Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 238-101-9 | CAS number: 14233-37-5
- 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 12 JULY 2018 to 11 DECEMBER 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- OECD Nº423 DEcember 2001.
OECD Guideline for testing of chemicals Acute Oral Toxicity - Acute Toxic Class Method. - Deviations:
- yes
- Remarks:
- Relative humidity/temperature in the room where the animals were housed was sporadically below/above the optimal range during the study period. This deviation was not considered to have any impact on the interpretation of the study results.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,4-bis(isopropylamino)anthraquinone
- EC Number:
- 238-101-9
- EC Name:
- 1,4-bis(isopropylamino)anthraquinone
- Cas Number:
- 14233-37-5
- Molecular formula:
- C20H22N2O2
- IUPAC Name:
- 1,4-bis[(propan-2-yl)amino]-9,10-dihydroanthracene-9,10-dione
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Colour: albino
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable): Rats are a suitable rodent species, acceptable to regulatory authorities as
indicators of potential hazards, and for which extensive background data are
available. Literature surveys of conventional LD50 tests showed that, although
there is little difference in sensitivity between the sexes, in those cases where
differences were observed females are generally slightly more sensitive
- Source: Envigo RMS Spain S.L.
- Females (if applicable) nulliparous and non-pregnant: [yes/no]: YES
- Rationale for use of males (if applicable)
- Age at study initiation: 8 weeks old
- Weight at study initiation: mean 185.277 g (183.08 (1), 189.56 (2), 183.19 (3))
- Fasting period before study: Animals were fasted overnight before administration and approx. 3-4h afterwards
- Housing:3 animals per cage after distribution. Animals were kept in groups. Enrichment devices (nesting material, tubes, chew blocks) were provided as a default husbandry practice,
- Historical data: Prior to inclusion in the study, animals were subjected to individual veterinary
examination. Only animals without clear visible sign of illness that may interfere
with the study were included.
- Diet (e.g. ad libitum): Ad libitum except for an overnight fast prior to dosing and approx. 3-4h afterwards
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days. Animals were randomly distributed by means of the body weight
stratification method. 20% of the mean body weight (for the first defined dose at
the beginning of the study and further dose steps).
- Microbiological status when known
- Method of randomisation in assigning animals to test and control groups : Animals were randomly distributed by means of the body weight stratification method.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25ºC
- Humidity (%): 30-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours
IN-LIFE DATES: From: (1) 16/07/2018 (2) 18/07/2018 To: (1) 30/07/2018 (2) 01/08/2018
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/ml
- Amount of vehicle (if gavage): The required amount of test item was weighed in an appropriate container and the corresponding volume of vehicle was added so that a final concentration
- Justification for choice of vehicle: Suitable for gavaging the rats.
- Lot/batch no. (if required): SLBT8618
- Purity: 0.5% w/v
MAXIMUM DOSE VOLUME APPLIED: 300 mg/Kg
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- 30 mg/kg bw
- No. of animals per sex per dose:
- 2 controls, 3 in dose groups.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30 minutes, 2h, 4h and daily thereafter during the 14-day observation period.
- Necropsy of survivors performed: yes
- Clinical signs including body weight: Any visible clinical signs, discomfort and mortality were recorded. Clinical signs included changes in skin, fur, eyes and mucous membranes. Alterations in respiratory pattern, behaviour, posture, response to handling and the presence of abnormal movements were reported as well. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Body weight was recorded once during the acclimatisation period for group distribution, immediately before administration for dosing purposes (from 3-4h fasted animals), weekly thereafter and prior to sacrifice. - Statistics:
- No statistical analysis was performed: all the controls survived.
Results and discussion
- Preliminary study:
- Group A and Group B were treated with a dose level of 300 mg/kg and none of the treated animals shown a test item-related mortality.
In standard conditions a next group with 3 more animals would be treated at the maximum dose level, 2000 mg/kg, according to the OECD Guideline 423, but due to problems with the insolubility of the test item at the maximum dose level it was not possible to check the mortality of a third group at 2000 mg/kg.
Therefore, it can be concluded that, according to the results obtained in this study and under the assayed experimental conditions, the test item could be ranked in the Category 4 (LD50 cut-off value of 300 < LD50 < 2000 mg/kg of body weight), of the Globally Harmonised Classification System for Chemical Substances and Mixtures.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Group A and Group B were treated with a dose level of 300 mg/kg and none of the treated animals shown a
test item-related mortality. - Clinical signs:
- other: Any visible clinical signs, discomfort and mortality were recorded. Clinical signs included changes in skin, fur, eyes and mucous membranes. Alterations in respiratory pattern, behaviour, posture, response to handling and the presence of abnormal movement
- Gross pathology:
- There weren't reatment related effects.
- Other findings:
- - Organ weights: Any remaining protocol tissues, which have been examined, have no visible lesions.
- Histopathology: Any remaining protocol tissues, which have been examined, have no visible lesions.
- Potential target organs: Any remaining protocol tissues, which have been examined, have no visible lesions.
- Other observations: Any remaining protocol tissues, which have been examined, have no visible lesions.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- It can be concluded that, according to the results obtained in this study and under the assayed experimental conditions, the test item could be ranked in the Category 4 (LD50 cut-off value of 300 < LD50 < 2000 mg/kg of body weight), of the Globally Harmonised Classification System for Chemical Substances and Mixtures.
- Conclusions:
- The test item could be ranked in the Category 4.
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.