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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 287-574-8 | CAS number: 85536-87-4
- 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
Reactive Orange 72/78 is practically non-toxic. The LD50 for oral administration is 8377 mg/kg body weight, the LD50 for dermal application withthe structural analogue 01 lies above 2000 mg/kg body weight.
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
- Study period:
- December 20,1973 to January 4,1974
- 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)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 85 g
- Fasting period before study:16 hours before gavage application and 2 hours after
- Housing: in macrolon cages on soft wood granulate
- Diet : Altromin 1324 rat diet, ad libitum
- Water : ad libitum
Start of study: December 20, 1973
End of study: January 04, 1974 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25% - Doses:
- 6300, 8000, 10000, 12500 mg/kg bw
- No. of animals per sex per dose:
- 10 female rats per dose level
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Clinical signs: multiple times on Day 0 and daily for 14 days thereafter
- Body weight: weekly
- Necropsy of survivors performed: yes - Statistics:
- The LD50 and the limits of confidence were established in female animals on the basis of the Iethality rates by probit analysis.
(method of LINDNER and WEBER, and method of CAVALLI-SFORZA, programs supplied by Prakt. Mathematik, Hoechst Aktiengesellschaft) - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 8 377 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 7 741 - 9 065
- Sex:
- female
- Dose descriptor:
- LD100
- Effect level:
- 12 500 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 6 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 8000 mg/kg: 4 of 10 rats
10000 mg/kg: 9 of 10 rats
12500 mg/kg: 10 of 10 rat - Clinical signs:
- other: prone position and disorders of balance
- Gross pathology:
- orange discolouration of organs and connective tissue
- Other findings:
- The dye was in the feces and urine.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results obtained in this study the median lethal dose value (LD50) of Remazol Goldorange 3G was calculated by probit analysis for the female Wistar rat to be 8377 mg/kg body weight.
- Executive summary:
- Remazol Goldorange 3G was tested for acute toxic effects by oral administration in female Wistar rats only, as male animals did not show a higher sensitivity to the test substance. Lethality occurred up to day 3 of the study at 8000, 10000, and 12500 mg/kg bw. The animals showed prone position and disorders of balance. Development of body weight was not impaired in the surviving animals. The test substance was excreted with feces and urine. Necropsy of the deceased animals revealed orange discolouration of organs and connective tissue. The acute oral toxicity testing of Remazol Goldorange 3G in the female Wistar rat yielded a median lethal dose (LD50) of 8377 mg/kg body weight. The classification by “Handbook of Toxicology” describes the test dye as non toxic
Reference
Doses mg/kg |
concentrations in % | Mortality |
6300 | 25 | 0 of 10 rats |
8000 | 25 | 4 of 10 rats |
10000 | 25 | 9 of 10 rats |
12500 | 25 | 10 of 10 rats |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 8 377 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
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:
- July 15,1985 to July 29 ,1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Age at study initiation:male 7 weeks old , females 10 weeks old
- Weight at study initiation:male 184-200 g , female 189-219
- Fasting period before study: NA
- Housing: individually housed in air-conditioned rooms in Makrolon cages (type 3) on softwood pellets
- Diet : altromin 1324, ad libitum
- Water : tap water in plastic bottle, ad libitum
- Acclimation period:5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 ±°C
- Humidity (%):50 ± 20%
- Air changes (per hr):fully air condition
- Photoperiod (hrs dark / hrs light):12 hours cycle dark/light - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure:30 cm^2
- % coverage: 6 x 8 cm
- Type of wrap if used:
aluminum-foil (6 x 8 cm) and one elastic. The elastic is used to fix around the body of the animal the aluminium foil (Elastoplast, 8 cm).
REMOVAL OF TEST SUBSTANCE
- Washing :yes
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):Reactive Orange 64 258 FW F-ratio was 1.0 g + 0.50 ml moistened with isotonic saline solution (sterile, pyrogen-free, supplied by Fresenius AG).
- For solids, paste formed: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals x sex x dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:every weeks
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- other: no clinical signs observed
- Gross pathology:
- no adverse effects
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal medium lethal dose (LD50) was determined to lie above 2000 mg/kg body weight.
- Executive summary:
The test substance was examined for acute dermal toxicity in male and female Wistar rats at the limit dose of 2000 mg/kg body weight. After administration of 2000 mg/kg bw no deaths or clinical signs of toxicity were observed.The dermal medium lethal dose (LD50) was determined to lie above 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
The acute oral toxicity testing of Reactive Orange 72/78 in the female Wistar rat was carried out at dose levels of 6300, 8000, 10000, and 12000 mg/kg body weight. Male animals did not show a higher sensitivity to the test substance. Lethality occurred up to day 3 of the study. The animals showed prone position and disorders of balance. The test substance was excreted with feces and urine. Development of body weight was not impaired. Necropsy of the deceased animals revealed orange discolouration of organs and connective tissue.
Based on the results obtained in this study the median lethal dose value (LD50) of Reactive Orange 72/78 was calculated by probit analysis for the female Wistar rat to be 8377 mg/kg body weight.
The test substance was examined for acute dermal toxicity in male and female Wistar rats at the limit dose of 2000 mg/kg body weight. After administration of 2000 mg/kg bw no deaths or clinical signs of toxicity were observed.The dermal medium lethal dose (LD50) was determined to lie above 2000 mg/kg body weight.
Justification for classification or non-classification
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.