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EC number: 219-949-9 | CAS number: 2580-78-1
- 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 oral and dermal LD50 is higher than 2000 mg/kg bw in rats.
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:
- 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:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: NA
- Weight at study initiation: 82 - 108 g (mean: 95 g)
- Fasting period before study: 16 hours prior and 2 hours after gavage
- Housing: in groups
- Diet (e.g. ad libitum): ALTROMlN 1324 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: NA (own breeding) - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- 25 g/mL in deionized water
- Doses:
- 6300, 8000, 10000, 12500 mg/kg bw
- No. of animals per sex per dose:
- 10 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: frequently on day 1, twice daily thereafter
- Frequency of weighing: weekly
- Necropsy of died animals performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Probit analysis according to LINDER and WEBER
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 10 135 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 9 355 - 10 979
- Remarks on result:
- other: p = 0.05
- Mortality:
- 6300 mg/kg: 0/10
8000 mg/kg: 1/10
10000 mg/kg: 3/10
12500 mg/kg:10/10
Deaths occurred between 30 minutes and 12 hours after gavage - Clinical signs:
- other: Died animals showed the following signs prior to death: ataxia, prone position, lateral position Visible skin was bluish discolored in all treated animals After 24 hours: all surviving rats: NAD
- Gross pathology:
- died animals: bluish discolored inner organs
- Other findings:
- The dye was excreted via urine and feces.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50: 10135 mg/kg bw
- Executive summary:
The dye, which is present as a dark blue powder, was administered as an aqueous solution in different doses once by gavage to female SPF Wistar rats of own breeding weighing 82 - 108 g (average weight 95 g). The test was performed in female rats, as sex-related differences could not be determined in preliminary tests. Ten rats were used per dose. The rats were deprived of food 16 hours before application. 2 hours after administration of the dye, the rats were given food again. The observation period after application was 14 days. During this period, in which the animals were weighed weekly, the animals were fed the husbandry diet ALTROMIN 1324 from the company Altrogge in Lage/Lippe and tap water. Feed and water were offered ad libitum. The animals were kept in plastic cages on wood shavings. Lethally poisoned animals were dissected and macroscopically assessed.
The LD50 was determined by means of a probit analysis (method according to LINDER and WEBER); the confidence limits were calculated according to CAVALLI-SFORZA (Dept. of Practical Mathematics of Hoechst Aktiengesellschaft).
Fatally poisoned animals died, after showing ataxia, in prone or lateral position. The hairless parts of the body were coloured blue. The dye was excreted with the faeces and urine. The body weight development of individual animals in the 10000 mg/kg bw group was delayed. The necropsy of the dead animals showed macroscopically a blue colouration of the internal organs.
Acute oral toxicity testing revealed an LD50 of 10135 mg/kg body weight. According to the usual classification based on acute toxicity (W.S. SPECTOR in the "Handbook of Toxicology"), the present dye would be considered practically non-toxic after a single oral administration.
Reference
Dose [mg/kg bw] |
Mortality |
6300 |
0/10 |
8000 |
1/10 |
10000 |
3/10 |
12500 |
10/10 |
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 10 135 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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Se Read Across Justification in section 13
- Reason / purpose for cross-reference:
- read-across source
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: males: ca 7 weeks; females: ca 8 weeks
- Weight at study initiation: mean: males: 178 g; females: 184 g
- Fasting period before study: NA
- Housing: single
- Diet: Altromin 1324 ad libitum
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 25.11.1987 To: 9.12.1987 - Type of coverage:
- occlusive
- Vehicle:
- physiological saline
- Remarks:
- 0.9% NaCl solution in the proportion of 1 g + 1 ml to form a paste
- Details on dermal exposure:
- Area: 30 cm²
- Duration of exposure:
- 24 h
- Doses:
- 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 observations and weighing: body weight: weekly; clinical signsand mortality: frequently first day; twice daily thereafter
- Necropsy of survivors performed: yes - Statistics:
- NA
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: no sytemic clinical signs were observed
- Gross pathology:
- No effects observed
- Other findings:
- Blue or red to purple discolored skin up to 6 days after test substance application
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Acute dermal LD50 male/female is greater than 2000 mg/kg.
- Executive summary:
The acute dermal toxicity test in the Wistar rat was tested at a limit dose of 2000 mg/kg body weight in male and female animals. No deaths occurred after application of 2000 mg/kg bw. No signs of toxicity occurred during the entire test period. The treated skin area was blue or red to purple in colour until day 6 p.a.. The body weight development was not affected.
