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EC number: 250-466-6 | CAS number: 31098-21-2
- 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:
- 23 January - 12 February 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted May 12, 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- EWG Directive 84/449/EWG, Amtsblatt der Europaeischen Gemeinschaften L 251, Jahrgang 27, 19.9.84, B.1. Akute Toxizitaet - oral /96
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- The study was performed in compliance with OECD Principles of Good Laboratory Practice (see Bundesanzeiger Nr. 42a, 2nd March 1983, FRG).
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Potassium 3-sulphopropyl methacrylate
- EC Number:
- 250-466-6
- EC Name:
- Potassium 3-sulphopropyl methacrylate
- Cas Number:
- 31098-21-2
- Molecular formula:
- C7H12O5S.K
- IUPAC Name:
- potassium 3-(methacryloyloxy)propane-1-sulfonate
- Test material form:
- solid
- Details on test material:
- - Physical state: solid
- Stability under test conditions: stable as pure test article , article dilution stable for at least 2 hours
- Storage condition of test material: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: KFM-Han. Wistar (outbred, SPF-Quality)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG , 4414 Fuellinsdorf , Switzerland
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: males : 234-294 g , females : 184-210 g
- Fasting period before study: 12-18 hours before treatment , approximately 1 hour after treatment
- Housing: animals were caged in groups of five in Macrolon cages type 3 with standard softwood bedding
- Diet (e.g. ad libitum): pelleted standard Kliba 343 , Batch 36/85 rat maintenance diet , ad libitum
- Water (e.g. ad libitum): tap water , ad libitum
- Acclimation period: 1 week under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 14-15
- Photoperiod (hrs dark / hrs light): 12/12
IDENTIFICATION: by unique cage number and corresponding colour-coded spots
RANDOMIZATION: animals were randomly selected at time of delivery in groups of five.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 4% solution of CMC in distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle : 4% solution of CMC, carboxymethylcellulose sodium salt purum (Fluka AG) in distilled water
- Amount of vehicle (if gavage): Group 1 : 10 ml at 1000 mg/kg ; Group 2 : 20 ml at 5000 mg/kg
MAXIMUM DOSE VOLUME APPLIED : 20 ml at 5000 mg/kg
DOSAGE PREPARATION (if unusual):
The test article was placed into a glass beaker an a tared Mettler PK 4800 balance, and the vehicle (4 % solution of CMC, carboxymethylcellulose sodium salt purum, Fluka AG, CH 9470 Buchs / Switzerland in distilled water) was added. A weight by volume dilution was prepared using a homogenizer (Ultra-Turrax, Janke and Kunkel, Staufen, FRG).Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer (Auer-Bittmann, Switzerland) . The preparation was made immediately prior to dosing. - Doses:
- 1000 mg/kg bw and 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
Mortality : Four times during test day 1, and daily during days 2-15
Body weight : Test days 1 (pre-administration) , 8 and 15
Symptoms : Each animal was examined for changes in appearance and behaviour four times during day 1, and daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed : All animals were necropsied . All animals were killed by intraperitoneal injection of sodium pentobarbitone.
- Other examinations performed: other:
The animals were checked for the symptoms listed below .
- General behaviour : aggressive,crying,restlessness/excitation,nervousness,fear,sedation,somnolence,sleep,coma
- Respiration : apnea,dyspnea,rales
- Eye : chromodacryorrhea,exophthalmos,miosis,mydriasis,whitish discharge,lid adhesion,lacrimation
- Nose : rhinorrhea,epistaxis
- Motility : akinesia,ataxia,drooped head,hyperkinesia,hypokinesia,paralysis flaccid,paralysis spatic,paddling movements,stiff movements,rolling movements,hunched posture
- Body posture : ventral body position,latero-abdominal position,curved body position
- Skin : erythema,edema,necrosis
- Motor susceptibility : spasms,tonic muscle spasms,clonic muscle spasms,opisthotonus,saltatory spasms,trismus,retching,"Straub" phenomenon,tremor,muscle -twitching
- Various : loss of weight,emaciation,negative corneal reflex,diarrhea,ruffled fur,necrosis of tissue of application area,salivation,pallor,cyanosis - Statistics:
- The LOGIT-Model could not be applied to the observed rates of death. The toxicity was estimated without use of a statistical model.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- Clinical signs were noted, but no mortality
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- clinical signs were noted, but no mortality
- Mortality:
- Males and females :
0% at 1000 mg/kg
0% at 5000 mg/kg - Clinical signs:
- other: The following symptoms were observed : 1000 mg/kg : sedation,dyspnea 5000 mg/kg : sedation,dyspnea,diarrhea All rats had recovered within 3 hours to 3 days after test articIe treatment.
- Gross pathology:
- No macroscopic organ changes were observed in the animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- LD50 > 5000 mg/kg
- Conclusions:
- The study was performed according to the OECD TG401 without deviations and therefore considered to be of the highest quality (reliability Klimisch 1) and so sufficiently reliable to assess the acute oral toxicity of the test item to rats. The test material did not induce mortality up to the highest tested dose of 5000 mg/kg. The test material was hence considered to be non-toxic under the conditions of the test and not requiring classification according to Regulation (EC) 1272/2008.
- Executive summary:
The acute oral toxicity of the test material was investigated in rats. The test was conducted according to OECD TG401. As doses 1000 and 5000 mg/kg bw of the test substance were administered via gavage to the rats. Observations were made for a period of 15 days. No mortalities or signs of systemic toxicity, besides sedation and dyspnea in the 1000 mg/kg bw group and sedation,dyspnea and diarrhea in the 5000 mg/kg bw group respectively. The animals had recovered within 3 hours to 3 days after administration. No treatment-related body weight changes were reported. No pathological abnormalities were found in any of the treated animals. The acute oral medium lethal dose (LD50) of the test material in rats of both sexes observed over a period of 15 days was estimated to be greater than 5000 mg/kg bw.
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