Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-012-6 | CAS number: 102-19-2
- 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
A maximization test was carried out on 29 human volunteers to assess the dermal sensitization potential of test chemical. The test chemical was applied to the skin of human volunteers at a dose of 2% in petrolatum and observed for effects (duration not specified). The chemical neither caused any dermal reactions nor dermal sensitizing effects. Hence, the test chemical can be considered as not sensitizing to skin.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the dermal sensitization potential of test chemical in humans.
- GLP compliance:
- not specified
- Type of study:
- other: Human Maximization test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Human Maximization test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 2% in petrolatum
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 2% in petrolatum
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 29 human volunteers
- Details on study design:
- No data
- Challenge controls:
- No data
- Positive control substance(s):
- not specified
- Positive control results:
- No data
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 29
- Clinical observations:
- no reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test chemical did not cause any dermal reactions and no dermal sensitizing effects were observed.Hence, the test chemical can be considered to be not sensitizing to skin.
- Executive summary:
A maximization test was carried out on 29 human volunteers to assess the dermal sensitization potential of test chemical.The test chemical was applied to the skin of human volunteers at a dose of 2% in petrolatum and observed for effects (duration not specified). The chemical neither caused any dermal reactions nor dermal sensitizing effects. Hence, the test chemical can be considered as not sensitizing to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Various studies have been reviewed to determine the sensitization potential of the test chemical in living organisms. These include in vivo experimental studies performed on humans for the test chemical.
A maximization test was carried out on 29 human volunteers to assess the dermal sensitization potential of test chemical. The test chemical was applied to the skin of human volunteers at a dose of 2% in petrolatum and observed for effects (duration not specified). The chemical neither caused any dermal reactions nor dermal sensitizing effects. Hence, the test chemical can be considered as not sensitizing to skin.
This is supported by another maximization test carried out to assess the sensitization potential of the test chemical in humans 4% test chemical [2760 µg/cm2] in petrolatum was applied under occlusion to the same site on the forearms of 25 healthy male volunteers for five alternate days, 48 hours periods. The patch sites were pre-treated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a 10 day rest period, challenge patches were applied to fresh sites on the back for 48 h under occlusion. The challenge site was pre-treated for 1 h with 10% SLS. The challenge site was evaluated at 48 and 72 hours. On evaluation of the challenge site at 48 and 72 hours, no sensitization reactions were observed. Hence, the test chemical was considered to be non-sensitizing to skin in humans.
The above maximization test results are further supported by a similar human maximization test carried out to assess the dermal sensitization potential of the test chemical. The test chemical 8% in petrolatum was applied to the skin of 25 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified). The test chemical 8% in petrolatum did not induce any sensitization reactions on the skin of 25 human volunteers. Hence, the test chemical was considered to be not sensitizing to skin.
Based on the available studies and applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. It can be further classified under the category “Not Classified” as per CLP Regulation.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available studies and applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. It can be further classified under the category “Not Classified” as per CLP Regulation.
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.