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EC number: - | CAS number: -
- 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
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- Nanomaterial radical formation potential
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- 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 irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 06 Dec 2016 to 09 Dec 2016
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- trans-(4-(methylamino)cyclohexyl)methanesulfonic acid
- Cas Number:
- 2124221-12-9
- Molecular formula:
- C8H17NO3S
- IUPAC Name:
- trans-(4-(methylamino)cyclohexyl)methanesulfonic acid
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA
- Age at study initiation: The male animal was born on 11 Jun 2016 and the female animals were born on 04 Jun 2016.
- Weight at study initiation: The pre-test body weight range was 3.2 -3.5 kg.
- Housing: The animals were identified by cage notation and a uniquely numbered metal ear tag and individually housed in suspended wire-bottom cages.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet No. 5321) was provided daily.
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g per site and moistened with 0.4 ml of distilled water to form a pasty consistency.
- Duration of treatment / exposure:
- 3 minutes, 1 hour, 4 hours
- Observation period:
- 72 hours
- Number of animals:
- one male, two females
- Details on study design:
- TEST SITE
- Area of exposure: The test article was applied over a 2 x 3 cm gauze patch.
- % coverage:
- Type of wrap if used: Gentle pressure was applied to aid in the distribution of the test article over the prepared site. The dose patch was secured with non-irritating tape and the rabbit was gently held in place.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test site was gently washed with gauze saturated with distilled water following patch removal.
- Time after start of exposure: 3 minutes, 1 hour, 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) Exposure Site 1 of the initial animal was scored for dermal irritation immediately post-exposure and at one hour post-exposure. Sites 2 (one-hour exposure) and 3 (four-hour exposure) were scored for dermal irritation at 1, 24, 48 and 72 hours hours after patch removal.
SCORING SYSTEM:
- Method of calculation: Erythema and edema were scored according to the numerical Draize scale. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Other effects:
- Systemic Observations: No abnormal physical signs were observed.
Body Weights: One animal gained weight and two animals' weights remained the same by study termination.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not irritating to rabbit skin.
- Executive summary:
The study is performed according to OECD Guideline 404 using rabbits. It is concluded the test item is not irritating to rabbit skin.
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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