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Diss Factsheets
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EC number: 200-607-2 | CAS number: 65-31-6
- 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
Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Weight of evidence approach based on various test chemicals
- Justification for type of information:
- Weight of evidence approach based on various test chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: Weight of evidence approach based on various test chemicals
- Principles of method if other than guideline:
- Weight of evidence approach based on various test chemicals. The study 2,3 are referred as study 1,2
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence approach based on various test chemicals
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- male/female
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5% aqueous test chemical
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 1% aqueous test chemical
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5% aqueous test chemical
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 1% aqueous test chemical
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1. 14 patients
2. 14 patients - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Group:
- test chemical
- No. with + reactions:
- 0
- Clinical observations:
- no dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can 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”.
- Executive summary:
Various studies have been summarized to ascertain the level of dermal sensitization caused by test chemical in living organisms. These results include in vivo experimental studies performed on humans, for the test chemicals.
Patch tests were performed with aqueous solution of test chemical to determine the degree of allergenic reactions.
Patch tests were carried out with European Standard series except for primin(TRUE TEST) with 5% aqueous test chemical were tested. The patches were applied to the backs of 14 volunteers (10male and 5 female) and were read at 2 and 3 days according to the recommendations of the ICDRG.
Positive patch test reactions were further assessed as irritant or allergic.
Positive reactions were observed in only 1 volunteer. The test chemical was considered to be an insensitive test agent, mostly due to its poor solubility.
Hence, the test chemical can be considered to be not sensitizing to skin.
This is supported by the results of a patch test conducted to determine the degree of contact sensitization caused by the chemical.
The patches were applied to the backs of 14 volunteers (10male and 5 female) at concentration of 1% of aqueous solution of test chemical and were read at 2 and 3 days according to the recommendations of the ICDRG. Positive patch test reactions were further assessed as irritant or allergic.
Since only one volunteer had positive reaction out of 14 patients, the test material was considered as not sensitizing to the skin at tested concentration.
Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Various studies have been summarized to ascertain the level of dermal sensitization caused by test chemical in living organisms. These results include in vivo experimental studies performed on humans, for the test chemicals.
Patch tests were performed with aqueous solution of test chemical to determine the degree of allergenic reactions.
Patch tests were carried out with European Standard series except for primin(TRUE TEST) with 5% aqueous test chemical were tested. The patches were applied to the backs of 14 volunteers (10male and 5 female) and were read at 2 and 3 days according to the recommendations of the ICDRG.
Positive patch test reactions were further assessed as irritant or allergic.
Positive reactions were observed in only 1 volunteer. The test chemical was considered to be an insensitive test agent, mostly due to its poor solubility.
Hence, the test chemical can be considered to be not sensitizing to skin.
This is supported by the results of a patch test conducted to determine the degree of contact sensitization caused by the chemical.
The patches were applied to the backs of 14 volunteers (10male and 5 female) at concentration of 1% of aqueous solution of test chemical and were read at 2 and 3 days according to the recommendations of the ICDRG. Positive patch test reactions were further assessed as irritant or allergic.
Since only one volunteer had positive reaction out of 14 patients, the test material was considered as not sensitizing to the skin at tested concentration.
Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can 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”.
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