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Diss Factsheets
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EC number: 947-377-6 | 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
According to clinical study (human patch test) the test item was considered as non-sensitising.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation, other
- Remarks:
- Human Patch Test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Human Patch Test
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Repeated Insult Patch Test was performed to confirm that repeated applications of the product under maximized conditions, in healthy subjetcs, does not induce delayed contact allergy reactions. A secondary objective is to determine the irritating potential of the product first after a single application and second after repeated applications.
- GLP compliance:
- no
- Type of study:
- patch test
- Justification for non-LLNA method:
- Patch test study in human volunteers already available
- Specific details on test material used for the study:
- 8% in petrolatum
- Species:
- other: human
- Sex:
- male
- Details on test animals and environmental conditions:
- - Number of subjects completing the study: 25 healthy, male volunteers
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 8% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under these study conditions, the tes item can be considered non-sensitizing.
- Executive summary:
A maximalisation test was conducted in 25 healthy, male volunteers. Applications of the test material in petrolatum were made under occlusion to the same site on the forearms of all subjects for five alternate-day 48 hour periods. Patch sites were pretreated for 24 hours with 5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a ten day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 1-hourapplications of 10% aqueous SLS under occlusion. Reactions were read on patch removal and 24 hours after patch removal. No effect was observed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A maximalisation test was conducted in 25 healthy, male volunteers. Applications of the test material in petrolatum were made under occlusion to the same site on the forearms of all subjects for five alternate-day 48 hour periods. Patch sites were pretreated for 24 hours with 5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a ten day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 1-hour applications of 10% aqueous SLS under occlusion. Reactions were read on patch removal and 24 hours after patch removal. No effect was observed.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Harmonized classification:
The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
In a human patch test, the test item was tested at 8% in petrolatum and it was concluded to be non-sensitising. Based on this result, the registered substance is not expected to need to be classified as skin sensitiser.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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.