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EC number: 291-103-1 | CAS number: 90341-71-2
- 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
Substance is practically not toxic
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:
- June 22,1983 to July 06,1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant with international guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- 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: 8 - 10 weeks
- Weight at study initiation: male 179 g , female 187 g
- Housing: 5 rats/cage in Macrolon cages type IV
- Fasting period before study: 16 hrs before the treatment and 2 hrs after
- Diet : Rattendiät Altromin 1324 , ad libitum
- Water : ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%):55 ± 10 %
- Photoperiod : 12 hrs cycle dark/light - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- demineralized
- Details on oral exposure:
- Concentration 25% (w/v) in water
Dose: 5000 mg/kg bw
Apllication volume: 20 mL/kg bw - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: yes , once a week
- Frequency of clinical observations: multiple times on Day 1, twice daily thereafter
- Necropsy of survivors performed: yes - Statistics:
- NA
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mL/kg bw
- Based on:
- test mat.
- Mortality:
- One female died within 3 hours after dosing. As the lung was bluish discolored, it may be that part of the test substance was aspirated during gavage.
- Clinical signs:
- other: Day 1: Males + females: Reduced activity, pale skin; from 2 hours onwards bluish discolored skin; bluish discolored feces on Day 1 and 2 Females: From 2 hours until end of Day 1 hunched posture; one animal showed narrowed eyelids
- Gross pathology:
- death female: blue liquid in GIT; lung patrially bluish discolored; skin light bluish discolored
One male: lung reddish discolored
All other rats were without abnormal findings - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance Remazol Brilliantblau is considered non toxic by oral administration.
- Executive summary:
Remazol Brilliant Blue BB has been tested in male and female Wistar rats at a limit dose of 5000 mg/kg bw. The results shows a medium lethal dose (LD50) of above 5000 mg/kg body weight in male and female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 15 February 1995 to 01 March 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to recent EU and OECD test guidance in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- 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: Harlan Winklemann GmbH
- Age at study initiation: Males 8 - 10 weeks, Females 12 - 14 weeks
- Weight at study initiation: Inital mean weight: Males - 224g, Females - 199g
- Fasting period before study: No data
- Housing: Conventional conditions, Makrolon Type-II cages, invidually
- Diet (e.g. ad libitum): Altronim 1324 pellets, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10 - 15 per hours
- Photoperiod (hrs dark / hrs light): 12 hours light/dark (artifical light from 6am to 6 pm) - Type of coverage:
- occlusive
- Vehicle:
- castor oil
- Remarks:
- polyethoxylated (Cremophor EL)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back & flanks
- % coverage: 10
- Type of wrap if used: non-irritant skin plaster (Fermoflexband)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Luke warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): No data - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- Males - 5
Females - 5 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: Several times on the day of application then twice daily (once at weekends & bank holidays). Weighing: Directly before administration, after one week and at the end of the 14 day observation period.
- Necropsy of survivors performed: yes - Statistics:
- Taking into consideration available data, the dosages are selected in such a way that graded lethality rates are obtained, which allow calculation or at least an estimate of the LD50.
Sufficient characterisation of acute dermal toxicity is reached as a rule, even if no substance-related lethality occurs at a dosage of 2000 mg/kg body weight.
The dosages are given in mg/kg body weight.
The following dosage was administered:
2000 mg/kg body weight
The calculation of the amount of test substance to be administrated was done taking into account a content of 65%.
Calculation of the Median Lethal Dose (LD50)
If calculation of the median lethal dose (LD50) is possible, it is done according to Spearman-Karher. The algorithm was adopted from SACHS, L. (Angewandte Statistik, 6.Auf1. 1984 , 178).
Should there be value pairs with a mortality of 0% and 100%, the geometric mean of the corresponding dosages is regarded as the "approximate LD50 value".
If only one dose group is used, the LD50 is estimated. - Preliminary study:
- Not applicable.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died during the 14-day observation period.
- Clinical signs:
- other: No signs of systemic poisoning were observed after single application of 2000 mg/kg body weight. After the 21-hour exposure the skin in the area of the application site showed a blue discoloration in all rats. This coloration persisted until the 9th day
- Gross pathology:
- None of the animals sacrificed at the end of the 14-day observation period showed any noticeable gross pathological findings.
- Other findings:
- None
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the present investigations, the test substance is therefore to be regarded as relatively non-toxic after acute dermal exposure.
LD50 > 2000 mg/kg body weight - Executive summary:
Study conducted to recent EU test guidance 92/69/EEC part B3 and OECD test guideline 402 in compliance with GLP.
Based on the study the test substance is to be regarded as relatively non-toxic after acute dermal exposure. The test substance is not classified.
LD50 > 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Reactive Blue 220 has been tested in male and female Wistar rats at a limit dose of 5000 mg/kg bw. The results shows a medium lethal dose (LD50) of above 5000 mg/kg body weight in male and female rats.
A structural analogue of Reactive Blue 220 has been tested at a limit dose of 2000 mg/kg bw for dermal toxicity and did not show any adverse effects at this dose level.
Justification for classification or non-classification
No adverse effects or mortality has been observed at limit doses of 5000 and 2000 mg/kg bw in oral or dermal toxicity studies, respectively. Hence the test substance is not classified.
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