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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 2-bromoethanesulphonate
EC Number:
224-244-4
EC Name:
Sodium 2-bromoethanesulphonate
Cas Number:
4263-52-9
Molecular formula:
C2H5BrO3S.Na
IUPAC Name:
sodium 2-bromoethanesulphonate
Test material form:
solid

Test animals

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

Administration / exposure

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.

Results and discussion

Effect levels
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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.

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