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EC number: 279-365-5 | CAS number: 80010-51-1
- 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
Acid Blue 225 is found to have low acute toxicity with oral LD50 >6000 mg/kg bw.
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:
- 14 March 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:
- no
- Specific details on test material used for the study:
- Name: 21036 / A
Purity: 79.9 % - Species:
- rat
- Strain:
- other: Tif. RAI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The compound was tested on 40 Tif. .RAI rats (20 males/20 females), bred under SPF conditions in our own breeding unit. They were 6 to 7 weeks old and weighed 160 to 180 g. The males and females were segregated and housed in Macrolon cages (Type 3) in groups of 5 in a room kept at a constant temperature of 22 ± 1 °C and a relative humidity of approximately 50 %. They received water and food (NAFAG, Gossau SG, rat food) ad libitum. The rats were starved during one night before starting the treatment.
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Doses:
- 1000, 3170, 4640 and 6000 mg/kg
- No. of animals per sex per dose:
- 5 male and 5 females
- Control animals:
- no
- Details on study design:
- FAT 21036/A was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 10 and 30 % with carboxymethylcellulose 2 % and administered by oral intubation. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 6 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One animal was found dead in 6000 mg/kg group.
- Clinical signs:
- other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 4 to 6 days
- Gross pathology:
- No substance related gross organ changes were seen.
- Other findings:
- No further abnormalities reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 of FAT 21036/A in rats of both sexes observed over a period of 7 days is greater than 6000 mg/kg.
- Executive summary:
The acute oral toxicity of FAT 21036/A was assessed using Tif. RAI rats in a study conducted using methodology similar to OECD Guideline 401. FAT 21036/A was suspended at 30 % with polyethylene glycol (PEG 400). The test material was administered at different doses (5 males and 5 females rats per dose): 1000, 3170, 4640 and 6000 mg/kg. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 4 to 6 days. No substance related gross organ changes were seen at the post mortem examination. In conclusion, the acute oral LD50 of FAT 21036/A in rats of both sexes observed over a period of 7 days is greater than 6000 mg/kg. The compound therefore is non-toxic to the rat by this route of administration.
Reference
Mortality:
Dose mg/kg |
Concentration % of formulation |
No of Animals | Died within |
||||||||||
m | f | m 2hr | f 1hr | m 24 hrs | f24 hrs | m 48 hrs | f 48 hrs | m 7 d | f 7 d | m 14 d | f 14 d | ||
1000 | 10 | 5 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3170 | 30 | 5 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
4640 |
30 |
5 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
6000 |
30 |
5 |
5 |
0 |
1 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
No higher dosed were possible |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 6 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity: oral
The acute oral toxicity of FAT 21036/A was assessed using Tif. RAI rats in a study conducted using methodology similar to OECD Guideline 401. FAT 21036/A was suspended at 30 % with polyethylene glycol (PEG 400). The test material was administered at different doses (5 males and 5 females rats per dose): 1000, 3170, 4640 and 6000 mg/kg. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 4 to 6 days. No substance related gross organ changes were seen at the post mortem examination. In conclusion, the acute oral LD50 of FAT 21036/A in rats of both sexes observed over a period of 7 days is greater than 6000 mg/kg. The compound therefore is non-toxic to the rat by this route of administration.
Acute toxicity: inhalation
Currently no study to assess the acute inhalation toxicity potential of Acid Blue 225 is available. However, the vapour pressure for the substance can be considered low owing to the high melting point (>300 °C). Hence, the substance is considered to have low volatility. Synthesis and formulation of this chemical is performed in a closed process; the final product consists of liquid formulations only. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets. Referring to the expected low volatility of the substance, the fact that the substance is imported into the EU in a formulated form as liquid formulation, the exposure via inhalation is considered to be unlikely. Further, in case the substance enters the respiratory tract, it will be trapped in the mucus and cleared owing to its high water solubility of 64.3 g/L, thereby further limiting the absorption. The chemical showed low toxicity potential in the available acute oral toxicity study (LD50 >6000 mg/kg bw) with no mortality or systemic toxicity up to 2000 mg/kg bw, hence it does not need to be classified STOT SE. Taking the above arguments into account, low toxicity potential is expected on acute exposure of Acid Blue 225 via inhalation route and hence testing by the inhalation route was considered scientifically not necessary.
Acute toxicity: dermal
Currently no study to assess the acute dermal toxicity potential of Acid Blue 225 is available. However, the molecular weight of Acid Blue 225 is 669.5 g/mol, indicating it being too large for dermal absorption.It has water solubility of 64.3 g/L and n-octanol/water partition coefficient (log P) of 0.58, indicating it being too hydrophilic to cross the lipid rich environment of the stratum corneum. Hence, the dermal uptake for the substance will be low.The chemical showed low toxicity potential in the available acute oral toxicity study (LD50>6000 mg/kg bw), with no mortality or systemic toxicity being seen up to 2000 mg/kg bw, hence it does not need to be classified as STOT SE. Similarly, absence of systemic toxicity in skin irritation and sensitisation studies further supports the conclusion that no adverse effects are expected for the chemical via the dermal route. Further, experience with similar chemical substances has demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the chemical only show up upon dermal exposure and not after systemic application. Taking above arguments into account, low toxicity is expected on acute dermal exposure of Acid Blue 225 and testing by the dermal route was considered scientifically not necessary.
Justification for classification or non-classification
Acid Blue 225 is found to have low acute toxicity with oral LD50 >6000 mg/kg bw, hence it does not meet the criteria of classification for acute toxicty and/or specific target organ toxicity on single exposure according to the 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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