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EC number: 205-047-2 | CAS number: 132-16-1
- 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
Data available for the structurally similar read across chemicals has been reviewed to estimate the skin sensitization potential of the test chemical. Based on the summarized studies for target chemical and its structurally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, the test chemical can-not be classified as 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:
- 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:
- Data for the target chemical is summarized based on the structurally similar read across chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The skin sensitization potential of test chemical was assessed on the basis of various summarized studies which were conducted on guinea pigs and represented as study 1, 2 and 3 for WoE-2,WoE-3 and WoE-4 respectively.
- GLP compliance:
- not specified
- Type of study:
- other: Study 1:Buehler test ; Study 2: guinea pig maximisation test; Study 3:not specified
- Justification for non-LLNA method:
- Currently no LLNA Study is available for assessment.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Route:
- other: Study 1:epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.5 ml of 1% w/v aqueous suspension
- Day(s)/duration:
- nine applications for 5 hours
- Adequacy of induction:
- not specified
- Route:
- other: Study 2:intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.1 mL 1% aqueous solution
- Day(s)/duration:
- 3 times/day for 5 days
- Adequacy of induction:
- not specified
- Route:
- other: Study 3: epicutaneous,
- Vehicle:
- other: 10% oil suspension
- Concentration / amount:
- test chemical in 10% oil suspension
- Day(s)/duration:
- Not specified
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- other: Study 1:epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.5 ml of 1% w/v aqueous suspension
- Day(s)/duration:
- 5 hours
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- other: Study 2:epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.1 mL of 1% aqueous solution
- Day(s)/duration:
- not specified
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- other: Study 3: epicutaneous, occlusive
- Vehicle:
- other: 10% oil suspension
- Concentration / amount:
- test chemical in 10% oil suspension
- Day(s)/duration:
- not specified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Study 1:10 albino guinea pigs
Study 2:not specified
Study 3:no data available - Details on study design:
- Study 1:
RANGE FINDING TESTS: NO DATA AVAILABLE
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 5 h
- Test groups: 10
- Control group: NO DATA AVAILABLE
- Site: no data available
- Frequency of applications:
- Duration: 9 topical application for 5 hours
- Concentrations: 0.5 ml of 1% w/v aqueous suspension
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: no data available
- Exposure period: 5 hours
- Test groups: 10
- Control group: 4
- Site: no data available
- Concentrations: 0.5 ml of 1% w/v aqueous suspension
- Evaluation (hr after challenge): The application sites were graded for irritation (according to Draize, 1965) 24 and 48 hrs after the challenge.
OTHER: During the induction phase, Dermal irritation readings were recorded according to Draize (1965) at 24 and 48 hrs after each application.The application sites were graded for irritation (according to Draize, 1965) 24 and 48 hrs after the challenge.
Study 2:MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 times/day
- Exposure period: 5 days
- Test groups: not specified
- Control group: not specified
- Site: not specified
- Frequency of applications: 3 times
- Duration: 0.1 ml 1% aqueous solution
- Concentrations:
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Concentrations: 0.1 mL of 1% aqueous solution
Study 3: :not specified - Challenge controls:
- Study 1:Four unexposed control animals taken from the same population also received duplicate topical patches of the same dose during the challenge phase.
Study 2:not specified
Study 3:not specified - Positive control substance(s):
- not specified
- Reading:
- other: Study 1: 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5 ml of 1% w/v aqueous suspension
- No. with + reactions:
- 0
- Clinical observations:
- No evidence of dermal sensitization was observed. No abnormal clinical signs were observed during the study.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Study 2:1st reading
- Group:
- test chemical
- Dose level:
- 0.1 mL of 1% aqueous solution
- No. with + reactions:
- 0
- Clinical observations:
- no dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Study 3:1st reading
- Group:
- test chemical
- Dose level:
- Test chemical in a 10% oil suspension
- No. with + reactions:
- 0
- Clinical observations:
- No skin sensitization was observed in treated guinea pigs.
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: Not sensitising
- Conclusions:
- Based on the result obtained from the studies available for the structurally read across chemical, it can be estimated that the test chemical is unable to cause skin sensitization and thus can be considered as not sensitizing.
