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EC number: 247-161-5 | CAS number: 25646-71-3
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 Oct - 12 Nov 1997
- 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:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- yes
- Remarks:
- occlusive dressing instead of semi-occlusive dressing
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- 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:
- bis(N-{2-[(4-amino-3-methylphenyl)(ethyl)amino]ethyl}methanesulfonamide); tris(sulfuric acid)
1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sprague-Dawley® rats [SAS:V AF®(SD)] obtained from SASCO, Inc., Stone Ridge (Kingston), NY
- Age at study initiation: male rats were 8 weeks of age and female rats were 10 weeks of age
- Weight at study initiation: male rats weighed 206 to 220 grams and female rats weighed 210 to 214 grams
- Housing: Animals were housed in an American Association for Accreditation of Laboratory Animal Care-accredited vivarium·in accordance with the Guide for the Care and Use of Laboratory Animals, singly housed in suspended, stainless-steel, wire mesh cages. Cages and racks were washed once a week. Absorbent paper, used to collect excreta, was changed at least three times a week.
- Diet: Certified Rodent Diet (Purina Rodent Chow #5002, pellets) was available ad libitum.
- Water: ad libitum through an automatic watering system. The source of the water was the local public water system. There have been no contaminants identified in periodic water analyses that would be expected to interfere with the conduct of the study. Semi-annual analyses of water are maintained on file within the testing laboratory.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 48-62
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The hair was removed from an area of the dorsal skin with an electric clipper. A single
dose of the test substance was placed in contact with the skin using a fiber pad.
- Type of wrap if used: occlusive wrap
REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the exposure period, any residual test material was removed with running water.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw, The test substance was administered as a solid moistened thoroughly with water.
VEHICLE
- Amount(s) applied: The test substance was administered as a solid moistened thoroughly with water. - Duration of exposure:
- 24 hours
At the end of the exposure period, any residual test material was removed with running water. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female rats per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were measured on Days O (prior to treatment), 7, and 14.
- Necropsy of survivors performed: yes, All animals were euthanatized and necropsied at the completion of the 14-day observation period.
- Other examinations performed: Animals were observed at least once during the exposure period, and once each day thereafter for the duration of the experiment. Observations included, but were not limited to, examination of the hair, skin, eyes, mucous membranes, motor activity, feces, urine, respiratory system, circulatory system, autonomic nervous system, central nervous system, and behavior patterns. - Statistics:
- No statistical procedures were required during the study.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- In the dermal toxicity study, no mortality was noted.
- Clinical signs:
- other: Discoloration (Black) of the hair was observed immediately adjacent to the application site in all rats (male and female).
- Gross pathology:
- Treatment-related changes seen at necropsy were limited to discoloration (black) of the hair adjacent to the application site of all animals. Hydrometra was an incidental finding noted in one female rat. No tissue was collected for microscopic examination.
No signs of organ toxicity were observed. All rats survived until scheduled sacrifice at the end of the observation period.
Any other information on results incl. tables
Table 1: Overview Results
Dose |
Number of rats (male/female) |
Number of Deaths after 14 days (male/female) |
2000 mg/kg bw |
5/5 |
0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: no classification required according to Regulation (EC) 1272/2008.
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test substance in male and female Sprague-Dawley strain rats was > 2000 mg/kg bw.
The available data on acute dermal toxicity of the test substance do not indicate requirement of classification 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.
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