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EC number: 214-492-1 | CAS number: 1135-40-6
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-09-12 to 2014-12-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study under GLP without relevant deviations on the registered substance itself.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- valid from 2014-07-11
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 3-(Cyclohexylamino)-propane sulfonic acid
- IUPAC Name:
- 3-(Cyclohexylamino)-propane sulfonic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): 3-(Cyclohexylamino)-propane sulfonic acid
- Substance type: Pure compound
- Purity test date: 2014-09-03
- Batch No.: 08140015/107
- Expiration date of the lot/batch: 2017-08-15
- Storage condition of test material: in a container made of plastic, at temp. 15-25°C
- Other: Date of production: 2014-08-13
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar (Crl: WI(Han); outbred)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Experimental Medicine Centre at the Medical University in Białystok
- Age at study initiation: 9 weeks (sighting study) / 10 weeks (main study)
- Weight at study initiation: 207-228 g
- Fasting period before study: yes, approx. 19h
- Housing: The animals were kept in plastic cages covered with wire bar lids. The dimensions of cages were 58 x 37 x 21 cm (length x width x height). In the sighting study, the animal was caged individually. In the main study, there were four animals in one cage. UV-sterilized wood shavings were used as bedding
- Diet (e.g. ad libitum): “Murigran” standard granulated laboratory fodder produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz (Batch No 3/14 and 4/14) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24 °C
- Humidity (%): 40 – 85%
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 60 mg/mL or 400 mg/mL
- Amount of vehicle (if gavage): 0.5 mL / 100 g bw
MAXIMUM DOSE VOLUME APPLIED: 0.5 mL / 100 g bw - Doses:
- 300 mg/mL or 2000 mg/mL
- No. of animals per sex per dose:
- 1 animal (each for gavage of 300 or 2000 mg/kg bw in sighting study)
4 animals (main study) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation of all animals for morbidity and mortality was conducted twice a day or once a day (on days off). The detailed clinical observations were performed on the day of test item administration (day 0), i.e. 10, 30, and 60 minutes after the administration and then at hourly intervals up to the 5th hour after the administration. From the 1st to the 14th day of the experiment, the detailed clinical observations were performed once a day.
- Necropsy of survivors performed: gross examination comprised an observation of the external body surface, all natural apertures, and the cranial, thoracic, and abdominal cavities with their contents
- Other examinations performed: clinical signs, body weight
Results and discussion
- Preliminary study:
- Following single administration of test item at a dose of 300 mg/kg b.w. to the first animal used in the sighting study, no changes were found in the animal during the entire period of observation. The animal survived the experiment.
Following single administration of test item at a dose of 2000 mg/kg b.w. to the second animal used in the sighting study, no changes were found in the animal during the entire period of observation. The animal survived the experiment.
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Remarks on result:
- other: All 5 animals given 2000 mg/kg survived the experiment
- Mortality:
- Following single administration of test item at a dose of 2000 mg/kg b.w. to all five animals, no changes were found in the animals during the entire period of observation. All animals survived the experiment.
- Clinical signs:
- Following single administration of test item at a dose of 2000 mg/kg b.w. to all five animals, no changes were found in the animals during the entire period of observation.
- Body weight:
- During the 14-day experiment, body weight gain was found in all animals.
- Gross pathology:
- No lesions were found at gross necropsy of all animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- The study was conducted under GLP according to OECD guideline 420 on the registered substance itself. The method is to be considered scientifically reasonable with no deficiencies in documentation. Hence, the results can be considered as reliable to assess the acute oral toxicity in rats.
Following single administration of 3-(Cyclohexylamino)-propane sulfonic acid at a dose of 2000 mg/kg b.w. to five female rats no signs of toxicity were found. All animals survived the period of experiment. After the experiment, body weight gain was found in all animals. Gross examination did not reveal any lesions in animals, which leads in summary to the following results: LD0(oral) ≥ 2000 mg/kg bw; LD50(oral) > 2000 mg/kg bw.
On the grounds of the obtained results, 3-(Cyclohexylamino)-propane sulfonic acid, can be classified to the following categories:
- category 5 / unclassified – according to the Globally Harmonized System (GHS),
- agents which are beyond categorization – according to the Regulation (EC) No. 1272/2008 - Executive summary:
In an acute oral toxicity study (OECD 420), fasted, 9-10 week old female Wistar (Crl: WI(Han); outbred) rats were given a single oral dose of 3-(Cyclohexylamino)-propane sulfonic acid in water at doses of 300 mg/kg bw (1 female, sighting study) or 2000 mg/kg bw (1 female, sighting study, 4 females, main study) and observed for 14 days.
Following single administration of the test item at a dose of 2000 mg/kg b.w. to all animals used in the main study no signs of toxicity were found. All animals survived the period of experiment. After the experiment, body weight gain was found in all animals. Gross examination did not reveal any lesions in animals. Hence, the following results could be gained:
LD0(oral) ≥ 2000 mg/kg bw
LD50(oral) > 2000 mg/kg bw
3-(Cyclohexylamino)-propane sulfonic acid is of low Toxicity based on the LD50 determined. 3-(Cyclohexylamino)-propane sulfonic acid, can be classified to the following categories:
- category 5 / unclassified – according to the Globally Harmonized System (GHS),
- agents which are beyond categorization – according to the Regulation (EC) No. 1272/2008
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