of test material: Sodium ethylenesulphonate (Sodium vinylsulphonate)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester, Oxon, England
- Age at study initiation: (approximately seven to ten weeks of age prior to dosing) 7 - 10 weeks old
- Weight at study initiation: 200 - 243 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 49 (mean daily relative humidity value)
- Air changes (per hr): 10 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period

Administration / exposure

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

No. of animals per sex per dose:

5 male and 5 female rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Cages of rats were checked at least twice daily for any mortality. Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of 7 hours). On subsequent days animals were observed once in the morning and again at the end of the experimental day. Individual body weights were recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly body weight changes were calculated.
- Necropsy of survivors performed:
All animals were killed on Day 15 by cervical dislocation and were subjected to a macroscopic examination which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of all examined tissues was recorded.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 500 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: Dose level given in terms of pure sodium ethylene sulphonate (This dose level was reported as 2000 mg/kg bw of a 25% solution

Mortality:

There were no deaths following a single dermal application of sodium vinylsulphonate (25.4% solution) at 2000 mg/kg bw.

Clinical signs:

other: There were no signs of systemic reaction to treatment.

Gross pathology:

No macroscopic abnormalities were observed for animals killed on Day 15.

Other findings:

Sites of application of sodium ethylene sulphonate (25.4% solution) showed no irritation or other dermal changes (scores of zero for erythema and oedema were recorded for all animals).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present acute dermal toxicity study in male and female rats with the test item, containing 25.4% sodium ethylene sulphonate, the obtained acute dermal LD50 value was greater than 2000 mg/kg bw for the tested solution. Based on this study the derived LD50 for 100% sodium ethylene sulphonate was greater than 500 mg/kg bw.