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EC number: 279-919-6 | CAS number: 82205-20-7
- 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:
- 1984-10-23 to 1984-12-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- [2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium acetate
- EC Number:
- 279-919-6
- EC Name:
- [2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium acetate
- Cas Number:
- 82205-20-7
- Molecular formula:
- C21H29ClN5O3.C2H3O2
- IUPAC Name:
- N-{2-[{4-[(2-chloro-4-nitrophenyl)diazenyl]phenyl}(ethyl)amino]ethyl}-2-hydroxy-N,N-dimethylpropan-1-aminium acetate
- Test material form:
- liquid
- Details on test material:
- see below
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Bor: WISW (SPF CpB)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 weeks (males), 14 weeks (females)
- Weight at study initiation: males: 174 g, females: 173 g
- Fasting period before study: 16 hours before and 4 hours after application
- Housing: 5 animals in macrlon cage type III
- Diet (e.g. ad libitum): Altromin R 1324, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5
- Humidity (%): 60 +/- 5
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: not specified
- Doses:
- 2.0, 3.1, 3.5, 4.0, 5.0, 6.3 mL/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: at least twice a day (weekends once a day)
- Frequency of weighing: before application and after 14 days
- Necropsy of survivors performed: yes
- Statistics:
- LD50 calculations were performed after Rosiello AP et al., 1977 [J. Tox. and Environ. Health 3: 797-809]
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3.8 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- ca. 3.6 - ca. 4.2
- Remarks on result:
- other: Based on the density of 1.15 g/mL the LD50 value can be converted to 4370 mg/kg bw
- Mortality:
- 2.0 mL/kg bw: no mortality occurred,
3.1 mL/kg bw: 3/10,
3.5 mL/kg bw: 7/10
4.0 mL/kg bw: 7/10
5.0 mL/kg bw: 8/10
6.3 mL/kg bw: 10/10 - Clinical signs:
- In the low dose group no signs of toxicity were observed. Clinical signs of toxicity were observed for the dose groups 3.1 to 6.3 mL/kg bw. The clinical signs included reduction of spontaneous activity, piloerection and apathy.
- Body weight:
- No adverse effects observed
- Gross pathology:
- Gross pathology evaluation on dead animals of the 3.1 mL to 6.3 mL/kg bw dose groups revealed a reddish colouration of the stomach lining by the test substance. The sacrificed animals at the end of the observation period of the dose groups 2.0 to 5.0 mL/kg bw showed no adverse effects.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study, the combined LD50 of the test item was determined to be 3.8 mL/kg bw (equals 4370 mg/kg bw based on the density of 1.15 g/mL) in female and male Wistar rats. By extrapolating the concentration of 57.2% of the target substance within the mixture to 100% the calculated LD50 value would be 2500 mg/kg bw and no classification is warranted in accordance with the CLP regulation.
- Executive summary:
In an acute oral toxicity study (equivalent to OECD 401), groups of young Wistar rats (5/sex/dose) were given a single oral dose of the liquid test item (target substance content 57.2%) at doses of 2.0, 3.1, 3.5, 4.0, 5.0 and 6.3 mL/kg bw and were observed for 14 days. Mortality occurred during the first 3 days after application. At 6.3 mL/kg bw all animals died, at 5.0 mL/kg bw eight animals died, at 4.0 mL/kg bw seven animals died, at 3.5 mL/kg bw three animals died and 3.1 mL/kg bw one animal died. In the low dose group no animals died and no signs if toxicity were observed. Clinical signs of toxicity were observed for the dose groups 3.1 to 6.3 mL/kg bw. The clinical signs included reduction of spontaneous activity, piloerection, and apathy. Gross pathology evaluation on dead animals of the 3.1 mL to 6.3 mL/kg bw dose groups revealed a reddish colouration of the stomach lining by the test substance. The sacrificed animals at the end of the observation period of the dose groups 2.0 to 5.0 mL/kg bw showed no adverse effects. Based on the results, the combined oral LD50 was determined to be 3.8 mL/kg bw (equals 4370 mg/kg bw based on the density of 1.15 g/mL). By extrapolating the concentration of 57.2% of the target substance within the mixture to 100% the calculated LD50 value would be 2500 mg/kg bw.
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