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Diss Factsheets
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EC number: 201-861-7 | CAS number: 88-85-7
- 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
Three reliable studies are available for determining the irritation/corrosion to skin, and one for the eye irritation endpoint:
Skin irritation/corrosion:
Liggett & Parcell, 1984, was conducted according to the OECD 404 guideline and was allocated a reliability score of 2 according to the criteria of Klimisch et al, 1997. The study was conducted upon rabbits in vivo using a substance containing the registered substance at 30-31.2w/w in oil (applied unchanged). Mean erythema scores of 2 (max 2) were reported at 24 and 48 hours and 1.7 (max 2) at 72 hours (fully reversible within 10 days). Mean oedema scores of 1 (max 1) were reported at 24, 48 and 72 hours (fully reversible within 9 days) based upon these results no classification was appropriate.
Warren, 2010, evaluated the irritation potential in vitro, using the EpiSkin TM reconstituted human epidermal model for which a specific OECD guideline (439) was adopted on 22 July 2010, under GLP. The results of this study indicate that the substance is irritating to the skin and requires labelling with R38.
Whittingham, 2010, evaluated the corrosion potential in vitro, using the EpiSkin TM reconstituted human epidermal model, according to OECD guideline 431 and under GLP. The substance resulted to be non-corrosive to the skin.
Eye irritation:
Liggett & Parcell, 1984, was performed according to the OECD 405 guideline and was conducted upon rabbits in vivo. The study was allocated a reliability score of 2 according to the Klimisch et al, 1997, criteria. The study reported increasingly severe scores for the cornea and chemosis (24 hours mean: 2, max: 2), (48 and 72 hours mean: 2.3 max: 3 for both examinations). However with the exception of the cornea in 1 animal, all results were fully reversible within 21 days. Based upon these results, the substance was considered irritating to eye, requiring labelling as R41, Risk of serious damage to eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
The available data were adequate for the regulatory purpose required and for a basis for classification. Although in vivo data did not trigger for classification for skin irritation, the study was performed with a substance containing only ca. 30% of the registered substance. In the in vitro study evaluating irritation potential to the skin, the 97% pure registered substance was used and therefore this study was considered more appropriate for classification purposes.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
Based upon the above information the registered substance meets the classification set out in 67/548/EEC and EC Regulation 1272/2008 and should therefore be classified as follows:
R38 - irritating to skin;
R41 - Risk of serious damage to eyes
Skin Irritation/Corrosion category 2, H315 Causes skin irritation;
Eye irritation category 1, H318 Causes serious eye damage
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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