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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-124-2 | CAS number: 92-09-1
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 9 October 2017
- Deviations:
- yes
- Remarks:
- Deviations: only 2 animals instead of three; in one animal the eye was washed out immediately after treatment (TG: after 24 hrs)
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(2-(4-amino-N-ethyl-m-toluidino)ethyl)methanesulphonamide sesquisulphate
- EC Number:
- 247-161-5
- EC Name:
- N-(2-(4-amino-N-ethyl-m-toluidino)ethyl)methanesulphonamide sesquisulphate
- Cas Number:
- 25646-71-3
- Molecular formula:
- C12H21N3O2S.3/2H2O4S
- IUPAC Name:
- Methanesulfonamide, N-[2-[(4-amino-3-methylphenyl)ethylamino]ethyl]-, sulfate (2:3)
1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Hra:(NZW)SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products lnc. (Denver, PA)
- Age at study initiation: at least three months old
- Weight at study initiation: at least 2000 g
- Housing: individually housed in suspended, stainless-steel mesh cages in an American Association for Accreditation of Laboratory Animal Care-accredited vivarium
- Diet: certified High Fiber Rabbit Diet (PMI® #5325) available ad libitum
- Water: local public water system available ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 46-62
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g - Duration of treatment / exposure:
- One of the treated eyes was immediately washed with running distilled water
- Observation period (in vivo):
- Eyes were observed immediately after instillation of the test substance and 1, 24, 48, and 72 hours, and 7, 14, 21, and 28 days thereafter.
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: One of the treated eyes were immediately washed with running distilled water.
SCORING SYSTEM: Graded as described in OECD Guideline 405 (Annex V., Test B.5) (Grading for Ocular Lesions)
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- unwashed eyes
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Remarks:
- unwashed eyes
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- unwashed eyes
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 28 days
- Irritation parameter:
- chemosis score
- Remarks:
- unwashed eyes
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- For the unwashed eye, chemosis (grade 4) for the conjuctiva and a profuse discharge was noted one hour after administration of the test substance.
Signs of irritation for the unwashed eye between the 24 and 72 hour examination included corneal opacity (grade 1), redness of the conjunctiva (grade 3) and chemosis (grade 3) of the nictitating membrane/or lids. In addition, staining of the cornea and conjunctiva were apparent for the unwashed eye when fluorescein dye was applied at the 24-hour examination. Since the test substance caused significant ocular lesion within 72 hours after exposure which persisted for more than 24 hours, these changes were considered sufficient to characterize the response as irritating to eyes. Effects of rinsing or washing: Immediate irrigation of the eye was palliative. For the washed eye, signs of irritation were limited to redness (grade 2) and chemosis (grade 2). A profuse discharge was also seen one hour after administration of the test substance. No staining was evident when fluorescein dye was applied. By Day 7 of the study, the washed eye appeared normal.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS Category 1 (H318) according to Regulation (EC) No 1272/2008
- Conclusions:
- In an in vivo eye irritation study (OECD 405), significant irritation was observed that was not reversible until day 21 of the study. The available data on eye irritation of the substance meet the criteria for classification as serious eye damage/eye irritation Cat. 1 (H318) according to Regulation (EC) 1272/2008.
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.