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Diss Factsheets
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EC number: - | 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
No skin sensitising effects were observed in a Buehler test according to OECD guideline 406 (BASG SE, 32H0567/14X342, 2015).
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The dermal sensitizing potential of the test substance was investigated on the basis of the methods of the OECD Guideline 406 (1992), the council regulation (EC) No 440/2008 part B.6. (2008) and the U.S. EPA guideline OPPTS 870.2600 (2003) (BASF SE, 32H0567/14X342, 2015). The test developed by Buehler (1965) and known as Buehler test was used.
The main study was performed on 30 guinea pigs in total. A control group of 10 animals and a test group of 20 animals were formed. The test concentrations for the main study were selected based on the results of a preliminary investigation.
The main study started with an induction phase including an occlusive patch topical application for 6 hours once a week for three consecutive weeks. The animals of the test group (group 2) were induced with the 50 % (w/w) test item in 1 % (w/w) carboxymethylcellulose sodium salt (CMC), whereas the animals of the control group (group 1) were induced with 1 % (w/w) CMC only.
None of the animals of the control group and the test group showed signs of skin irritation during the induction phase.
Four weeks after the first induction, the 6-hour challenge procedure followed by an occlusive topical application of the test item on the right flank of all animals. The skin reactions were evaluated 24 hours and 48 hours after the challenge application. For the challenge, the test item was used in a concentration of 50 % (w/w) in 1 % CMC (w/w). None of the animals of the test group and the control group responded with skin reactions to the challenge treatment with the test item and the vehicle.
Due to the absence of positive skin reactions in the test group (0 %, 0/20) compared to the control group being free of any reactions, a sensitization potential of the test item has not been shown in the challenge. A rechallenge was not required by the sponsor.
Under the experimental conditions described in this report, the test item did not supply evidences for delayed contact hypersensitivity. Based on the results of the non-adjuvant sensitization study described in this final report, the test item did not show a skin sensitizing potential.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the study data and taking into account the provisions laid down in Regulation (EC) No 1272/2008 as amended for the ninth time in Regulation (EU) No 2016/1179, the test substance does not need to be classified as skin sensitising.
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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