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EC number: 203-013-1 | CAS number: 102-20-5
- 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
Skin Sensitization:
A maximization test was carried out to assess the dermal sensitization potential of the test chemical in humans. The test chemical was applied in concentration 2% in petrolatum to the skin of 25 human volunteers and observed for signs of dermal irritation or sensitization. No sensitization reactions were observed in any of the volunteers. Hence, the test chemical can be considered to be not sensitizing to human skin.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 the test chemical in humans
- GLP compliance:
- not specified
- Type of study:
- other: Human Maximization test
- Justification for non-LLNA method:
- Not specified
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data available
- Route:
- other: no data
- Vehicle:
- petrolatum
- Concentration / amount:
- 2% in petrolatum
- Day(s)/duration:
- no data available
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- other: no data
- Vehicle:
- petrolatum
- Concentration / amount:
- 2% in petrolatum
- Day(s)/duration:
- no data available
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 25 human volunteers
- Details on study design:
- no data available
- Challenge controls:
- no data available
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 2% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- No sensitization reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- No sensitization reactions were observed in any of the volunteers. Hence, the test chemical can be considered to be not sensitizing to human skin.
- Executive summary:
A maximization test was carried out to assess the dermal sensitization potential of the test chemical in humans. The test chemical was applied in concentration 2% in petrolatum to the skin of 25 human volunteers and observed for signs of dermal irritation or sensitization. No sensitization reactions were observed in any of the volunteers. Hence, the test chemical can be considered to be not sensitizing to human skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Various studies have been reviewed to ascertain the extent of dermal sensitization caused by the test chemical. These include in vivo experiments performed on humans as well as guinea pigs. The results are as follows:
A maximization test was carried out to assess the dermal sensitization potential of the test chemical in humans. The test chemical was applied in concentration 2% in petrolatum to the skin of 25 human volunteers and observed for signs of dermal irritation or sensitization. No sensitization reactions were observed in any of the volunteers. Hence, the test chemical can be considered to be not sensitizing to human skin.
This result is supported by a Repeated insult patch test performed in humans to assess the dermal sensitization potential of the test chemical. 2% of the test chemical was tested using eleven 24 hour exposures to the skin of 40 human volunteers and observed for signs of dermal irritation or sensitization (duration not specified). No sensitization reactions were observed in any of the volunteers. Hence, the test chemical can be considered to be not sensitizing to human skin.
The above repeated insult patch test result is also supported by a similar repeated insult patch test was performed in humans to assess the dermal sensitization potential of the test chemical. 2% of the test chemical was tested using eleven 48 hour exposures to the skin of 105 human volunteers and observed for signs of dermal irritation or sensitization (duration not specified). No sensitization reactions were observed in any of the volunteers. Hence, the test chemical can be considered to be not sensitizing to human skin.
These results are further supported by a human 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.
Based on the available results and applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Hence, the test chemical can be 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 results and applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Hence, the test chemical can be 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.
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