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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 401-270-6 | CAS number: 122390-99-2
- 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
An acute oral and dermal toxicity study were performed according to the EC guideline 84/449, which is similar to the OECD guidelines.
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:
- 1985-Aug-13 to 1985-Aug-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to EC guideline 84/449, which is similar to OECD 401.
- Qualifier:
- according to guideline
- Guideline:
- other: EC Regulation No. 84/449 (L 251, 96)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- 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:
- TEST ANIMALS
- Source: Winkelmann, Borchen, SPF breeding colony
- Age at study initiation: 9 weeks (Male) to 14 weeks (Female)
- Weight at study initiation: Male=176 g; Female 172 g
- Fasting period before study: 16 h
- Housing: macrocolon cages (type III) on wood granulate, in groups of 5 animals per cage
- Diet (e.g. ad libitum): Altromin R 1324, ad libitum (except 16h before to 4h after substance application)
- Water (e.g. ad libitum): Water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 10%
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Animals obtained one single dose of 5000 mg of Reactive Blue FC 15353 per kg bodyweight by gavage using a rigid metal stomach tube. The total application volume was 20 ml per kg of bodyweight.
- Doses:
- 5000 mg Reactive Blue FC 15353 per kg bodyweight, corrseponding to an applied volume of 20 ml/kg of the prepared solution.
- No. of animals per sex per dose:
- 5
- 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; on weekend and public holidays only once. Animal weighing: 1/week
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- Male: 5000 mg/kg body weight; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg body weight; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: No abnormal clinical signs were observed.
- Gross pathology:
- No gross pathology changes
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of Reactive Blue FC 15353 for male and female Wistar rats is >5000 mg/ kg body weight.
- Executive summary:
In an acute oral toxicity study, groups of 16 hours fasted 9 (male) to 14 (female) weeks old Wistar rats, 5/sex were given a single oral dose of Reactive Blue FC 15353 in water by gavage at a dose of 5000 mg/ kg body weight and observed for 14 days.
Oral LD50
Males = >5000 mg/kg body weight
Females = >5000 mg/kg body weight
Combined = >5000 mg/kg body weight
Reactive Blue FC 15353 is of LOW toxicity based on the LD50 > 5000 mg/kg body weight in male and 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:
- from 1985-Aug-20 to 1985-Sep-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to EC guideline 84/449, which is similar to OECD 402.
- Qualifier:
- according to guideline
- Guideline:
- other: EC-directive 84/449 (L251,96)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- 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:
- TEST ANIMALS
- Source: Winkelmann, Borchen, SPF breeding colony
- Age at study initiation: 9 weeks (male) to 14 weeks (female)
- Weight at study initiation: 180 g (male), 184 g (female)
- Housing: macrolon cages (type III) on wood granulate, in groups of 5 animals/cage
- Diet (e.g. ad libitum): Altromin R 1324, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2 °C
- Humidity (%): 50±10 %
- 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 10% skin surface
- Type of wrap if used: aluminum foil and fixed with non-irritating plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 ml/kg body weight
- For solids, paste formed: yes - using water - Duration of exposure:
- 24 h
- Doses:
- 5 ml/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms recorded twice every day (once on weekends and public holidays); animals were weighed weekly
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2500 mg/kg body weight; Number of animals: 5; Number of deaths: 0
Female: 2500 mg/kg body weight; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: No symptoms were observed.
- Gross pathology:
- No gross pathological changes
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median LD50 of Reactive Blue FC 15353 for mals and female Wistar rats is >2500 mg/kg body weight.
- Executive summary:
In an acute dermal toxicity study, Wistar rats, 5/sex, were dermally exposed to Reactive Blue FC 15353 in deionized water for 24 hours to 10 % of body surface area at a dose of 2500 mg/kg body weight. Animals then were observed for 14 days. No mortality or clinical signs were observed after administration.
Dermal LD50:
Males = >2500 mg/kg body weight
Females = >2500 mg/kg body weight
Combined = >2500 mg/kg body weight
Reactive Blue FC 15353 is of LOW Toxicity based on LD50 > 2500 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
In two acute oral and dermal toxicity studies, groups of 5 Wistar rats per sex were given a single dose of Reactive Blue FC 15353 in deionized water at a dose of 5000 mg/kg body weight (oral) or 2500 mg/kg body weight (dermal). Animals were then observed for 14 days. The experiments were limit tests. No mortality or clinical signs were observed after administration.
The oral LD50 is >5000 mg/kg body weight, the dermal LD50 is >2500 mg/kg body weight, therefore, Reactive Blue FC 15353 is of low toxicity.
Justification for selection of acute toxicity – oral endpoint
An acute oral toxicity study was performed according to the EG guideline 84/449, which is similar to the OECD guideline 401.
Justification for selection of acute toxicity – dermal endpoint
An acute dermal toxicity study was performed according to EG regulation No. 84/449 (L251,96)
Justification for classification or non-classification
No adverse effects were observed in an acute oral and dermal toxicity study, performed according to EC guideline 84/449.
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.