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EC number: 274-407-9 | CAS number: 70210-10-5
- 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 February 8 to March 21, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 92/69/EEC
- Principles of method if other than guideline:
- In accordance with Safepharm Standard Operating Procedures.
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- Disperse Orange 080
- IUPAC Name:
- Disperse Orange 080
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: harlan U.K. Ltd..
-Age at study initiaqtion: 5 - 8 weeks old.
- Weight at study initiation: males 140 - 160 g; females 128 - 154 g.
- Fasting period before study: overnight immediately before dosing and for approximately 2 hours after dosing.
- Housing: in groups up to 5/sex in solid floor polyprpylene cages.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: minimum 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 23 °C.
- Humidity: 38 - 59 %.
- Air changes: 15 per hours.
- Photoperiod: 12 hours dark and 12 hours light.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- Range-finding study: 2000 mg/kg.
Main test: 500, 1000, 2000 mg/kg (females) and 1000 mg/kg (males). - No. of animals per sex per dose:
- Range-finding study: 1 male and 1 female.
Main test: 5/sex/dose. - Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: once daily for death or overt signs of toxicity; on day 0, 7, 14 or at death for weight.
- Necropsy of survivors performed: yes.
- Other examinations performed: mortality data, clinical signs and body weight.
Results and discussion
- Preliminary study:
- One female animal was found dead one day after dosing. Common signs of systemic toxicity were ataxia, hunched posture, lethargy, pilo-erection, decreased respiratory rate, laboured respiration, red/brown stains around the mouth and snout and splayed gait with isolated incidents of increased lacrimation and ptosis.
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 414 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: purity ca. 45 %
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 636.3 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- All females treated with 2000 mg/kg were found dead one day after dosing.
- Clinical signs:
- No clinical signs of systemic toxicity were noted.
- Body weight:
- Surviving animals showed gain in bodyweight.
- Other findings:
- Abnormalities noted at necropsy of females treated with 2000 mg/kg and dead during the study were haemorrhagic lungs, dark liver, dark kidneys, haemorrhage of the non-glandular epithelium of the stomach and haemorrhage of the small and large intestines. No abnormalities were noted at necropsy of animals treated with 500 or 1000 mg/kg, killed at the end of the study.
Applicant's summary and conclusion
- Interpretation of results:
- other: category 4 according to the CLP Regulation (EC 1272/2008).
- Conclusions:
- The LD50 of the the test material in rats was calculated to be 1414 (1000 - 2000) mg/kg bw by for females only. No difference in toxicity was noted between male and female animals. Male animals were considered not to be markedly more sensitive to the test material than female animals.
- Executive summary:
Method
Single dose study in rats by oral gavage at doses of 1000 mg/kg (males) and 500, 1000, 2000 mg/kg (females) . Animals were observed for 14 days after dosing.
Results
Mortality occurred at dose of 2000 mg/kg, where 5/5 female rats were found dead. No mortality occurred at lower doses (1000 and 500 mg/kg) in both sexes. At post mortem necropsy no abnormalities were seen at doses of 500 and 1000 mg/kg. In females exposed to a dose of 2000 mg/kg, macroscopic observations at necropsy were: haemorrhagic lungs, dark liver and kidneys, haemorrhagic gastric mucosa, slight haemorrhagic non-glandular epithelium of stomach, haemorrhagic small and large intestines.
Based on females only, the LD50 value is 1414 mg/kg, equivalent to 636.3 mg active ingredient/kg bw, with test material purity of 45 %. No difference in toxicity was noted between male and female animals.
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