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EC number: 274-700-1 | CAS number: 70616-89-6
- 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
Endpoint summary
Administrative data
Description of key information
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:
- supporting study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study report contains the limited information on the test conditions because the study has been performed in 1976. However available information is sufficient to conclude on the classification of the substance. Further the test was performed on the vertebrates and use of results from old experimental studies is one of the options to provide information requested by REACH. New experimental studies with vertebrates must only be conducted if there is no adequate existing information.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Weight at study initiation: 110 - 145 g
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- 7.943, 10.00 and 12.59 g/kg
- No. of animals per sex per dose:
- 10 animals
- Control animals:
- no
- Details on study design:
- - Necropsy of survivors performed: yes
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 9 999 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 9 397 - < 10 640
- Mortality:
- 7.943 g/kg: 0 : 1010.00 g/kg: 5 : 1012.59 g/kg: 10 : 10
- Gross pathology:
- organs stained with the test substance
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance, Reactive Orange 13, is not classified as acute toxic by oral exposure according to conditions listed in Regulation (EC) 1272/2008 (CLP).
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- None
- Species:
- rat
- Strain:
- other: Tif:RAIf(SPF)
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland- Age at study initiation: 7-8 weeks- Weight at study initiation: 160-215 g- Housing: Macrolon cages type 4- Diet (e.g. ad libitum): Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland),- Water (e.g. ad libitum): water ad libitum ENVIRONMENTAL CONDITIONS - Temperature (°C): 22+3° C - Humidity (%): 55±15% - Air changes (per hr): 15 air changes/h - Photoperiod (hrs dark / hrs light): 12 hours light/day
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- None
- Doses:
- 2000, 5000 mg/kg bw.
- No. of animals per sex per dose:
- 5 males and 5 females per dose level
- Control animals:
- not specified
- Details on study design:
- None
- Statistics:
- None
- Preliminary study:
- None
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed with the dose of 2000 mg/kg bw, however 1 male out of 5 and 3 females out of 5 were found dead on Day 1 with the dose of 5000 mg/kg bw.
- Clinical signs:
- other: Dyspnoea, exophthalmos, ruffled fur and curved body position were seen, being common symptoms in acute tests. In addition, sedation and diarrhea was observed.
- Gross pathology:
- None
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of compound FAT 40170/B in rats is greater than 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of FAT 40170 was evaluated in a limit test using rats. 5 males and 5 females were administered a single dose of 2000 and 5000 mg/kg bw orally. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, animals were killed by exsanguination under ether anaesthesia and an autopsy performed. No mortality was observed with the dose of 2000 mg/kg bw, however 1 male out of 5 and 3 females out of 5 were found dead on Day 1 with the dose of 5000 mg/kg bw. Dyspnoea, exophthalmos, ruffled fur and curved body position were seen, being common symptoms in acute tests. In addition, sedation and diarrhoea was observed. At autopsy no changes caused by the administration of FAT 40170/B were seen.In conclusion, the acute oral LD50 of FAT 40170 in rats of both sexes observed over a period of 14 days is greater than 2000 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- None
- Species:
- rat
- Strain:
- other: Tif:RAIf(SPF)
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland- Age at study initiation: 7-8 weeks- Weight at study initiation: 174-219 g - Housing: Macrolon cages type 4- Diet (e.g. ad libitum): Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland)- Water (e.g. ad libitum): water ad libitum ENVIRONMENTAL CONDITIONS - Temperature (°C): 22+3° C - Humidity (%): 55+15% - Air changes (per hr): 15 air changes/h - Photoperiod (hrs dark / hrs light): 12 hours light/day
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- None
- Doses:
- 5000 mg/kg bw.
- No. of animals per sex per dose:
- 5 males and 5 females per dose level
- Control animals:
- not specified
- Details on study design:
- None
- Statistics:
- None
- Preliminary study:
- None
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Dyspnoea, exophthalmus, ruffled fur and curved body position were seen, being symptoms frequently observed in acute tests. In addition, a transient sedation was noted.
- Gross pathology:
- None
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of compound FAT 40170/A in rats is greater than 5000 mg/kg bw.
- Executive summary:
The acute oral toxicity of FAT 40170 was evaluated in a limit test usingrats. 5 males and 5 females were administered a single dose of 5000 mg/kg bw orally. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, animals were killed by exsanguination under ether anaesthesia and an autopsy performed. No mortality was observed. Dyspnoea, exophthalmus, ruffled fur and curved body position were seen, being symptoms frequently observed in acute tests. In addition, a transient sedation was noted. In conclusion, the acute oral LD50 of FAT 40170/A in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw.
