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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 269-304-0 | CAS number: 68214-62-0
- 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
Not harmful/toxic if swallowed
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
- Study period:
- From May 26th to August 15th, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The read across approach is detailed into the document attached to the IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TOP Velaz Ltd.
- Weight at study initiation: 150 g
- Housing: 5 rats were housed in separated menagerie of plastic polypropylene cages T4, equipped with dry softwood chip which was sterilized in a hot air sterilizer HS 401 A / 1 at 150 °C for 90 minutes.
- Diet: standard commercially manufactured complete Mixed fodders ST-1, 10 g /animal/ day.
- Water: drinking water according to CSN 757111, ad libitum.
- Acclimation period: one week.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 50 ± 15 %
- Photoperiod: 12 hrs cycle dark /light
- Other: fluorescent light - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 % suspension - Doses:
- 7943, 8913, 10000 and 12590 mg/kg
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: the animals were observed for clinical signs of intoxication immediately after application (after 30 minutes), 3 hours after application and once a day for 14 days.
- Frequency of weighing: the animals were weighed before the oral administration and during the observation period.
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical diagnosis was focused on observation of the appearance of skin, fur, visible mucous membranes, nutritional status, mental activity, somatomotor activity, responses to stimuli, focusing on sensibility and reactivity, lacrimation, assessment function respiratory, digestive, urogenital and circulatory system. Organs and muscles were examined macroscopically. After dissection internal organs were judged according to their color, size, consistency and structure. If the post-mortem bladder is filled with urine, the urine were carried out biochemical tests indicative indicator strips Heptaphan focusing on the detection of proteins, blood sugars, ketones, bilirubin, urobilinogen and pH. - Statistics:
- LD50 is calculated by the probit method according to Bliss. Mortality data used and the frequency and level logarithmic doses were entered into a computer and analyzed by the program PROBIT.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 9 476.1 mg/kg bw
- Based on:
- test mat.
- Remarks:
- (ca 6633.27 a.i. mg/kg bw)
- Mortality:
- Mortality is observed in doses higher than 7943 mg/kg.
- Clinical signs:
- After application of the logarithmic dose of 12590 mg/kg the following clinical symptoms of intoxication were observed:
- appearance of skin and hair: blue coloration of the skin after application and smoot, shiny hair
- nutritional status: good
- appearance of visible mucous membranes: blue color of the lining of the nose and conjunctivitis
- mental activity: within the physiological standards
- somatomotor activity: locomotion disorders due to ataxia
- reactivity and sensibility: hypergie, hyperaesthesia
- functions of the digestive system: diarrhea - Body weight:
- Body weight loss was observed for male and female rats.
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- LD50 (male and female): 9476.1 mg/kg bw (6633.27 mg/kg bw based on the active ingredient)
- Executive summary:
The substance has been tested for acute toxicity by oral route according to OECD guideline 401. 5 male and 5 female Wistar rats per group were tested with the following dose: 0, 7943, 8913, 10000 and 12590 mg/kg.
After 14 days of observation period the rats showed weight loss in all the application doses.
Mortality was observed in doses higher than 7943 mg/kg. After application of the logarithmic dose of 12590 mg/kg the following clinical symptoms of intoxication were observed: coloration of the skin after application and smoot, shiny hair, blue color of the lining of the nose and conjunctivitis, locomotion disorders due to ataxia, hypergie, hyperaesthesia and diarrhea.
Conclusion
LD50 (male and female): 9476.1 mg/kg bw (6633.27 mg/kg bw based on the active ingredient)
Reference
Dose (mg/kg) | Mortality | ||
Male | Female | Total percentage | |
7943 | 0 | 0 | 0 |
8913 | 1 | 2 | 30 |
10000 | 2 | 5 | 70 |
12590 | 5 | 5 | 100 |
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
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
ACUTE ORAL
An old experiment was conducted on the test item; however, due to the fact that details on testing procedures and results are lacking, a reliability cannot be assigned. The result is here mentioned for completeness sake. The substance was orally administered to male rats, by gavage, at volume of 1.5 ml/100 g bw. The LD50 was indicated to be greater than 5000 mg/kg (see attachment).
In order to assess the oral acute potential toxicity of Acid Blue 280, the available information on the structural analogue Similar Substance 03 was taken into consideration; the read across approach can be considered as appropriate and suitable to assess the property under investigation (details about the approach are reported into the IUCLID section 13).
Similar Substance 03 was tested for acute toxicity by oral route, according to OECD guideline 401. Mortality was observed in doses higher than 7943 mg/kg. After application of the logarithmic dose of 12590 mg/kg the following clinical symptoms of intoxication were observed: coloration of the skin after application and smoot, shiny hair, blue color of the lining of the nose and conjunctivitis, locomotion disorders due to ataxia, hypergie, hyperaesthesia and diarrhea. The LD50 (male and female) was indicated to be 9476.1 mg/kg bw (6633.27 mg/kg bw based on the active ingredient).
ACUTE DERMAL
An old experiment was conducted on the test item; however, due to the fact that details on testing procedures and results are lacking, a reliability cannot be assigned. The result is here mentioned for completeness sake. The substance was placed on skin of male rats, over a period of 4 hours. The LD50 was indicated to be greater than 5000 mg/kg (see attachment).
REFERENCE
See attachment
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).
The oral LD50 value was established to be greater than 2000 mg/kg body weight, thus the test substance is expected to be out of any classification limit for acute oral toxicity (oral acute toxicity category 4: 300 < ATE ≤ 2000 mg/kg bw).
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.