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EC number: 216-223-3 | CAS number: 1530-32-1
- 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
The available studies for the test chemicals indicate a possibility that it is not likely to cause any sensitization to skin. Hence, 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.
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:
- Experimental data from various test chemicals
- Justification for type of information:
- Weight of evidence approach based on the available information from various test chemicals.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- WoE report is based on skin sensitization studies on guinea pig and rabbits.
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence approach based on the available information from various test chemicals.
- 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: 1.guinea pig 2.rabbits
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
- Route:
- intradermal
- Vehicle:
- peanut oil
- Concentration / amount:
- 5 %
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- 75%
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- 75%
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Study 1
10
Study 2
4 - Details on study design:
- Study 1
Details on study design
RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:2
- Exposure period: No data available
- Test groups:10
- Control group: No data available
- Site: No data available
- Frequency of applications: No data available
- Duration: No data available
- Concentrations: 1st: Induction 5 % intracutaneous
2nd: Induction 75 % occlusive epicutaneous
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: No data available
- Exposure period: No data available
- Test groups:10
- Control group: No data available
- Site: No data available
- Concentrations:75%
- Evaluation (hr after challenge): - Challenge controls:
- No data available
- Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No sensitization reaction observed
- Remarks on result:
- other: Not sensitizing
- Reading:
- 1st reading
- Group:
- positive control
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Clinical observations:
- sensitization reaction observed
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- . Test material produced a slight irritation in 2 to 4 rabbits. But no indications of sensitizing properties were found on challenge treatment after 14 day.
- Remarks on result:
- other: Not sensitizing
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- Available studies for the test chemical indicate a possibility that it is not likely to cause any sensitization to skin. Hence, 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.
- Executive summary:
Various studies have been summarized to determine the ability of the test chemical to cause dermal sensitization in living organisms. These studies include in vivo experimental results on Guinea Pig and rabbits for the test chemical.
Study 1
The skin sensitization study of test material was performed in guinea pig using OECD Guideline 406. The test material mixed with vehicle peanut oil. 10 animals were used in test group whereas 9 animals were used in positive control group. Mercaptobenzothiazole used as positive control. The first Induction given using 5 % concentration of test material via intracutaneous route while in second induction test material in 75% concentration applied occlusive epicutaneous route. The challenge was given using 75% concentration of test material via occlusive epicutaneous route. In positive control group all 9 animals showed sensitization reaction while in test group none of the animals showed positive skin sensitization reaction. Hence test material was considered to be not sensitizing in guinea pig.
Study 2
The skin sensitization study of test material was performed on 4 rabbits using patch test. Undiluted test material was applied on rabbit’s skin using patch. Test material produced a slight irritation in 2 to 4 rabbits. But no indications of sensitizing properties were found on challenge treatment after 14 day. Hence the test material was considered to be not sensitizing in rabbits.
Available studies for the test chemical indicate a possibility that it is not likely to cause any sensitization to skin. Hence, 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitization
Various studies have been summarized to determine the ability of the test chemical to cause dermal sensitization in living organisms. These studies include in vivo experimental results on Guinea Pig and rabbits for the test chemical.
WoE 2:
The skin sensitization study of test material was performed in guinea pig using OECD Guideline 406. The test material mixed with vehicle peanut oil. 10 animals were used in test group whereas 9 animals were used in positive control group. Mercaptobenzothiazole used as positive control. The first Induction given using 5 % concentration of test material via intracutaneous route while in second induction test material in 75% concentration applied occlusive epicutaneous route. The challenge was given using 75% concentration of test material via occlusive epicutaneous route. In positive control group all 9 animals showed sensitization reaction while in test group none of the animals showed positive skin sensitization reaction. Hence test material was considered to be not sensitizing in guinea pig.
WoE 3:
The skin sensitization study of test material was performed on 4 rabbits using patch test. Undiluted test material was applied on rabbit’s skin using patch. Test material produced a slight irritation in 2 to 4 rabbits. But no indications of sensitizing properties were found on challenge treatment after 14 day. Hence the test material was considered to be not sensitizing in rabbits.
Available studies for the test chemical indicate a possibility that it is not likely to cause any sensitization to skin. Hence, 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
Available studies for the test chemicals indicate a possibility that it is not likely to cause any sensitization to skin. Hence, 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.
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