Referenceopen allclose all
None
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- year 1981
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: breeding farm Velaz Praha- Females (if applicable) nulliparous and non-pregnant: yes- Age at study initiation: 8 weeks- Weight at study initiation: 177.2 g (male, average), 173.2 (female, average)- Diet (e.g. ad libitum): granulated feed mixture ALTROMIN 1320 12 g/animal/day- Water (e.g. ad libitum): tap waster ad libitum- Acclimation period: 1 week ENVIRONMENTAL CONDITIONS - Temperature: 22 ± 3°C - Humidity: 40 - 60 % - Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- head only
- Vehicle:
- air
- Remark on MMAD/GSD:
- Particle size distribution:1 - 4 µm: 76.29 %4 - 10 µm: 17.29 %10 - 20 µm: 5.20 %above 20 µm: 1.21 %
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION - Method of holding animals in test chamber: head only - Source and rate of air: 10 l/min - System of generating particulates/aerosols: Vright Dust Feed Unit MK2, GA 4170, L. Adams ltd., London - Temperature, humidity, pressure in air chamber: temperature 22°C, humidity 55 %, negative pressure 98 Pa TEST ATMOSPHERE - Brief description of analytical method used: Samples of the atmosphere from the inhalation chamber were collected at a rate 4 l/min; 10 liters of air was taken in total. The collected air passed through the filter cartridge and the concentration of the test substance was determined gravimetrically. VEHICLE - Vehicle: air - Concentration of test material in vehicle (if applicable): 4.97 mg/l
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 4.97 mg/l
- No. of animals per sex per dose:
- 5 males / 5 females
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days - Frequency of observations and weighing: observation 1 and 2 hours after ending of the exposure, then once a day; body weight on day 0, 7 and 14 - Necropsy of survivors performed: yes - Other examinations performed: clinical signs, body weight, organ weights
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- not observed
- Clinical signs:
- other: During exposure: orange discharge from the nasal cavity, motor disorders of the body, limbs or tail have not been observedPost exposure period:- 0, 60 and 120 min: piloerection, orange discharge from the nasal cavity, regular breathing 110 - 120 per minut
- Body weight:
- Average body weight: Treated group:- day 0: 177.2 g (M), 173.2 g (F)- day 7: 181.6 g (M), 175.2 g (F)- day 14: 186.8 g (M), 186.8 g (F) Control group:- day 0: 172.7 g (M), 166.7 g (F)- day 7: 173.3 g (M), 198.0 g (F)- day 14: 188.3 g (M), 208.6 g (F)
- Gross pathology:
- Pathological examination did not reveal any general or focal pathology changes.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- For Reactive Orange 13, a limit test for acute inhalation toxicity was performed. The test was performed according to the OECD TG 403 methodology. The experimental animals (rats) were exposed to inhalation of the test substance powder in air for 4 hours in a “head-only” inhalation chamber. Actual concentrations of the test substance were determined gravimetrically. Prior to exposure, the particle size was measured microscopically; majority size was in the range of 1-4 μm.During the exposure and during the 14-day observation period there was no death of the test animals.Clinical disorders of the health of the test animals may be considered as a consequence of mechanical irritation of the upper respiratory tract.The results of the limit test did not reveal any adverse effect on the health of the experimental animals.
- Executive summary:
For Reactive Orange 13, a limit test for acute inhalation toxicity was performed. The test was performed according to the OECD TG 403 methodology. The experimental animals (rats) were exposed to inhalation of the test substance powder in air for 4 hours in a “head-only” inhalation chamber. Actual concentrations of the test substance were determined gravimetrically. Prior to exposure, the particle size was measured microscopically; majority size was in the range of 1-4 μm.
During the exposure and during the 14-day observation period there was no death of the test animals.
Clinical disorders of the health of the test animals may be considered as a consequence of mechanical irritation of the upper respiratory tract.
Pathological examination revealed the penetration of the test substance into the lung tissue in two males. Mild pulmonary congestion probably was caused due to circulation changes in the euthanasia of animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 000 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study report contains the limited information on the test conditions because the study has been performed in 1991. However available information is sufficient to conclude on the classification of the substance. Further the test was performed on the vertebrates and use of results from old experimental studies is one of the options to provide information requested by REACH. New experimental studies with vertebrates must only be conducted if there is no adequate existing information.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Weight at study initiation: 276 - 294 g
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE - Area of exposure: 4 × 6 cm - Type of wrap if used: gauze, aluminum foil, plaster bandage REMOVAL OF TEST SUBSTANCE - Washing (if done): - Time after start of exposure: TEST MATERIAL - Amount(s) applied (volume or weight with unit): 5 g/kg - For solids, paste formed: yes VEHICLE - Amount(s) applied (volume or weight with unit): 1.5 mL water
- Duration of exposure:
- 24 h
- Doses:
- 5 g/kg
- No. of animals per sex per dose:
- 5 animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days - Necropsy of survivors performed: yes - Other examinations performed: clinical signs, body weight, gross pathology
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no animal died
- Clinical signs:
- other: no clinical signs of intoxication
- Gross pathology:
- no pathomorphological changes were observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance, Reactive Orange 13, is not classified as acute toxic by dermal exposure according to conditions listed in Regulation (EC) 1272/2008 (CLP).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
Justification for classification or non-classification
No adverse effect found out in oral, dermal or inhalation exposure route. Reactive Orange 13 does not meet the criteria for classification according to Regulation (EC) No. 1272/2008.
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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