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Diss Factsheets
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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Remarks:
- and in vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
No pathological changes on the treated skin of male and female rats were found in a acute dermal toxicity test at a dose of 2000 mg/kg.
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-09-12 - 2014-12-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study under GLP without relevant deviations on the registered substance itself.
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- valid from 2014-07-11
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Wistar (Crl: WI(Han); outbred)
- Sex:
- male/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 (males), 8 weeks (females)
- Weight at study initiation: average 280 g (males), 213 g (females)
- Fasting period before study: no
- Housing: The animals were housed in plastic cages covered with wire bar lids. The dimensions of cages were 58 x 37 x 21 cm (length x width x height). After application of the test item, each animal was housed individually. After the removal of the test item from the animals’ skin, there were five rats per cage. Each sex was kept separately. 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 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunks
- % coverage: 10% of the body surface area
- Type of wrap if used: The test item was applied to gauze patches. The patches were laid on the prepared skin and covered with PVC foil. An elastic bandage and a sticking plaster were used to make a circular protecting band.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: no - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation of all animals for mortality and morbidity was conducted twice a day or once a day (on days off). The detailed clinical observations were made on the application day (day 0) at hourly intervals up to 5 hours. From the 1st to the 14th day of the experiment, the detailed clinical observations were performed once a day.
- Necropsy of survivors performed: The detailed gross examination comprised the 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 - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: All animals survived the single application of 2000 mg/kg bw.
- Mortality:
- All animals survived the experiment.
- Clinical signs:
- Following single application of the test item, the animals did not show any general clinical signs. No pathological changes on the treated skin were found in males and females.
- Body weight:
- During the 14-day experiment, body weight gain was found in all animals.
- Gross pathology:
- The gross examination did not reveal any pathological changes in the examined animals.
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- The study was conducted under GLP according to OECD guideline 402 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 application of 3-(Cyclohexylamino)-propane sulfonic acid at a dose of 2000 mg/kg bw, the animals did not show any general clinical signs. No pathological changes on the treated skin of males and females were found. All animals survived the experiment. During the 14-day experiment, body weight gain was found in all animals. Gross examination did not reveal any pathological changes in the examined animals. So it may be stated that the median lethal dose (LD50) of 3-(Cyclohexylamino)-propane sulfonic acid is greater than 2000 mg/kg b.w. Since no animal showed at no observation time any pathological changes on the treated skin or other signs of irritation, it may be concluded that, under the conditions of this test, 3-(Cyclohexylamino)-propane sulfonic acid, does not need to be considered as irritating to rat skin.
According to the Regulation (EC) No. 1272/2008, it may be concluded that 3-(Cyclohexylamino)-propane sulfonic acid is beyond categorization. - Executive summary:
In an acute dermal toxicity study (OECD 402), groups of 8-9 weeks old Wistar (Crl: WI(Han); outbred) rats (5/sex) were dermally exposed to unchanged 3-(Cyclohexylamino)-propane sulfonic acid for 24 hours on 10% of body surface area at a dose of 2000 mg/kg bw under occlusive coverage. Animals then were observed for 14 days.
Following single application of the test item, the animals did not show any general clinical signs. No pathological changes on the treated skin of males and females were found. All animals survived the experiment. During the 14-day experiment, body weight gain was found in all animals. Gross examination did not reveal any pathological changes in the examined animals. Hence, the following results could be gained:
LD0(dermal) ≥ 2000 mg/kg bw
LD50(dermal) > 2000 mg/kg bw
3-(Cyclohexylamino)-propane sulfonic acid is of lowToxicity based on the LD50 determined. Since no animal showed at no observation time any pathological changes on the treated skin or other signs of irritation, it may be concluded that, under the conditions of this test, 3-(Cyclohexylamino)-propane sulfonic acid does not need to be considered as irritating to rat skin.
According to Regulation (EC) No. 1272/2008, it may be concluded that 3-(Cyclohexylamino)-propane sulfonic acid is beyond categorization.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.
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