Sodium ethylenesulphonate

Endpoint summary

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

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 or test system 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:

other: 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.

Gross pathology:

No abnormalities were observed.

Interpretation of results:

GHS criteria not met

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

Value:

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:

guideline study

Remarks:

Well documented and reliable GLP compliant guideline study

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

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

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.

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).

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

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 ethylene sulphonate 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 ethylene sulphonate, the obtained acute oral LD50 value was greater than 15000 mg/kg bw. Based on this study the derived LD50 for 100% sodium ethylene sulphonate 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 ethylene sulphonate via inhalation is unlikely, due to the negligible vapour pressure of the substance. 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 ethylene sulphonate 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 body weight gains were recorded for two females on Day 8 and for two males on Day 15; a small body weight loss was recorded for one female on Day 8. All other rats achieved anticipated body weight 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 ethylene sulphonate, the obtained acute dermal LD50 value was greater than 2000 mg/kg bw. The derived LD50 for 100 % sodium ethylene sulphonate was greater than 500 mg/kg bw.

The used dose level of 100 % sodium ethylene sulphonate in the present acute dermal toxicity study is lower than recommended 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 ethylene sulphonate is more toxic by dermal exposure. Thus, the dermal LD50 of 100 % sodium ethylene sulphonate can reasonably be expected to exceed 2000 mg/kg bw. Against this background, the conduction of an additional acute dermal toxicity study at the limit dose level of 2000 mg/kg bw with 100 % sodium ethylene sulphonate 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 ethylene sulphonate 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).