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EC number: 277-040-2 | CAS number: 72927-99-2
- 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
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that the source and the target substance have very similar physicochemical and (eco)toxicological properties because their chemical structures are nearly identical. An analogue approach has thus been employed. The target substance is the meta-isomer of the dye Reactive Blue 049, where the sulphonate group is bound at the meta-position of the aminobenzene moiety. The source chemical is the reaction mass of both the meta-isomer and the para-isomer of Reactive Blue 049.
The presence of sulphonate groups make both dyes highly water soluble and therefore less critical for human health and environmental issues. Based on their chemical similarity, similar properties are expected in both humans and the environment.
2. SOURCE AND TARGET CHEMICAL(S)
Source: Reactive Blue 49 meta/para (CAS# 72214-18-7 / EC# 276-481-8)
Target: Reactive Blue 49 meta (CAS# 72927-99-2 / EC# 277-040-2)
3. ANALOGUE APPROACH JUSTIFICATION
see attachment under 4.2 Melting point / freezing point - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 - < 5 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 in rats lies between 2000 and 5000 mg/kg bw.
- Executive summary:
They key study on acute oral toxicity showed that the source substance did not cause mortality in rats at 2000 mg/kg bw. At 5000 mg/kg bw however, all rats died. Therefore the acute oral LD50 in rats lies between 2000 and 5000 mg/kg bw. In the supporting study, the source substance was tested as a diluted solution. No mortality was observed at 5000 mg/kg bw.
The structurally related target substance will show the same behaviour and therefore it can be anticipated that the acute oral LD50 will be between 2000 and 5000 mg/kg bw as well.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- FAT 41001/C
- Species:
- rat
- Strain:
- other: Tif:RAIf(SPF)
- Sex:
- male/female
- 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: 195-223 g
- Housing: The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Société Parisienne des sciures, Pantin).
- Diet (e.g. ad libitum): Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%):55+-15
- Air changes (per hr):approximately 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours light/day - Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Dose level: 5000 mg/kg bw.
MAXIMUM DOSE VOLUME APPLIED:
10 mL/kg bw - Doses:
- 5000 mg/kg bw.
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily and on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, signs and symptoms, body weight, necropsies - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944) - Preliminary study:
- None
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Non toxic
- Mortality:
- No mortality occured
- Clinical signs:
- other: Dyspnoea, ruffled fur and curved body position were seen being common symptoms in acute tests. In addition a transient diarrhea was observed. All animals recovered within 9 days.
- Gross pathology:
- No gross lesions were found at necropsy.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 value in rats via oral administration of test substance was found to be greater than 5000 mg/kg bw.
- Executive summary:
Upon an acute oral administration and a 14 day post-treatment observation period, the following LD50 was determined:
LD50 in rats of both sexes: >5000 mg/kg bw
According to the company standard the test substance has practically no acute toxicity when administered orally to the albino rat.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- FAT 41001/D
- Species:
- rat
- Strain:
- other: Tif:RAIf(SPF)
- Sex:
- male/female
- 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: 178-219 g
- Housing: The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Société Parisienne des sciures, Pantin).
- Diet (e.g. ad libitum): Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%):55+-15
- Air changes (per hr):approximately 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours light/day - Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 250 and 200 mg/mL
- Amount of vehicle (if gavage): 20 and 10 mL/kg bw
- Dose levels: 5000, 2000 mg/kg bw.
MAXIMUM DOSE VOLUME APPLIED:
20 mL/kg bw - Doses:
- 5000, 2000 mg/kg bw.
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of clinical observations: daily
- Frequency of weighing: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, signs and symptoms, body weight, necropsies - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944) - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 - < 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured at 2000 mg/kg bw, besides one male rat, which died due to intratracheal intubation.
At 5000 mg/kg bw all male and 3 female rats died on Day1. The remaining two female rats died on Day 2. - Clinical signs:
- other: Dyspnoea, exophthalmus, ruffled fur and curved body position were seen, being common symptoms in acute tests. In addition, diarrhea was noted during the first two days as well as a blue staining of the eyes and extremities. The surviving animals recovere
- Gross pathology:
- In the high dose group all animals had a blue stained carcass. No other findings were made at necropsy.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 value in rats via oral administration of test substance was found to lie between 2000 and 5000 mg/kg bw.
- Executive summary:
Upon an acute oral administration and a 14 day post-treatment observation period, the following LD50 was determined :
LD50 in rats of both sexes is between 2000 and 5000 mg/kg bw
According to the company standard the test substance has a slight acute toxicity when administered orally to the albino rat.
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
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The following information is available on the source substance:
A key study was conducted to assess the acute oral toxicity of Reactive Blue 49 (purity: 78.8%) in Wistar rats according to OECD Guideline 401 and EU Method B.1.
Groups of 10 fasted animals (5/sex/dose) received a single oral (gavage) dose of 5000 or 2000 mg/kg bw of the test substance. Parameters assessed included mortality, clinical observations, body weight and necropsy findings in all animals after a 15 d observation period.
At 5000 mg/kg bw all rats died within the first two study days. No test substance-related mortality occurred at 2000 mg/kg bw. No significant macroscopic abnormalities were seen at necropsy. Under the study conditions, the oral LD50 of the test substance was found to be > 2000 and < 5000 mg/kg bw in rats.
In another acute toxicity study with a liquid preparation of Reactive Blue 49 (purity: 26.1 % AS.) the acute oral toxicity of the test substance in rats (oral LD50) was > 5000 mg/kg bw.
Based on the data of all these studies it can be concluded that Reactive Blue 49 has a low toxicity by oral route.
The structurally related target substance will
have a similar low oral toxicity.
Justification for classification or non-classification
Based on the above assessment of the acute oral toxicity, the substance does not need to be classified for acute oral toxicity according to CLP (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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