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Diss Factsheets
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EC number: 629-754-4 | CAS number: 210988-99-1
- 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
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Since the results of the skin sensitization testing battery did not allow for a conclusion (1 test positive, 1 test negative, 1 test equivocal), an in vivo test was performed.
In a GLP-compliant Buehler assay following OECD guideline 406, the possible allergenic activity of the test item was evaluated after topical administration in guinea pigs. After induction of 20 guinea-pigs by 3 topical applications with the test item applied diluted at 50% in liquid paraffin under occlusive dressing and a 13-day rest phase, the challenge phase, under occlusive dressing for 6 hours, consisted of a single topical application of the test item diluted at 50% in liquid paraffin and of a negative control (liquid paraffin). In the treated group a slight to intense erythema in 100% (20/20) of the animals, 24, 48 and 72 hours after the challenge phase, was recorded on the treated area. In the control group, a slight to moderate erythema in 60% (6/10), 40% (4/10) and 30% (3/10) of the animals, 24, 48 and 72 hours after the challenge phase, was recorded on the treated area. No cutaneous reaction was recorded in animals from the treated and control groups after the challenge phase, on the treated area with liquid paraffin.
As irritation was observed in the control group animals, only reactions in the test group animals that exceeded the most severe reactions seen in the control group animals were attributed to skin sensitization. So, a sensitization reaction was noted in 60%, 50% and 20% of the animals from the treated group, 24, 48 and 72 hours after the challenge phase, on the area challenged with the test item at 50%. The severity of the reactions were 2.5, 2.45 and 2.15 in the treated group versus 0.8, 0.5 and 0.4 in the control group 24, 48 and 72 hours after the challenge phase, respectively.
To confirm the results obtained with the test item, a second challenge phase (re-challenge) was performed with the test item diluted at 25% in liquid paraffin after a 6 day rest phase. A sensitization reaction was noted in 10%, 5% and 5% of the animals from the treated group, 24, 48 and 72 hours after the challenge phase, on the area challenged with the test item at 25%. The severity of the reactions were 1.65, 1.0 and 0.2 in the treated group versus 1.0, 0.7 and 0.2 in the control group 24, 48 and 72 hours after the challenge phase, respectively. In conclusion, the test item was considered as a skin sensitizer, taking into account the result of the 1st challenge.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification for sensitization is warranted under Directive 67/548/EEC.
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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