Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 237-572-8 | CAS number: 13845-18-6
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 28 June 2011 and 26 July 2011.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Sodium Sulphamate
- IUPAC Name:
- Sodium Sulphamate
- Details on test material:
- Sponsor's identification:Sodium SulphamateDescription:white solidBatch Number: LE12568Purity: 99.67%Date received:06 May 2011Expiry date:06 May 2013Storage conditions:room temperature in the dark over silica gel
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Female Wistar (RccHan:WIST) strain rats were supplied by Harlan Laboratories UK Ltd., Oxon, UK.- Age at study initiation: Eight to twelve weeks of age- Weight at study initiation: 157 - 184 g (bodyweights fell within an interval of ±20% of the mean initial bodyweight of the first treated group).- Fasting period before study: Overnight fast immediately before dosing and for approximately three to four hours after dosing- Housing: The animals were housed in groups of three in suspended solid floor polypropylene cages furnished with woodflakes.- Diet (e.g. ad libitum): Food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study.- Water (e.g. ad libitum): Free access to mains drinking water was allowed throughout the study.The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.- Acclimation period: At least five days.ENVIRONMENTAL CONDITIONS- Temperature (°C): Set to achieve limits of 19 to 25°C - Humidity (%): Set to achieve limits of 30 to 70%Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. - Air changes (per hr): At least fifteen changes per hour - Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE- Concentration in vehicle: 30 mg/ml or 200 mg/mlMAXIMUM DOSE VOLUME APPLIED: 10 ml/kgDOSAGE PREPARATION: The test item was freshly prepared, as required, as a solution at the appropriate concentration in distilled water. The test item was formulated within two hours of being applied to the test system. It is assumed that the formulation was stable for this duration. CLASS METHOD (if applicable)- Rationale for the selection of the starting dose: In the absence of data regarding the toxicity of the test item, 300 mg/kg was chosen as the starting dose.
- Doses:
- 300 mg/kg and 2000 mg/kg
- No. of animals per sex per dose:
- 3 females at 300 mg/kg. 6 females at 2000 mg/kg
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days - Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for up to fourteen days. Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment.- Necropsy of survivors performed: yes; At the end of the observation period the surviving animals were killed by cervical dislocation. All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths at 300 mg/kg bw or 2000 mg/kg bw
- Clinical signs:
- other: There were no signs of systemic toxicity at 300 mg/kg bw or 2000 mg/kg bw
- Gross pathology:
- No abnormalities were noted at necropsy at 300 mg/kg bw or 2000 mg/kg bw
Any other information on results incl. tables
Individual Bodyweights and Weekly Bodyweight Changes - 300 mg/kg
Dose Level mg/kg | Animal Number | Bodyweight (g) at Day | Bodyweight Gain (g) During Week | |||
0 | 7 | 14 | 1 | 2 | ||
300 | 1-0 Female | 184 | 200 | 205 | 16 | 5 |
1-1 Female | 183 | 190 | 199 | 7 | 9 | |
1-2 Female | 174 | 194 | 204 | 20 | 10 |
Individual Bodyweights and Weekly Bodyweight Changes - 2000 mg/kg
Dose Level mg/kg | Animal Number | Bodyweight (g) at Day | Bodyweight Gain (g) During Week | |||
0 | 7 | 14 | 1 | 2 | ||
2000 | 2-0 Female | 180 | 186 | 196 | 6 | 10 |
2-1 Female | 171 | 191 | 201 | 20 | 10 | |
2-2 Female | 175 | 183 | 197 | 8 | 14 | |
3-0 Female | 167 | 177 | 187 | 10 | 10 | |
3-1 Female | 174 | 180 | 196 | 6 | 16 | |
3-2 Female | 157 | 166 | 178 | 9 | 12 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2500 mg/kg bodyweight
- Executive summary:
Introduction.
The study was performed to assess the acute oral toxicity of the test item following a single oral administration in the Wistar strain rat. The method was designed to be compatible with the following:
- OECD Guidelines for the Testing of Chemicals No. 423 “Acute Oral Toxicity – Acute Toxic Class Method” (adopted 17 December 2001)
- Method B1 tris Acute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008
- United States Environmental Protection Agency Health Effects Test Guidelines OPPTS 870.1100 Acute Oral Toxicity, 2002
- Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 2000
Method.
A group of three fasted females was treated with the test item at a dose level of 300 mg/kg bodyweight. Based on the results from this dose level further groups of fasted females were treated at a dose level of 2000 mg/kg bodyweight. Dosing was performed sequentially.
The test item was administered orally as asolution in distilled water. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Mortality.
There were no deaths.
Clinical Observations.
There were no signs of systemic toxicity.
Bodyweight.
All animals showed expected gains in bodyweight over the study period.
Necropsy.
No abnormalities were noted at necropsy.
Conclusion.
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2500 mg/kg bodyweight (Globally Harmonised Classification System ‑ Unclassified).
The test item did not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation (CLP).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)