Sodium 2-bromoethanesulphonate

Endpoint summary

Description of key information

In an acute toxicity study in rats according to OECD Guideline 423, an LD50 of above 2000 mg/kg bw was determined (UN GHS: No Category) (reference 7.2.1-1).

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

Study period:

05 September 2017 - 07 November 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2002-02-08

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI (Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 9 weeks
- Weight at study initiation: 157 - 184 g
- Fasting period before study: 17 to 20 hours before start of treatment until 4 hours after administration.
- Housing:
During the acclimation phase, the three rats per treatment group were group-housed in type IV Makrolon® cages.
One day before treatment, the rats were single-housed in type III Makrolon® cages.
- Diet: maintenance diet (V1534, ssniff Spezialdiäten GmbH, Germany), ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.8 - 23.2
- Humidity (%): 43.9 - 63.5

Route of administration:

oral: gavage

Vehicle:

other: 0.25% aqueous hydroxypropylcellulose

Details on oral exposure:

VEHICLE
- Amount of vehicle: 10 m/kg bw
- Justification for choice of vehicle: well tolerated and established standard vehicle

DOSAGE PREPARATION: The test item preparation was made directly before administration. Appropriate amounts of the test item were suspended in the vehicle using a spatula, a mini shaker (Vortex Genie 2®, Scientific Industries Inc, New York, USA), Ultra-Turrax device (Ultra-Turrax T25, IKA®-Werke GmbH & Co. KG, Staufen, Germany) and a magnetic stirrer. The test item preparation was administered within less than 1 hour after preparation.

CLASS METHOD
- Rationale for the selection of the starting dose: Due to the fact, that information concerning the toxic potential of methyl methanesulfonate (Sax, N.I.; 1984) is available, the study with Sodium 2-bromoethanesulfonate was started in 3 females with 300 mg/kg body weight.

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On the day of treatment, each animal was observed for mortality and for symptoms of intoxication at scheduled intervals according to the record sheets. On the following days, the rats were examined once daily. Symptoms were recorded individually for each animal. All animals were weighed before treatment (day 1) and on day 2, 4, 6, 8, 11, 13 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

The mean initial body weight was calculated with a pocket calculator.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs of toxicity were observed.

Gross pathology:

No organ alterations were identified during the gross pathological examination.

Table 1: Body weight development

Animal No.	Sex	Dose [mg/kg]	Body weight in g on day								Body weight gain in g
			1	2	4	6	8	11	13	15	Day 1 to 15
1	Female	300	161	181	184	186	189	190	196	197	+36
2	Female	300	157	175	176	180	181	188	186	192	+35
3	Female	300	184	205	209	220	218	220	226	227	+43
4	Female	300	169	178	188	184	190	194	196	200	+31
5	Female	300	170	182	181	188	185	194	194	196	+26
6	Female	300	162	173	177	181	187	187	193	196	+34
7	Female	2000	157	180	188	186	195	196	200	202	+45
8	Female	2000	150	159	165	163	169	168	172	175	+25
9	Female	2000	163	178	192	197	204	205	206	216	+53
10	Female	2000	164	181	188	195	196	200	209	210	+46
11	Female	2000	174	193	194	197	202	209	208	214	+40
12	Female	2000	165	183	185	187	193	196	197	206	+41

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute toxicity study in rats according to OECD Guideline 423, an LD50 of above 2000 mg/kg bw was determined.

Executive summary:

In an acute toxicity study in female Wistar rats according to OECD Guideline 423, the potential acute toxic effect of the test item was determined. The study was started with 300 mg/kg bw in 3 female rats, continued with further 3 females treated with 300 mg/kg. Due to the fact, that no mortality was seen after treatment with 300 mg/kg, further 6 females were treated with 2000 mg/kg.

Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy. No mortality occurred during the course of this study. No clinical signs of toxicity were observed. The body weight development was inconspicuous throughout the study. The gross pathological examination revealed no organ alterations. The test item had no acute toxic potential under the conditions of the present study, and the LD50 value was determined to be higher than 2000 mg/kg after single oral administration in female rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Guideline conform study; Klimisch code 1

Additional information

In an acute toxicity study in female Wistar rats according to OECD Guideline 423 (reference 7.2.1-1), the potential acute toxic effect of the test item was determined. The study was started with 300 mg/kg bw in 3 female rats, continued with further 3 females treated with 300 mg/kg. Due to the fact, that no mortality was seen after treatment with 300 mg/kg, further 6 females were treated with 2000 mg/kg. Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy. No mortality occurred during the course of this study. No clinical signs of toxicity were observed. The body weight development was inconspicuous throughout the study. The gross pathological examination revealed no organ alterations. The test item had no acute toxic potential under the conditions of the present study, and the LD50 value was determined to be higher than 2000 mg/kg after single oral administration in female rat (UN GHS: No Category).

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.

As a result the test item is not considered to be classified for acute toxicity (UN GHS: No Category) under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.