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Diss Factsheets
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EC number: 935-853-6 | CAS number: -
- 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
The test material was considered to be Irritant according to the EU labelling regulations during the dermal irritation study. The symbol “I” and the risk phrase R 38 “IRRITATING TO SKIN” are therefore required.
The test material did not meet the criteria for classification as an irritant (to the eye) according to the EU labelling regulations. No symbol or risk phrases are required.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin Irritancy/Corrosion:
A study was performed to assess the skin irritation potential of the test material using the EPISKINTMreconstituted human epidermis model after a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours. The principle of the assay was based on the measurement of cytotoxicity in reconstituted human epidermal cultures following topical exposure to the test material by means of the colourimetric MTT reduction assay.
The test material was considered to be Irritant. The symbol “I” and the risk phrase R 38 “IRRITATING TO SKIN” are therefore required.
A study was performed to assess the corrosivity potential of the test material using the EPISKINTMin vitro Reconstituted Human Epidermis (RHE) Model after treatment periods of 3, 60 and 240 minutes. This method was designed to meet the requirements of the OECD Guideline for the Testing of Chemicals No. 431 “In Vitro Skin Corrosion: Human Skin Model Test” (adopted 13 April 2004).
The test material was considered to be Non-Corrosive to the skin.
A study was performed to assess the ocular irritancy potential of the test material in the rabbit following application onto the cornea of the enucleated eye. The results of the study are believed to be of value in predicting the ocular irritation potential of the test material in man.
0.1 ml of the test material was applied onto the cornea of each of three enucleated eyes which had been maintained at a temperature of 32 °C ± 1.5 °C within the superfusion chamber. A further two enucleated eyes were treated, for control purposes, with saline solution (0.9 % Sodium Chloride).
Following assessment of the data for all endpoints the test material was considered unlikely to have the potential to cause severe ocular irritancy in vivo.
The in vivo skin irritation study was waived since the submission substance had already been classified as an irritant in the in vitro skin irritation study using the EPISKINTM reconstituted Human Epidermis Model.
Eye Irritation
A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted)Method B5 Acute Toxicity (Eye Irritation) of CommissionRegulation (EC) No. 440/2008 and Method B5 Acute Toxicity (Eye Irritation) of CommissionRegulation (EC) No. 440/2008.
A single application of the test material to the non-irrigated eye of two rabbits produced iridial inflammation and moderate conjunctival irritation. One treated eye appeared normal at the 7-Day observation and the remaining treated eye appeared normal at the 14-Day observation.
The test material produced a maximum group mean score of 17.0 and was classified as a moderate irritant (Class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.
A study was performed to assess the ocular irritancy potential of the test material in the rabbit following application onto the cornea of the enucleated eye. The results of the study are believed to be of value in predicting the ocular irritation potential of the test material in man.
0.1 ml of the test material was applied onto the cornea of each of three enucleated eyes which had been maintained at a temperature of 32°C ± 1.5°C within the superfusion chamber. A further two enucleated eyes were treated, for control purposes, with saline solution (0.9% Sodium Chloride).
Following assessment of the data for all endpoints the test material was considered unlikely to have the potential to cause severe ocular irritancy in vivo.
Effects on skin irritation/corrosion: irritating
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
The test material was considered to be Irritant according to the EU labelling regulations during the dermal irritation study. The symbol “I” and the risk phrase R 38 “IRRITATING TO SKIN” are therefore required.
The test material did not meet the criteria for classification as an irritant to the eye according to the EU labelling regulations. No symbol or risk phrases are required.
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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