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Administrative data

Description of key information

Oral: LD50 > 3750 mg/kg bw  for the rat 
Inhalation: no study required
Dermal: LD50 > 500 mg/kg bw for the rat

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
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
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
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
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.
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
3 750 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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
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
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
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.
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).
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
500 mg/kg bw

Additional information

Acute oral toxicity

 

In an acute oral toxicity study (Hoechst AG (a), 1976) female Wistar rats (10 rats per dose) were treated with a solution containing 25 % Sodium ethylenesulphonate at a dose level of 15000 mg/kg bw. No mortality was observed. 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. In one animal body weight gain was slightly decreased after the 14 day observation period. All other animals showed normal body weight gain. No abnormalities were observed at macroscopic examination. 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.

 

Acute inhalation toxicity

In accordance with column 2, Annex VIII, section 8.5 of Regulation (EC) No 1907/2006 (REACH), no study has to be conducted if information is provided for two relevant routes of exposure. Acute toxicity studies are available for the oral and the dermal exposure routes and the exposure of humans to Sodium etyhlenesulphonate via inhalation is unlikely. Thus, no acute inhalation toxicity study has to be conducted.

Acute dermal toxicity

 

An acute dermal toxicity study (Huntingdon Research Centre Ltd. (b), 1993) was performed with a test solution containing 25.4 % Sodium ethylenesulphonate in Sprague-Dawley rats, in compliance with GLP, OECD Guideline No. 402 and OPPTS 798.1100. A limit test was carried out. A single group of male and female animals (n=5 animals/sex) was dermally exposed to 2000 mg/kg bw. The test solution covered 10 % of the total body surface and was left in contact with the skin for 24 hours, followed by a 14-day observation period. No mortality occurred during the study. Neither male nor female animals treated at 2000 mg/kg bw showed behavioural changes and no systemic toxic signs were noted during the study. 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. No macroscopic abnormalities were observed for animals killed on Day 15. The application sites showed no signs of irritation or other dermal changes (scores of zero for erythema and oedema were recorded for all animals). 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. The derived LD50 for 100 % Sodium ethylenesulphonate was greated than 500 mg/kg bw.

The used dose level of 100 % Sodium ethylenesulphonate in the present acute dermal toxicity study is lower than recommendend in the guideline (max. tested dose 500 mg/kg bw instead of 2000 mg/kg bw). However, as specified in chapter 7.1 toxicokinetik, metabolism and distribution the dermal absorption rate (25 %) is considerably lower than the oral absorption rate (50 %). Based on this it is not expected that 100 % Sodium ethylenesulphonate is more toxic by dermal exposure. Thus, the dermal LD50 of 100 % Sodium ethylenesulphonate can reasonably be expected to exceed 2000 mg/kg bw. Against this backround, the conduction of an additional acute dermal toxicity study at the limit dose level of 2000 mg/kg bw with 100 % Sodium ethylenesulphonate is neither scientifically nor ethically justified.


Justification for selection of acute toxicity – oral endpoint
Most reliable study

Justification for selection of acute toxicity – dermal endpoint
Most reliable study

Justification for classification or non-classification

Based on the results obtained, Sodium ethylenesulphonate was not classified and labelled for acute toxicity according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP). The test substance dose not meet the criteria for specific target organ toxicity after single exposure (STOT SE) according to Regulation (EC) No 1272/2008 (CLP).