Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically fully valid study, but predating the implementation fo OECD Guidelines and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Similar to a OECD 401 limit test (3750 mg/kg bw sodium ethylenesulphonate were tested on 10 rats).
GLP compliance:
no
Remarks:
Study performed prior to implementation of GLP
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) (25% solution)

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 95-109 g
- Fasting period before study: yes (the animals were not feeded 16 hours before treatment)
- Diet: ad libitum
- Water: ad libitum
- Housing: animals were housed in plastic cages filled with horn shavings

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
no data
Doses:
15000 mg/kg bw (test solution) of a 25% Sodium ethylenesulphonate solution
No. of animals per sex per dose:
10 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopical examination
Statistics:
not performed

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 3 750 mg/kg bw
Based on:
act. ingr.
Remarks:
sodium ethylenesulphonate (CAS no. 3039-83-6)
Remarks on result:
other: Dose level given in terms of pure Sodium ethylenesulphonate (This dose level was reported as 15000 mg/kg bw of a 25% solution).
Mortality:
No mortality was observed
Clinical signs:
Semi prone position and lustreless coat were noted shortly after the single oral gavage administration. No clinical signs were observed during the remainder of the 14-day observation period.
Body weight:
In one animal body weight gain was slightly decreased after the 14 day observation period. All other animals showed normal body weight gain.
Gross pathology:
No abnormalities were observed.

Applicant's summary and conclusion

Conclusions:
Under the conditions of the present acute oral toxicity study in female rats with the test solution, containing 25% Sodium ethylenesulphonate, the obtained acute oral LD50 value was greater than 15000 mg/kg bw. Based on this study the derived LD50 for 100% Sodium ethylenesulphonate is greater than 3750 mg/kg bw.