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EC number: 203-721-0 | CAS number: 109-94-4
- 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 human maximization test was carried out to assess the dermal sensitization potential of the test chemical. 4% test chemical in petrolatum was applied to the skin of 23 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified).
4% test chemical in petrolatum did not induce any sensitization reactions on the skin of 23 human volunteers.
Hence, the test chemical was considered to be 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:
- key study
- 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: Human maximization test
- Principles of method if other than guideline:
- Human maximization test was carried out to determine the allergenic potential of the test chemical
- GLP compliance:
- no
- 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:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 4% in petrolatum
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 4% in petrolatum
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 23 human volunteers
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
- Positive control results:
- No data available
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 4% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 23
- Clinical observations:
- no dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test chemical 4% in petrolatum did not induce any sensitization reactions on the skin of 23 human volunteers.
Hence, the test chemical was considered to be not sensitizing to skin. - Executive summary:
A human maximization test was carried out to assess the dermal sensitization potential of the test chemical. The test chemical 4% in petrolatum was applied to the skin of 23 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified).
The test chemical 4% in petrolatum did not induce any sensitization reactions on the skin of 23 human volunteers.
Hence, the test chemical was considered to be not sensitizing to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In various studies, the test chemical has been investigated for potential to cause dermal sensitization to a greater or lesser extent. The studies are based on in vivo experiments in humans for test chemicals. The results are summarized as follows:
A human maximization test was carried out to assess the dermal sensitization potential of the test chemical. The test chemical 4% in petrolatum was applied to the skin of 23 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified).
The test chemical 4% in petrolatum did not induce any sensitization reactions on the skin of 23 human volunteers.
Hence, the test chemical was considered to be not sensitizing to skin.
Skin sensitization effects were also estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for the test chemical. Based on estimation, no skin sensitization reactions were observed in guinea pigs and humans. Therefore, the test chemical was considered to be not sensitizing.
These results are further supported by a human maximization test performed to evaluate the sensitization potential of the test chemical. The test chemical 3% in petrolatum was applied to the skin of 23 human volunteers and observed for dermal reactions (duration of exposure and observation period not specified). The test chemical 3% in petrolatum when tested for skin sensitization on 23 human volunteers showed no skin reaction. Hence, it can be considered as not skin sensitizer for human skin.
The above results are also supported by the results of a human maximization test performed to determine the sensitization potential of the test chemical. The test chemical 12% in petrolatum was applied to the skin of 25 human volunteers and observed for effects (duration of exposure, observation period). The test chemical 12% in petrolatum failed to induce any dermal reactions on the skin of human volunteers.
Hence the test chemical was considered to be not sensitizing to human skin.
Based on the results obtained for the test chemicals and applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation, the test chemical can be classified under the category “Not Classified”.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Available data for the test chemical indicates that it is not likely to induce any dermal reactions.
Hence, the test chemical can be considered to be not sensitizing to skin.
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