The necropsy of the animals killed after the end of the experiment did not reveal any macroscopically visible peculiarities.
Based on the acute dermal toxicity test in the male and female Wistar rat, the test substance has a dermal LD50 of above 2000 mg/kg body weight.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 84/449/EWG, B.3; OECD 402
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- 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
- Age at study initiation: males: ca 7 weeks; females: ca 8 weeks
- Weight at study initiation: mean: males: 178 g; females: 184 g
- Fasting period before study: NA
- Housing: single
- Diet: Altromin 1324 ad libitum
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 25.11.1987 To: 9.12.1987 - Type of coverage:
- occlusive
- Vehicle:
- physiological saline
- Remarks:
- 0.9% NaCl solution in the proportion of 1 g + 1 ml to form a paste
- Details on dermal exposure:
- Area: 30 cm²
- Duration of exposure:
- 24 h
- Doses:
- 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 observations and weighing: body weight: weekly; clinical signsand mortality: frequently first day; twice daily thereafter
- Necropsy of survivors performed: yes - Statistics:
- NA
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: no sytemic clinical signs were observed
- Gross pathology:
- No effects observed
- Other findings:
- Blue or red to purple discolored skin up to 6 days after test substance application
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acute dermal LD50 male/female is greater than 2000 mg/kg.
- Executive summary:
Die Prüfung der akuten dermalen Toxizität von Reaktiv Blau F-64 357 FW an der Wistar-Ratte ergab bei männlichen und weiblichen Tieren eine Dosis letalis media (LD50) über 2000 mg/kg Körpergewicht. Nach Applikation von 2000 mg/kg Kgw. traten
keine Todesfälle auf.
Während der gesamten Versuchszeit traten keinerlei Vergiftungssymptome auf. Die behandelte Hautfläche war bis zum 6. Tag p.a. blau bzw. rot bis lila verfärbt.
Die Sektion der nach Versuchsende getöteten Tiere ergab keine makroskopisch sichtbaren Besonderheiten.
Die Körpergewichtsentwicklung war nicht beeinträchtigt.
Aufgrund der akuten dermalen Toxizitätsprüfung an der männlichen und weiblichen Wistar-Ratte ist Reaktiv Blau F-64 357 FW nach den Einstufungskriterien der Richtlinie 83/467/EWG und der Gefahrstoffverordnung nicht kennzeichnungspflichtig.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
The dye, which is present as a dark blue powder, was administered as an aqueous solution in different doses once by gavage to female SPF Wistar rats of own breeding weighing 82 - 108 g (average weight 95 g). The test was performed in female rats, as sex-related differences could not be determined in preliminary tests. Ten rats were used per dose. The rats were deprived of food 16 hours before application. 2 hours after administration of the dye, the rats were given food again. The observation period after application was 14 days. During this period, in which the animals were weighed weekly, the animals were fed the husbandry diet ALTROMIN 1324 from the company Altrogge in Lage/Lippe and tap water. Feed and water were offered ad libitum. The animals were kept in plastic cages on wood shavings. Lethally poisoned animals were dissected and macroscopically assessed.
The LD50 was determined by means of a probit analysis (method according to LINDER and WEBER); the confidence limits were calculated according to CAVALLI-SFORZA (Dept. of Practical Mathematics of Hoechst Aktiengesellschaft).
Fatally poisoned animals died, after showing ataxia, in prone or lateral position. The hairless parts of the body were coloured blue. The dye was excreted with the faeces and urine. The body weight development of individual animals in the 10000 mg/kg bw group was delayed. The necropsy of the dead animals showed macroscopically a blue colouration of the internal organs.
Acute oral toxicity testing revealed an LD50 of 10135 mg/kg body weight. According to the usual classification based on acute toxicity (W.S. SPECTOR in the "Handbook of Toxicology"), the present dye would be considered practically non-toxic after a single oral administration.
The acute dermal toxicity test in the Wistar rat was tested at a limit dose of 2000 mg/kg body weight in male and female animals. No deaths occurred after application of 2000 mg/kg bw. No signs of toxicity occurred during the entire test period. The treated skin area was blue or red to purple in colour until day 6 p.a.. The body weight development was not affected.
The necropsy of the animals killed after the end of the experiment did not reveal any macroscopically visible peculiarities.
Based on the acute dermal toxicity test in the male and female Wistar rat, the test substance has a dermal LD50 of above 2000 mg/kg body weight.
Justification for classification or non-classification
Substance is practically non-toxic; no clasification necessary
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