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EC number: 947-435-0 | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- according to GLP and OECD
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Aluminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2-sulphonate)
- EC Number:
- 278-207-2
- EC Name:
- Aluminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2-sulphonate)
- Cas Number:
- 75431-69-5
- Molecular formula:
- C20H12N2O5S.1/3Al
- IUPAC Name:
- aluminum tris(7,14-dioxo-5,7,12,14-tetrahydroquino[2,3-b]acridine-2-sulfonate)
- Reference substance name:
- 5,12-dihydroquino[2,3-b]acridine-7,14-dione
- EC Number:
- 213-879-2
- EC Name:
- 5,12-dihydroquino[2,3-b]acridine-7,14-dione
- Cas Number:
- 1047-16-1
- Molecular formula:
- C20H12N2O2
- IUPAC Name:
- 5,12-dihydroquino[2,3-b]acridine-7,14-dione
- Reference substance name:
- Dialuminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2,9-disulphonate)
- EC Number:
- 243-319-2
- EC Name:
- Dialuminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2,9-disulphonate)
- Cas Number:
- 19795-24-5
- Molecular formula:
- C20H12N2O8S2.2/3Al
- IUPAC Name:
- dialuminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2,9-disulphonate)
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Wiga GmbH, Germany
- Age at study initiation: appr. 10 weeks
- Weight at study initiation: 165 - 182 g (mean 179.7)
- Housing: single housing, Makrolon Cage, Type III
- Bedding: H 15005-29; Ssniff, Spezialdiäten GmbH, 59494 Soest, Germany
- Enrichment: Wooden Gnawing blocks (Type NGM E-022); ABEDD LAb & VET Service GmbH, 1160 Vienna, Austria
- Diet: VRF1 (P), SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least five days
- Fasting period before study: feed was withdrawn from the animals at least 16 hours before administration, but water was still available ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): appr. 10
- Photoperiod (hrs dark / hrs light): 12/12
Further Animal Information
Female Wistar (Crl:WI (Han) SPF) strain rats. On receipt the animals were randomly allocated to cages. The females were nulliparous and non pregnant. After an acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card. At the start of the study the animals were appr. 10 weeks of age. The body weight variation did not exceed ± 20% of the mean body weight of any previously dosed animals.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- Ph. Eur.
- Details on oral exposure:
- All animals were dosed once only by gavage
VEHICLE
- Concentration in vehicle: 40 % (w/v), suspension
- Amount of vehicle (if gavage): 5.00 mL/Kg bw
The homogeneity of the test item preparation during administration was ensured by stirring with a magnetic stirrer. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 animals per dose, 2 dose groups
- Control animals:
- no
- Details on study design:
- Using available information on the toxicity of the test item, 2000 mg/kg was chosen as the starting dose.
All animals were dosed once only by gavage. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing.
The animals were observed for deaths or overt signs of toxicity several times on the day of administration and at least once during each workday thereafter.
Individual body weights were recorded prior to dosing and 7 and 14 days after treatment or at death.
At the end of the observation period the surviving animals were killed by CO2 inhalation. All animals were subjected to gross pathological examination.
Data Evaluation
Data evaluations included the relationship, if any, between the exposure of the animal to the test item and the incidence and severity of all abnormalities including behavioral and clinical observations, gross lesions, body weight changes, mortality and any other toxicological effects. - Statistics:
- None recorded
Results and discussion
- Preliminary study:
- Not applicable.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 95% CL not reported
- Mortality:
- no mortality occurred in both 2000 mg/kg bw test groups.
- Clinical signs:
- other: clinical signs in the first 2000 mg/kg bw test group revealed in all animals impaired general state and piloerection from hour 2 until study day 1 after administration. clinical signs in the second 2000 mg/kg bw test group revealed in all animals impaired
- Gross pathology:
- there were no macroscopic findings in the surviving animals sacrificed at the end of the observation period (6 females).
- Other findings:
- None
Any other information on results incl. tables
Individual Body Weights and Body Weight Changes
Dose Level mg/kg |
Animal Number and Sex |
Body Weight (g) at Day |
Body Weight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
R 321 Female |
165 |
186 |
190 |
26 |
4 |
R 322 Female |
167 |
194 |
202 |
27 |
8 |
|
R 323 Female |
166 |
189 |
199 |
23 |
10 |
|
R 333 Female |
176 |
197 |
206 |
21 |
9 |
|
R 334 Female |
181 |
196 |
205 |
15 |
9 |
|
R 335 Female |
182 |
204 |
214 |
22 |
10 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Regulation (EC) 1272/2008
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was greater than 2000 mg/kg body weight. Therefore, the substance has not to be classified according to Regulation (EC) 1272/2008
- Executive summary:
Introduction
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.
Methods
A group of three fasted females was treated with the test item at a dose level of 2000 mg/kg body weight. This was followed by a further group of three fasted females at the same dose level.
The test item was administered orally as a suspension in corn oil. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
Results
Mortality. no mortality occurred in both 2000 mg/kg bw test groups.
Clinical Observations. clinical signs revealed in all animals impaired general state and piloerection from hour 1 until study day 1 after administration. There were no signs of systemic toxicity noted in all animals. Red colored staining of the feces was noted in the cages of all animals.
Body Weight. With the exception of 1 animal expected gains in body weight wer noted.
Necropsy. there were no macroscopic findings in the surviving animals sacrificed at the end of the observation period.
Conclusion
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat is greater than 2000 mg/kg body weight. Therefore, the substance has not to be classified according to Regulation (EC) 1272/2008.
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