Registration Dossier

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:
other: 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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EPA OTS 798.1100 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10% of the total body surface
- Type of wrap if used: gauze which was held in place with a non-irritative dressing encircled firmly around the trunk

REMOVAL OF TEST SUBSTANCE
- Washing: Yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 2000 mg/kg bw

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw (i.e. 69 mL/kg with a specific gravity of 1.183) of a 25.4% solution
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 mortalities. 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 bodyweights were recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight 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:
There were no signs of systemic reaction to treatment.
Body weight:
Slightly low bodyweight gains were recorded for two females on Day 8 and for two males on Day 15; a small bodyweight loss was recorded for one female on Day 8. All other rats achieved anticipated bodyweight gains throughout the study.
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

Conclusions:
Under the conditions of the present acute dermal toxicity study in male and female rats with the test item, containing 25.4% Sodium ethylenesulphonate, 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 ethylenesulphonate was greated than 500 mg/kg bw.