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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 23. Aug. 1995 to 06. 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 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- 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
- Remarks:
- Hanlbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wolferstrasse 4, 4414 Füllinsdorf, CH
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: males: 8 weeks; females: 11 weeks
- Weight at study initiation: males: 220 to 239 g; females: 187 to 213 g
- Fasting period before study: not specified
- Housing: acclimatisation: in groups of five in Makrolon type-4 cages; during treatment and observation: individually in Makrolon type-3 cages. Autoclaved standard softwood bedding ("Lignocel", Schill AG, 4132 Muttenz, CH).
- Diet: ad libitum; pelleted standard Kliba 343, batch nos. 86/95 and 65/95 rat maintenance diet ("Kliba", Klingentalmühle AG, 4303 Kaiseraugst, CH). Results of analyses for contaminants included in report.
- Water: ad libitum; community tap water from Füllinsdorf. Bacteriological, chemical and contaminant analyses included.
- Acclimation period: one week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
- Identification: by unique cage number and corresponding colour-coded spots on the tail
- Randomisation: randomly selected at the time of delivery into groups of five
ENVIRONMENTAL CONDITIONS
- Temperature: 21.5 to 23 °C
- Humidity: 54 to 76 %
- Air changes: 10 to 15 per hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- bi-distilled water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area, clipped one day before test item application
- Coverage: 10 % of body surface area
- Type of wrap if used: semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing: washed with lukewarm tap water and dried with disposable paper towels
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: 4 mL/kg bw
- Concentration: 2000 mg/kg bw
- Constant volume used: no
- Constant concentration used: yes
- For solids, paste formed: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Males (2000 mg/kg bw): 5
Females (2000 mg/kg bw): 5
Total: 10 - Control animals:
- no
- Details on study design:
- - Observations: clinical signs, body weight, mortality, pathological change
- Duration of observation period following administration: 14 days
- Frequency of observations: four times during test day 1 then daily during days 2 to 15
- Frequency of weighing: on test days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes. Necropsies were performed by experienced prosectors. At the end of the observation period all animals were anaesthetised by intraperitoneal injection of NARCOREN (Rhone Merieux GmbH, 88471 Laupheim, Germany) at a dose of at least 2.0 ml/kg bw (equivalent to at least 320 mg/kg sodium pentobarbitone /kg bw) and sacrificed by exsanguination. The animals were examined macroscopically.
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 deaths occurred.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study period.
- Clinical signs:
- other: There were no clinical signs of systemic toxiclty. The skin was discoloured with blue at the application site in all animals. The staining persisted on test days 2 to 15. In one male animal the blue discoloured skin was observed until test day 8.
- Gross pathology:
- No macroscopic findings were noted.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP criteria (EC 1272/2008)
- Conclusions:
- The LD50 (dermal, rat) of test item was found to be greater than 2000 mg/kg bw.
- Executive summary:
Acute dermal toxicity of the test item was evaluated in an experimental study that was performed according to the OECD Guideline 402 (1987) and EU method B.3 (1992). 2000 mg/kg bw of the test item was applied dorsally to 10 rats of both sexes for a duration of 24 hours.
A death rate of 0 % at 2000 mg/kg bw was observed. Local discolouration was observed between 24 hours and end of observation period. The LOGIT-Model could not be applied to these data. The acute dermal 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 (dermal, rat) is greater than 2000 mg/kg bw.
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