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EC number: 285-249-5 | CAS number: 85049-76-9
- 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
Non sensitising to the skin.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No data to assess the skin sensitising potential of Acid Green 104 was available, thus a read-across approach was adopted. In particular, available data on Similar Substance 01 and Similar Substance 02, i.e. cobalt complexes with 2 phenyl-azo-naphtyl ligands functionalised by similar groups, was used. Details on the read across are attached in section 13.
Similar Substance 01 was tested in Local Lymph Node Assay in mice (OECD guideline 429). Concentrations of 1 %, 2 % and 5 % w/w in DMF were used. Upon a pre-experiment, the 5 % concentration was found to be the highest concentration at which non excessive local irritation and no systemic toxicity was noted.
In the main test, no signs of systemic toxicity were noted; erythema could not be evaluated due to the colour of the substance. No statistically significant increase in ear weight (cutoff value of 1.1 in BALB/c mice) was seen.
Stimulation Indices (S.I.) of 1.27, 2.01 and 2.22 were determined at concentrations of 1, 2, and 5% (w/w) in DMF, respectively. A clear dose response was observed, but the threshold value of 3 for positive response was not reached.
A statistically significant but biologically not relevant increase in lymph node cell count was observed in the mid and highest dose group in comparison to the vehicle control group. However the cut-off value of 1.55 for a positive response in BALB/c mice was not reached in any dose group.
Overall, the substance resulted as not skin sensitiser in the LLNA assay.
A maximisation test was conducted on Similar Substance 02, using 10/females in the control group and 20/females in the test group. Upon a pretest, concentrations for induction phase and challenge application in the main test were chosen.
The intradermal injections was performed at 1 % w/v test item in water and in the FCA/physiological saline mixture. After 8 days, epidermal induction was performed with 25 % test item in vaselinum album. Challenge was carried out at day 22 and 29 at 25 % test item in vaselinum album by epidermal occlusive patch system.
Under the experimental conditions, none of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. Therefore, the substance resulted to be non skin sensitiser.
No positive reactions were reported in the available guinea pig maximisation test carried out on Similar Substance 02.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), skin sensitizer is a substance that will lead to an allergic response following skin contact.
In case of a local lymph node assay, a stimulation index ≥ 3 is considered as positive. Uner the test conditions, the simlulation index was far below 3 at all test concentrations (1 %, 2% and 5 %).
In case of a guinea pig maximisation test, a response of at least 30 % of the animals is considered as positive. Under the experimental conditions employed, 0 % of the animals of the test and control groups showed skin reactions 24 and 48 hours after removing the dressings.
On these bases, the substance was not classified as skin sensitiser, according to the CLP Regulation (EC 1272/2008).
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