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Diss Factsheets
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EC number: 254-372-6 | CAS number: 39236-46-9
- 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
Link to relevant study records
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Report of skin sensitisation studies using two different methods (equivalent to OECD guidelines) and with sufficient detail to support study conclusions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- Separate experiments in Guinea pigs and mice
- GLP compliance:
- no
- Type of study:
- other: Guinea pig maximisation (Magnusson Kligman) test and mouse local lymph node assay
- Species:
- other: Guinea pigs and mice
- Strain:
- other: Albino Dunkin Hartley Guinea pigs, CBA/Ca mice
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Guinea pigs ca. 350g at study start: sex unspecified.
Mice 8-12 wks old: single sex used (male or female not specified) - Route:
- intradermal
- Vehicle:
- other: 0.9% saline
- Concentration / amount:
- Induction:
- intradermal injections, 2.5%
- occluded patch, 75%.
Challenge:
- occluded patch, 75% - Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.9% saline
- Concentration / amount:
- Induction:
- intradermal injections, 2.5%
- occluded patch, 75%.
Challenge:
- occluded patch, 75% - No. of animals per dose:
- Minimum 10 (deduced from citation of the method of Magnusson and Kligman, 1970)
- Details on study design:
- Induction 6x intradermal injections followed 8 days later by 48h occluded patch applicied over injection site.
Challange 12-14 days later: 24h occluded patch (maximum non-irritant concentration).
Reactions scored for erythem and oedema 24 and 48h after challenge patch removal - Challenge controls:
- Assumed to have been included, based on citation of the method of Magnusson and Kligman, 1970
- Positive control substance(s):
- not specified
- Positive control results:
- Not applicable
- Reading:
- other: Combined result from 1st and 2nd readings
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75% challenge concentration
- No. with + reactions:
- 80
- Clinical observations:
- 80% of test group reacted to challange
- Remarks on result:
- other: Reading: other: Combined result from 1st and 2nd readings. . Hours after challenge: 48.0. Group: test group. Dose level: 75% challenge concentration. No with. + reactions: 80.0. Clinical observations: 80% of test group reacted to challange.
- Parameter:
- SI
- Value:
- 1.7
- Test group / Remarks:
- 10%
- Parameter:
- SI
- Value:
- 3.1
- Test group / Remarks:
- 25%
- Parameter:
- SI
- Value:
- 5.5
- Test group / Remarks:
- 50%
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Both in vivo assay systems employed showed clear evidence of contact sensitisation following exposure to the test substance at concentrations > 10%.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The available studies lead to a conclusion that contact sensitisation occurs in vivo.
Migrated from Short description of key information:
In a Guinea pig maximisation test induction by intradermal injection (2.5%) and topical, occluded patch (75%) followed by topical patch challenge (75%) caused sensitisation reactions in 80% of test animals.
In a mouse local lymph node assay, an SI value >3 was reported for mice treated topically at 25 and 50% (and in a supporting local lymph node/ATP assay, treatment at 25% gave SI >3).
Justification for selection of skin sensitisation endpoint:
This key study shows clear evidence of contact sensitisation at concentrations > 10% in two different in vivo bioassays: Guinea pig maximisation test and mouse local lymph node assay.
Justification for classification or non-classification
The observed level of potency in the key study and supporting local lymph node assay report lead to classification as Skin Sensitiser Category 1B, H317 under the terms of the CLP Regulation as amended.
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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