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EC number: 224-244-4 | CAS number: 4263-52-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
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:
- 2 017
- 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
- 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
Constituent 1
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 |
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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