- Executive summary:
The skin sensitization potential of test chemical was estimated on the basis of various summarized studies available for the structurally read across chemicals which were conducted on guinea pigs and humans. These studies have been summarized as below;
Study 1:
Buehler test was performed to determine the allergic potential of the test chemical in guinea pigs. Ten albino guinea pigs were used for the test. All test animals received nine topical applications of the test article (0.5 ml of 1% w/v aqueous suspension) during the induction phase. Each application was patched for 5 hrs. Two weeks after the last exposure, the test animals were challenged for 5 hours with duplicate topical patches of the same dose as described in the induction phase. Four unexposed control animals taken from the same population also received duplicate topical patches of the same dose during the challenge phase. During the induction phase, dermal irritation readings were recorded according to Draize (1965) at 24 and 48 hrs after each application. The application sites were graded for irritation (according to Draize, 1965) 24 and 48 hours after the challenge. No evidence of dermal sensitization was observed. No abnormal clinical signs were observed during the study. Hence, the test chemical can be considered to be not sensitizing to skin of guinea pigs.
Study 2:
The skin sensitization study was performed on guinea pigs to observe the sensitizing efficacy of the test chemical. Guinea pigs were induced with intracutaneous injections of a 0.1 mL 1% aqueous solution 3 times/day for 5 days. After 4 weeks, animals were topically challenged with 0.1 mL of 1% aqueous solution. Since guinea pigs did not show any cutaneous reaction, the test material was considered to be non-sensitizing.
Study 3:
Skin sensitization study was conducted to determine the skin sensitization potential of test chemical. When the test chemical was applied on skin at concentration of test chemical in a 10% oil suspension (30- times), no skin sensitization reactions were observed. Therefore, the test chemical was considered as not sensitizing to the skin of treated guinea pigs.
The aim of the above summarized studies was to investigate the possibility of causing contact sensitization by the test chemical via dermal route. These studies were performed for the structurally similar read across chemical on humans and guinea pigs by using different test methods. Overall, the results indicate that there is no strong evidence from which we can conclude that the chemical is a potential contact allergen. Thus an interpretation can be drawn from these studies, that the chemical is not able to cause skin sensitization and hence can be considered as not sensitizing on skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitization potential of test chemical was estimated on the basis of various summarized studies available for the structurally read across chemicals which were conducted on guinea pigs and humans. These studies have been summarized as below;
Study 1:
Buehler test was performed to determine the allergic potential of the test chemical in guinea pigs. Ten albino guinea pigs were used for the test. All test animals received nine topical applications of the test article (0.5 ml of 1% w/v aqueous suspension) during the induction phase. Each application was patched for 5 hrs. Two weeks after the last exposure, the test animals were challenged for 5 hours with duplicate topical patches of the same dose as described in the induction phase. Four unexposed control animals taken from the same population also received duplicate topical patches of the same dose during the challenge phase. During the induction phase, dermal irritation readings were recorded according to Draize (1965) at 24 and 48 hrs after each application. The application sites were graded for irritation (according to Draize, 1965) 24 and 48 hours after the challenge. No evidence of dermal sensitization was observed. No abnormal clinical signs were observed during the study. Hence, the test chemical can be considered to be not sensitizing to skin of guinea pigs.
Study 2:
The skin sensitization study was performed on guinea pigs to observe the sensitizing efficacy of the test chemical. Guinea pigs were induced with intracutaneous injections of a 0.1 mL 1% aqueous solution 3 times/day for 5 days. After 4 weeks, animals were topically challenged with 0.1 mL of 1% aqueous solution. Since guinea pigs did not show any cutaneous reaction, the test material was considered to be non-sensitizing.
Study 3:
Skin sensitization study was conducted to determine the skin sensitization potential of test chemical. When the test chemical was applied on skin at concentration of test chemical in a 10% oil suspension (30- times), no skin sensitization reactions were observed. Therefore, the test chemical was considered as not sensitizing to the skin of treated guinea pigs.
The aim of the above summarized studies was to investigate the possibility of causing contact sensitization by the test chemical via dermal route. These studies were performed for the structurally similar read across chemical on humans and guinea pigs by using different test methods. Overall, the results indicate that there is no strong evidence from which we can conclude that the chemical is a potential contact allergen. Thus an interpretation can be drawn from these studies, that the chemical is not able to cause skin sensitization and hence can be considered as not sensitizing on skin.
Justification for classification or non-classification
The skin sensitization potential of test chemical and its structurally similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the test chemical is unlikely to cause skin sensitization and hence can-not be classified as a skin sensitizer.
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