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Diss Factsheets
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EC number: 222-619-7 | CAS number: 3558-60-9
- 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
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Endpoint summary
Administrative data
Description of key information
The skin sensitization potential of test chemical was assessed in various experimental studies conducted on human subjects. Based on the available data for the test chemical and supporting studies, it can be concluded that the test chemical is unable to cause skin sensitization and thus can be considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “non-Skin Sensitizer”.
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:
- 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:
- A human maximization test was carried out to assess the dermal sensitization potential of the test chemical.
- 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 Guinea Pig Maximization Test (GPMT) 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
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8% in petrolatum
- Day(s)/duration:
- no data available
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8% in petrolatum
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 24 hours
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
- Key result
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 8% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 24
- Clinical observations:
- no signs of dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test chemical 8% in petrolatum did not induce any sensitization reactions on the skin of 24 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 8% in petrolatum was applied to the skin of 24 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 24human 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:
Various studies have been reviewed to ascertain the degree of dermal sensitization caused by the test chemical in living organisms. These include in vivo experimental studies on humans, guinea pigs for the test chemicals. The results are mentioned below:
A human maximization test was carried out to assess the dermal sensitization potential of the test chemical. The test chemical 8% in petrolatum was applied to the skin of 24 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 24human volunteers. Hence, the test chemical was considered to be not sensitizing to skin.
In another study,the test chemical is added to 1% aqueous cream and hydrous ointment as a preservative. A standard patch testing series was performed with the ingredients of aqueous cream in 2736 patients to identify potential skin sensitizers present in the formulation. 1% test chemical in petrolatum failed to induce any signs of irritation or sensitization at 2 or 4 days after application. Hence the test chemical can be considered to be not sensitizing to human skin.
The above results are further supported by a human repeated insult patch test (HRIPT) which was conducted on 39 volunteers to assess the contact sensitization potential of test chemical.Each subject was induced with 1.2% of test chemical in EtOH three times per week for 3 weeks under occlusive condition. After induction, all the treated subjects were challenged at same concentration used in induction and later observed for skin reactions after 24 hours. None of the volunteers showed any signs of skin sensitization. Hence the test chemical was considered to be not sensitizing to the skin of human subjects.
Available results for the test chemical indicate a possibility that the test chemical is not likely to cause any dermal reactions to the skin. Hence, the test chemical can be considered to be not sensitizing to skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The skin sensitization potential of test substance was observed in various studies. The results obtained from these studies concluded that the chemical is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.
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.
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