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Toxicological information

Acute Toxicity: dermal

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
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

Constituent 1
Chemical structure
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.