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EC number: 205-009-5 | CAS number: 131-08-8
- 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
Endpoint summary
Administrative data
Description of key information
In a valid oral toxicity study a dose of 2000 mg/kg bw of Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) was tolerated without symptoms. None of the animals died. The LD50 was greater than 2000 mg/kg bw.
No studies for acute inhalation and dermal toxicity are available.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Five male and five female Wistar rats received a single dose of Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) per gavage. The animals were observed for mortality, clinical signs, weight gain for 14 days. A gross pathological examination of after sacrifice at the end of the study was performed.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals species: Rat / wistar / Dr. Thomae
Animal breeder: Dr. Thomae GmbH
Acclimatisation: At least 1 week
No. animals per dose: 5 male animals and 5 female animals
Type of cage: Stainless steel wire mesh cages, Type DK III
No. animals per cage: 5
Room temperature/ The animals were housed in fully air-conditioned rooms (20 - 24°C; relative humidity 30 - 70°C).
relative humidity
Day/night rhythm: 12 hours / 12 hours
Drinking water: Tap water ad libitum
Diet: Kliba Labordiaet 343
Animals weight: Animals of comparable weight (+/- 20% of the mean weight). - Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% aqueous carboxymethyl cellulose
- Details on oral exposure:
- The animals were given no feed 16 hours before administration, but water was available ad libitum.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female animals per dose
- Control animals:
- no
- Details on study design:
- Signs and symptoms are recorded several times on the day of administration, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.
Withdrawal of food 16 hours before sacrifice; then necropsy with gross-pathological examination. Necropsy of all animals that die as early as possible. - Key result
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 2 000 mg/kg bw
- Remarks on result:
- other: None of the animals died up to the end of the study
- Mortality:
- None
- Clinical signs:
- None
- Body weight:
- Males:
Begin of the test: 191 g
After 7 days: 262 g
After 13 days: 297 g
Females:
Begin of the test: 182 g
After 7 days: 211 g
After 13 days: 226 g - Gross pathology:
- No abnormalities detected.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A dose of 2000 mg/kg bw of Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) was tolerated without symptoms. None of the animals died.
The LD50 is greater than 2000 mg/kg bw. - Executive summary:
Five male and five female Wistar rats received a single dose of Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) per gavage. the animals were observed for mortality, clinical signs, weight gain for 14 days. A gross pathological examination of after sacrifice at the end of the study was performed. None of the animals died during the observation period. No clinical signs and no abnormalities were detected. therefore the LD50 is greater than 2000 mg/kg bw (discriminating dose).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Scientifically acceptable and suffient documented.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a valid oral toxicity study a dose of 2000 mg/kg bw of Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) was tolerated without symptoms. None of the animals died. The LD50 was greater than 2000 mg/kg bw.
According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure’. The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.
Justification for classification or non-classification
In the valid oral toxicity study the LD50 was greater than 2000 mg/kg bw (discriminating dose).
According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure’. The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification for acute toxicity is therefore not justified.
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.
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