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EC number: 241-443-1 | CAS number: 17418-59-6
- 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:
- 12 May 2021 to 28 May 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-amino-4-hydroxy-2-(2-phenoxyethoxy)anthraquinone
- EC Number:
- 241-443-1
- EC Name:
- 1-amino-4-hydroxy-2-(2-phenoxyethoxy)anthraquinone
- Cas Number:
- 17418-59-6
- Molecular formula:
- C22H17NO5
- IUPAC Name:
- 1-amino-4-hydroxy-2-(2-phenoxyethoxy)-9,10-dihydroanthracene-9,10-dione
- Test material form:
- solid: particulate/powder
- Details on test material:
- Physical state: Red powder
Storage condition: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 10-11 weeks (first and second step)
- Weight at study initiation: 198 - 208 g (first step); 206 - 207 g (second step)
- Fasting period before study: Yes (The day before treatment the animals were fasted. The food but not water was withheld overnight. Animals were weighed before the application and the food was given back 3 hours after the treatment.)
- Housing: Group caging (3 animals/cage). Type III polypropylene/polycarbonate cage.
- Diet: ad libitum
- Water: tap water from municipal supply, ad libitum
- Acclimation period: 27 days (first step); 28 days (second step)
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: above 10 air exchanges/hour
- Photoperiod: 12 hours light daily, from 6.00 a.m. to 6.00 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Helianthi annui oleum raffinatum
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): treatment volume of 10 mL/kg bw
- Justification for choice of vehicle: not specified
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
DOSAGE PREPARATION
Formulations were prepared just before the administration and were stirred continuously during the treatment.
CLASS METHOD
The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animals died in first step, so further three female rats were treated with the same dose. No animals died in second step, too, so the test was finished, because the stopping criteria of Annex 2d of OECD Guideline No. 423 was met. - Doses:
- 2000 mg/kg bw (female)
- No. of animals per sex per dose:
- 3 animals per group
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually (for mortality) after dosing at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h after the treatment and twice each day for 14 days thereafter. Their general state, external appearance, behaviour and clinical symptoms were also assessed individually. Indeed, individual observations were performed on the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Necropsy of survivors performed: Yes (necropsy on the treatment day and Day 15)
After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed, and any abnormality was recorded with details of its location, colour, shape and size.
- Other examinations performed: The body weights were also recorded on day 0 (just before the treatment), on day 1, on day 7 and on day 15 with a precision of 1 g.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No death occurred after the single 2000 mg/kg bw oral dose of the test material
- Mortality:
- No death occurred at 2000 mg/kg bw single oral dose of the test material. All female rats in step 1 and step 2 survived until the end of the 14-day observation period.
- Clinical signs:
- other: no treatment related symptoms were observed throughout the 14-day post-treatment period
- Body weight:
- other body weight observations
- Remarks:
- The mean body weight of animals treated with 2000 mg/kg bw dose corresponded to their species and age throughout the study.
- Gross pathology:
- All animals treated with 2000 mg/kg bw dose survived until the scheduled necropsy on Day 15. No pathological changes were found related to the effect of the test material during the macroscopic examination of animals treated with 2000 mg/kg bw dose.
- Other findings:
- No death occurred after the single 2000 mg/kg bw oral dose of test material. There were no toxic clinical signs and no test material related effect found in body weights and body weight gains during the study. Autopsy revealed no treatment related pathological changes.
Any other information on results incl. tables
Overall results
Dose (mg/kg bw) | Mortality (dead/treated) | LD50 (mg/kg bw) | GHS category |
2000 | 0/6 | above 5000 | 5 or unclassified |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to EU criteria
- Conclusions:
- Under the conditions of this study, the LD50 of the test material was found to be >5000 mg/kg bw in rats.
- Executive summary:
The acute oral toxicity of the test material was investigated according to OECD Guideline 423 in accordance with GLP using the acute toxic class method. This method involved a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animals died in the first step, so a further three female rats were treated with the same dose. No animals died in second step, too, so the test was finished, because the stopping criteria of Annex 2d of OECD Guideline No. 423 was met.
Therefore, under the conditions of this study, the LD50 of the test material was found to be >5000 mg/kg bw in rats.
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