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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Reaction mass of copper complex of [(2,6-difluoroheterocycl-4-yl)amino]hydroxy{[2-hydroxy-3-sulfonato-5-(vinylsulfonyl)phenyl]diazenyl}naphthalene sulfonic acid, dialkali salt and copper complex of [(2,6-difluoroheterocycl-4-yl)amino]-hydroxy{[2-hydroxy-3-sulfonato-5-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl]diazenyl}naphthalene sulfonic acid, trialkali salt
EC number: 479-550-2 | CAS number: -
- 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
The available data for test substance indicates a low potential for acute oral (LD50 >2,000 mg/kg bw) and dermal toxicity (LD50 >2,000 mg/kg bw).
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:
- 2003-Feb-18 to 2003-Mar-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted in accordance with OECD 423 Acute oral toxicity under GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstr. 27, D-33178 Borchen
- Age at study initiation: 6-10 weeks
- Weight at study initiation: 180 ± 6.8 g
- Housing: MacroIon cages (type 4) on soft wood granulate in groups of 3 animals per cage
- Diet (e.g. ad libitum): ssnif R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): Tap water in plastic bottles, ad libitum
- Acclimation period: At least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE:
- concentration in vehicle: 20% suspension
- Amount of vehicle (if gavage): 10 mL/kg body weight - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends
and public holidays only once. The animals were weighed weekly.
- Necropsy of survivors performed: yes - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Female: 2000 mg/kg body weight; Number of animals: 6; Number of deaths: 0
- Clinical signs:
- 10-30 minutes after administration: stilted and uncoordinated gait, squatting posture, irregular respiration, diarrhea and feces, anal region and tray bedding were discolored (reddish).
From day 4 until end of the study no symptoms were observed. - Body weight:
- Development of body weight was not impaired
- Gross pathology:
- No gross pathology changes
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median LD50 of Reactive Red F00-0124 for female HSD Sprague Dawley rats is >2000mg/kg body weight.
- Executive summary:
In an acute oral toxicity study, a group of 6 female Hsd:Sprague Dawley Rats aged 6-10 weeks, were given a single oral dose of Reactive Red F00-0124 in deionized water at a dose of 2000 mg/kg body weight and observed for 14 days.
Oral LD50
Female = >2000 mg/body weight
Reactive Red F00-0124 is of Low toxicity based on the LD50 in female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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:
- 2002-Nov-05 to 2002-Dec-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstrasse 27, D-33178 Borchen
- Age at study initiation: 6-10 weeks
- Weight at study initiation: M=257g; F=207g
- Housing: transparent macrolon cages (type III) on soft wood granulate in an air-conditioned room, 1 animal per cage
- Diet (e.g. ad libitum): ssnif R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50± 20%
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 30 cm²
- Type of wrap if used: the test substance was moistened on a two-ply gauze and an aluminum foil (6 x 8 ern) and distributed as uniformly as possible. The foil was held in place with an elastic plaster bandage fixed around the animal's body.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with warm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g Reaktiv Rot F00-0124 was moistened with 0.4 mL deionized water
- Constant volume or concentration used: yes - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5/sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly.
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2000 mg/kg body weight; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg body weight; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- No symptoms were observed after administration of 2000 mg/kg body weight.
- Body weight:
- 1 female animal showed a slight loss of body weight during the first week of the study, which returned to normal until the end of the study.
In all other animals development of body weight was not impaired. - Gross pathology:
- No gross patholgoy changes
- Other findings:
- The skin of the animals showed violett discolorations from day 2 up to day 6 of the study.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median LD50 of Reactive Red F00-0124 for male and female Sprague Dawley rats is > 2000 mg/kg body weight.
- Executive summary:
In an acute dermal toxicity study, groups of Hsd Sprague Dawley rats, 5/sex, were dermally exposed to Reactive Red F00-0124 in deionized water for 24 hours to 30 cm2 of body surface area at a dose of 2000 mg/kg body weight. Animals then were observed for 14 days.
Dermal LD50:
Males = >2000 mg/kg body weight
Females = >2000 mg/kg body weight
Combined = >2000 mg/kg body weight
Reactive Red F00-0124 is of low Toxicity based on LD50 is >2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Two acute oral toxicity tests in Sprague-Dawley CD rats according to OECD guideline 423 in compliance with GLP were conducted. Animals were observed over 14 days and subjected to gross pathological examination. In one test (test 1), 6 fasted rats were given a single oral dose at a dose level of 2000 mg/kg and a further 6 animals were given a dose of 300 mg/kg. In test 2, 6 fasted rats were given a single oral dose of 2000 mg/kg. In test 1, two mortalities occurred during the study, both in the 2000 mg/kg dosage groups, which was related to an gavage error. Hence, the study was considered to be not reliable and therefore was disregarded. One occurred 2-4 hours after application and the other on day 2 of the study. Clinical signs were observed in the 2000 mg/kg. No clinical signs were observed in the 300 mg/kg group. No changes to body weight occurred for the animals killed at the end of the exposure. Macroscopic changes were observed in the two animals that died during the exposure, including to the lungs, stomach and intestines (plus additional changes in the kidneys, stomach and intestinal tract in animal Number 6 that died on day 2). No macroscopic changes were observed in the animals killed at the end of the exposure. In test 2, no deaths occurred, clinical signs were observed up to day 4 and then not observed for the remaining duration of the test. No pathological signs were recorded at the end of the test. In test 1, the test compound was classified as Class 4 of the global harmonised classification system with an LD50 of between 300 and 2000 mg/kg body weight because of a high lethality rate (2 of 3 animals in one group of the 2000 mg/kg dosage groups). However, discoloration of the lung in the dead animals indicate an application failure (aspiration during gavage). Together with the mean lethality rate in both the 2000 mg/kg groups of 33.3% and a lack of severe symptoms in the surviving animals the LD50 is considered to be above 2000 mg/kg. In test 2, the LD50 was calculated to >2000 mg/kg.
In an acute dermal toxicity study, groups of 5 Hsd:Sprague Dawley rats per sex were given a single dose of Reactive Red F00-0124 formulated in deionized water at a dose of 2000 mg/kg body weight. Animals were then observed for 14 days. No mortality of clinical signs were observed after administration; violet discoloration was visible from day 2 to day 6. The dermal LD50 is >2000 mg/kg body weight, therefore Reactive Red F00-0124 is of low dermal toxicity.
Justification for selection of acute toxicity – oral endpoint
An acute oral toxicity study in rats was performed according to OECD guidelines 423 and following GLP.
Justification for selection of acute toxicity – dermal endpoint
GLP guideline study
Justification for classification or non-classification
No adverse effects relevant for classification and labelling have been concluded based on acute oral and dermal toxicity studies, performed according to OECD 423 and 402.
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.