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Diss Factsheets
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EC number: 217-707-7 | CAS number: 1937-19-5
- 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 following data were obtained for the Similar Substance 01. It is expected that the Target substance will present similar skin sensitisation potential. Justification for the use of a read-across approach is
provided in Section 13 of IUCLID.
The maximization test of Magnusson and Kligman was performed on male guinea pigs to determine whether test item exhibits skin sensitization properties.
This GLP study was performed according to OECD Guideline No. 406. The study was conducted with the following test concentrations:
intradermal induction: 5%
topical induction: 50 %
first challenge: 50 and 25 %
second challenge: 50 and 25 %
formulated in sterile physiological saline solution to yield a suspension.
After the first challenge the 50 % and 25% formulations led to skin redness in 20 % and 40 % of the test animals respectively. There were no skin reactions in the control group.
After the second challenge the 50 % and 25 % formulations led to skin redness in 70 % and 45 % of the test animals, respectively. There were no skin reactions in the control group.
Therefore, the test item exhibits a definitive skin-sensitization potential under the conditions of the maximization test.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In the CLP Regulation (EC) no. 1272/2008 a skin sensitizer is defined as “a substance that will lead to an allergic response following skin contact”. A substance classified as skin sensitiser (Category 1)
may be allocated to one of the two sub-categories 1A or 1B in accordance with the criteria given in Annex I, Part 3, Table 3.4.2.. If classification is based on results obtained from studies conducted in
experimental animals, the test results from the LLNA, GPMT and the Buehler assay can be used directly for classification. Guidance values are presented in the CLP Regulation (EC 1272/2008) in Annex I, Part 3, Table 3.4.3 for classification in sub-category 1A and in Annex I, Part 3, Table 3.4.4 for classification in sub-category 1B.
Based on the available results from the GPMT performed, the substance induces a sensitisation rate of 20 -70 % after an intradermal induction at 5 % and a challenge and a rechallenge epidermal application. This result meets the classification criterion for Skin sens. Cat. 1B “≥ 30 % responding at > 1 % intradermal induction dose” H317 1B, according to CLP Regulation (EC) no. 1272/2008.
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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