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EC number: 700-652-2 | CAS number: 1259300-69-0
- 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
non-skin irritant
non-eye irritant
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The skin irritation potential of the test substance was evaluated in the in-vitro EpiDerm™ reconstituted human epidermis, according to the OECD Guideline 439. EpiDerm™ tissues were exposed in triplicate to the test substance for 60 min. A positive (5 % SLS) and a negative (CMF-DPBS) control were also exposed in triplicate for 60 min. After the exposure period, the tissues were subjected to a post-treatment expression incubation at standard culture conditions for 42 hours. The cell viability after the post-exposure incubation was measured.
The mean % viability for the test substance was established to be 98.6 %. Based on the OECD 439 classification criteria the test substance can be considered as non-irritating.
Eye irritation
The potential of the test substance to induce opacity and permeability to fluorescein in an isolated bovine cornea was evaluated in the in vitro BCOP test according to the OECD Guideline 437. Bovine corneas were mounted in special holders and exposed to the test substance. Positive and negative controls run in parallel. The test and positive control corneas were exposed at 32 ± 1 °C for 10 min instead the negative control corneas for 30 min, after which the control or test treatments were removed and the corneas were rinsed and the opacity measurement was performed. The corneas were returned to the incubator for approximately 2 hrs after which a final measure of opacity was obtained. The posterior chamber was filled with fresh Complete MEM and 1 ml of 4 mg/ml fluorescein solution was added to the anterior chamber. The corneas were then incubated for 90 min at 32 ± 1 °C, after which aliquots were placed into their wells on a 96 -well plate and the optical density was determined at 490 nm (OD490).
The mean IVIS for the test substance was -1.2. Based on the classification criteria, the test substance is considered to be non-irritating to eyes.
Justification for classification or non-classification
The substance was assessed for its skin and eye irritation potential in two in-vitro studies.
Skin irritation
The substance did not induce a significant decrease in cell viability (quantified by formazan production). The cell viability was found to be 98.6 % after 60 min of exposure and 42 hours post-exposure. This value lays above the thresholds of irritation, i.e. < 50 % of negative control.
According to the CLP Regulation guidance, the classification criteria for the in-vitro skin corrosion/irritation studies are mentioned in the corresponding OECD test guideline. Based on the results of the in-vitro study and the recommendations of the OECD Guideline 439, no classification for skin irritation is proposed according to the CLP Regulation (EC) No.1272/2008.
Eye irritation
The substance has a mean in vitro irritation score (IVIS) of -1.2. Two classification systems proposed in two articles (Sina et al. 1995 and Vanparys et al. 1993) are reported in the study and suggest that the substance is not an eye irritant since it is lower even from the lowest score for classification (0 -25:mild irritant or 0 -3: non irritant). According to the CLP Regulation, negative results in the BCOP study can be used for classification purposes and no further testing is necessary. Based on the results of the in-vitro study no classification for serious eye damage/eye irritation according to the CLP Regulation (EC) No.1272/2008 is proposed.
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