Registration Dossier
Registration Dossier
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: 424-510-1 | CAS number: 220150-59-4
- 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:
- From 24. Aug. to 07. Sep. 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 424-510-1
- EC Name:
- -
- Cas Number:
- 220150-59-4
- Molecular formula:
- not applicable for UVCB substance
- IUPAC Name:
- Reaction products of Phenol, 2,4-dinitro-, sulfurized, leuco derivatives and (3-chloro-2-hydroxypropyl)trimethylammonium chloride
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, 4414 Füllinsdorf, CH
- Gender: male and female; females nulliparous and non-pregnant
- Age at study initiation: males: 8 weeks; females: 11 weeks
- Weight at study initiation: males: 197 to 219 g; females: 173 to 189 g
- Fasting period before study: approximately 16 hours
- Housing: standard laboratory conditions. Groups of five in Makrolon type-4 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, 4132 Muttenz, CH)
- Diet: ad libitum; palleted standard Kliba 343, batch numbers 86/95 and 65/95 rat maintenance diet ("Kliba", Klingentalmühle AG, 4303 Kaiseraugst, CH) (analytical test report demonstrates suitability)
- Water: ad libitum; community tap water from Füllinsdorf (bacteriological assay and chemical water analysis demonstrated suitability)
- Acclimation period: one week after bill of good health
ENVIRONMENTAL CONDITIONS
- Temperature: 21 to 23 °C
- Humidity: 54 to 76 %
- Air changes: 10 to 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- bi-distilled water
- Details on oral exposure:
- DOSAGE PREPARATION
- The test item was placed into a glass beaker on a tared Mettler PM 480 balance, and the vehicle was added. A weight by volume dilution was prepared using a homogeniser (Ultra-Turrax, Janke & Kunkel, 79219 Staufen, Germany).
- Homogenelty of the test article in the vehicle was maintained during treatment using a magnetic stirrer (Janke & Kunkel. 79219 Staufen, Germany). The preparation was made shortly before dosing.
TREATMENT
- The animals received a single dose of the test article on a mg/kg body weight basis by oral gavage following fasting (access to water was not interrupted). Food was provided again approximately 3 hours after dosing.
- Application volume: 10 mL/kg bw. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Males: 5
Females: 5
Total: 10 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations: four times during test day 1, then daily during days 2-15
- Frequency of weighing: test days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: All animals were examined macroscopically. All animals were killed by intraperitoneal injection of 2.0 mL/kg bw NARCOREN (Rhone Merieux GmbH, 88471 Laupheim, Germany) equivalent to 320 mg/kg bw sodium pentobarbitone and sacrificed by exsanguination.
- Observations recorded: mortality, body weights, macroscopic findings, clinical signs
CLINICAL SIGNS
General behaviour: aggressiveness, vocalisation, restlessness / excitation, nervousness, fear, sedation, somnolence, sleep, coma
Respiration: apnoea, dyspnea, rales
Eye: chromodacryorrhoea, exophthalmos, miosis, mydriasis, whitish discharge, lid adhesion, lacrimation, negative corneal reflex
Nose: rhinorrhoea, epistaxis
Motility: akinesia, ataxia, dropped head, hyperkinesia, hypokinesia, paralysis (flaccid), paralysis (spastic), paddling movements, stiff gait, rolling movements
Body posture: ventral body position, latero-abdominal position, hunched posture
Motor susceptibility: spasms, tonic muscle spasms, clonic muscle spasms, opisthotonus, saltatory spasms, trismus, tremor, muscle-twitching, muscle-twitching (generalised)
Skin: erythema, oedema, necrosis
Various: loss of weight, emaciation, diarrhoea, ruffled fur, salivation, pallor, cyanosis - Statistics:
- The LOGIT-Model could not be used as no death occurred.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 0 % of males at 2000 mg/kg bw
0 % of females at 2000 mg/kg bw - Clinical signs:
- other: No clinical signs of toxicity were observed during the observation period.
- Gross pathology:
- Macroscopic findings: No macroscopic findings were noted.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classifed according to the CLP criteria (EC 1272/2008)
- Conclusions:
- The LD50 (oral, rat) of test item was found to be greater than 2000 mg/kg bw.
- Executive summary:
Acute oral toxicity of the substance was evaluated in an experimental study that was performed according to the OECD Guideline 401 (1987) and EU method B.1 (1992). The test item was administered to 10 rats (5 male, 5 female) by oral gavage, at 2000 mg/kg bw. 0 % death rate was observed. The LOGIT-Model could not be applied to these data. No clinical signs or gross pathology findings were observed. The acute oral toxicity of the test item in rats of both sexes, observed over a period of 15 days, was estimated to be: greater than 2000 mg/kg bw. Therefore, it can be extrapolated that the LD50 is greater than 2000 mg/kg bw.
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.
