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Diss Factsheets
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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 Jan-11 Feb 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- Principles of method if other than guideline:
- - Principle of test: Test doses were determined based on an initial "viability test" conducted at 5000 mg/kg bw. Doses administered via gavage were 1200, 300, and 75 mg/kg bw, based on initial fasted body weights to groups of four young male rats per dose level, which were then observed for mortality and clinical signs of toxicity daily for up to 7 days following administration.
- Short description of test conditions: Standard acute oral toxicity testing under controlled laboratory conditions, at three dose levels, with necropsy 7 days after administration. Dead animals were necropsied as soon as possible to try to ascertain the cause of death.
- Parameters analysed / observed: Body weights, food consumption, water consumption, clinical observations of toxicity and mortality. - GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
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)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CRJ-F344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Labouratories Japan, Inc.
- Age at study initiation: 6-wk
- Weight at study initiation: 105.5 ± 5.17 g
- Fasting period before study: from 16 h before dosing to 6 h after administration
- Housing: individually in five-modular stainless steel cages with barrier system
- Diet: solid feed NMF, Oriental Yeast Co., Ltd., autoclave sterilized, ad libitum
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 28 Jan 1982 To: 11 Feb 1982
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 7.5, 30 and 120 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
Dose range-finding study:
- Rationale for the selection of the doses: A "viability test" was conducted at 5000 mg/kg bw - Doses:
- 75, 300 and 1200 mg/kg bw
- No. of animals per sex per dose:
- 4 males/dose
- Control animals:
- other: one control group was tested for all 9 test compounds
- Details on study design:
- - Duration of observation period following administration: 7 days after dosing
- Frequency of observations and weighing: Observations for clinical signs of toxicity and mortality were conducted on the day of dosing immediately after dosing, 1, 2, 4, 6 and 8 h post-dose, and at the same time each morning on days 1 to 7 after dosing. Food consumption and water consumption were measured on Days 1, 2, 3, 5 and 7 after dosing. Body weights were measured on the day of dosing (fasted, prior to administration), and 1, 2, 3, 5 and 7 days after dosing.
- Necropsy of survivors performed: yes - Statistics:
- Means with SD were calculated for body weights, food consumption and water consumption.
Results and discussion
- Preliminary study:
- A viability test was conducted on 9 test articles via oral administration of 5000 mg/kg bw using rats, prior to conduct of this LD50 study.
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 75 - < 300 mg/kg bw
- Mortality:
- 75 mg/kg bw: 0/4 males died
300 mg/kg be: 3/4 males died
1200 mg/kg bw: 3/4 males died - Clinical signs:
- 75 mg/kg bw: piloerection in 4/4 males (2-6 h post-dose)
300 mg/kg bw: piloerection and lacrimation in 4/4 males (2 h post-dose); convulsion, cyanosis, respiratory depression, and death in 2/4 males (day of dose); cyanosis, piloerection and lacrimation in 1/4 males (4-8 h post-dose) then piloerection, hunched posture and hypothermia (Day 1 and 2 post-dose) followed by death (Day 3 post-dose).
1200 mg/kg bw: lacrimation in 4/4 males (30 minutes post-dose); lacrimation, piloerection and salivation in 4/4 males (2 h post-dose); convulsions and respiratory paralysis followed by death in 1/4 males (day of dosing); in addition to the previous clinical signs, hunched posture in 2/4 males (4 h post-dose) followed by prostrate position (8 h post-dose) and death (Day 1 post-dose). - Body weight:
- 75 mg/kg bw: similar body weight gain to control group throughout the study
300 mg/kg bw: body weight loss after dosing until Day 2 post-dose, and then a gain in body weight throughout the study, but lower overall than control group, indicating no complete recovery of body weight.
1200 mg/kg bw: body weight loss after dosing until Day 2 post-dose, and then a gain in body weight throughout the study, but lower than control group, indicating no complete recovery of body weight. - Gross pathology:
- At the necropsies of the animals found dead during the study period, atrophy of the stomach and exfoliation of gastric mucosa were noted. During the necropsies conducted at termination of the study, no abnormalities were found.
- Other findings:
- Food consumption
75 mg/kg bw: similar trend with control group
300 and 1200 mg/kg bw: decreased food consumption throughout the study compared to control group
Water consumption
75 mg/kg bw: similar trend with control group
300 and 1200 mg/kg bw: decreased water consumption through Day 2 post-dose, then recovering to the control group level throughout the remainder of the study
Any other information on results incl. tables
Mortality and Clinical Signs for CD-3 Acute Oral Toxicity Study in Rats
Dose [mg/kg bw] |
Mortality |
Clinical Signs |
Na |
Na |
|
Males |
||
0 |
0/4 |
0/4 |
75 |
0/4 |
4/4 |
300 |
3/4 |
4/4 |
1200 |
3/4 |
4/4 |
aNumber of animals dosed
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS Category 3 (H301) according to Regulation (EC) No 1272/2008
- Conclusions:
- The test substance CD-3 when administered at a dose level of 75 mg/kg bw produced no deaths in 4 dosed animals, however at a dose level of 300 mg/kg bw, 3 of 4 dosed animals died.
Therefore, in this study an LD50 value greater than 75 mg/kg bw but smaller than 300 mg/kg bw was found for CD-3, giving a Acute Tox. Hazard Category 3 classification.
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