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EC number: 210-568-3 | CAS number: 618-88-2
- 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
Positive erythema reactions (i.e., a score >= 2) were observed in only one test article–treated guinea pig, compared to no vehicle or sham control guinea pigs during the challenge phase. Since no sensitization reactions were observed in majority of treated animals, the chemical was considered as not sensitizing to the skin of guinea pigs.
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 of read across substances
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- WoE derived based on the experimental data from structurally and functionally similar read across chemicals
- GLP compliance:
- not specified
- Type of study:
- other: 2. Buehler test 3.not specified
- 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:
- guinea pig
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- No data available
- Route:
- epicutaneous, occlusive
- Vehicle:
- DMSO
- Concentration / amount:
- 30% (0.3mL)
- Day(s)/duration:
- 3 weeks
- Adequacy of induction:
- other: not specified/2
- Route:
- epicutaneous, open
- Vehicle:
- other: 1% aqueous duponol
- Concentration / amount:
- 50%
- Day(s)/duration:
- not specified
- Adequacy of induction:
- other: not specified/3
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- DMSO
- Concentration / amount:
- 30% (0.3mL)
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- other: not specified / 2
- No. of animals per dose:
- 2. 30 (10 guinea pigs/Group)
3. Not specified - Details on study design:
- 2. MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: no data
- Test groups: 10 guinea pigs
- Control group: 10 guinea pigs
- Site: shaved backs
- Frequency of applications: once a week
- Duration: 3 weeks
- Concentrations: 30% (0.3mL)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 2 weeks
- Exposure period: 24 hours
- Test groups: 10 guinea pigs
- Control group: 10 guinea pigs
- Site: no data
- Concentrations: 30% (0.3mL)
- Evaluation (hr after challenge): 24 hours and 48 hours
3.The test chemical was applied as a 50% paste in 1% aqueous duponol to the intact skin of Guinea Pigs. - Challenge controls:
- 2. The sham control guinea pigs each received a challenge dose of 0.3 ml of the 30% test article/DMSO solution; the vehicle control guinea pigs each received a challenge dose of 0.3 ml of a 70% (w/w) aqueous DMSO solution.
3. Not specified - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30% (0.3mL)
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Positive erythema reactions (i.e., a score >= 2) were observed in only one test article–treated guinea pig, compared to no vehicle or sham control guinea pigs during the challenge phase.
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- 2
- Reading:
- 1st reading
- Group:
- other: Not specified
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- 3
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- Positive erythema reactions (i.e., a score >= 2) were observed in only one test article–treated guinea pig, compared to no vehicle or sham control guinea pigs during the challenge phase. Since no sensitization reactions were observed in majority of treated animals, the chemical was considered as not sensitizing to the skin of guinea pigs.
- Executive summary:
Skin sensitization study was performedcon guniea pig to dtermine the sensitization potential of test chemicals. The studies are summarized below:
A Buehler Test was conducted on ten male guinea pigs for chemical to assess its skin sensitization potential. Test chemical was applied once a week at a dose of 0.3ml of a 30% (w/w) solution in dimethylsulfoxide (DMSO) to the shaved backs of ten male guinea pigs during an induction period of three weeks. Another group of 10 male guinea pigs served as a vehicle control and was similarly dosed with 0.3ml of undiluted DMSO. A third group of ten sham control guinea pigs was handled in the same manner, but was not treated with test article or vehicle. Two weeks following application of the third induction dose, the treated andsham control guinea pigs each received a challenge dose of 0.3 ml of the 30% test article/DMSO solution; the vehicle control guinea pigs each received a challenge dose of 0.3 ml of a 70% (w/w) aqueous DMSO solution. All guinea pigs were scored for erythema approximately 24 and 48 hours following application of the first induction dose and the challenge dose. Positive erythema reactions (i.e., a score >= 2) were observed in only one test article–treated guinea pig, compared to no vehicle or sham control guinea pigs during the challenge phase. Since no sensitization reactions were observed in majority of treated animals, the chemical was considered as not sensitizing to the skin of guinea pigs.
In another study, Skin sensitization test was performed on Guinea pig to determine the sensitization potential of test chemical. The test chemical was applied as a 50% paste in 1% aqueous solution of Duponol to intact skin of Guinea pig. No indication of clinical signs suggests that the test chemical is not sensitizing to the skin of Guinea pig. Hence the test chemical is 'Not sensitizing' in nature.
Thus, comparing above studies it can be concluded that the test chemical is not sensitizing in nature.
Reference
The primary effect of treatment (treated vs. control) and the secondary effect of time of scoring (24 hr vs. 48 hr) were not statistically significant. These findings indicate that dermal sensitization did not result from repeated dermal application of Isophthalic acid.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitization study was performedcon guniea pig to dtermine the sensitization potential of test chemicals. The studies are summarized below:
A Buehler Test was conducted on ten male guinea pigs for chemical to assess its skin sensitization potential. Test chemical was applied once a week at a dose of 0.3ml of a 30% (w/w) solution in dimethylsulfoxide (DMSO) to the shaved backs of ten male guinea pigs during an induction period of three weeks. Another group of 10 male guinea pigs served as a vehicle control and was similarly dosed with 0.3ml of undiluted DMSO. A third group of ten sham control guinea pigs was handled in the same manner, but was not treated with test article or vehicle. Two weeks following application of the third induction dose, the treated andsham control guinea pigs each received a challenge dose of 0.3 ml of the 30% test article/DMSO solution; the vehicle control guinea pigs each received a challenge dose of 0.3 ml of a 70% (w/w) aqueous DMSO solution. All guinea pigs were scored for erythema approximately 24 and 48 hours following application of the first induction dose and the challenge dose. Positive erythema reactions (i.e., a score >= 2) were observed in only one test article–treated guinea pig, compared to no vehicle or sham control guinea pigs during the challenge phase. Since no sensitization reactions were observed in majority of treated animals, the chemical was considered as not sensitizing to the skin of guinea pigs.
In another study, Skin sensitization test was performed on Guinea pig to determine the sensitization potential of test chemical. The test chemical was applied as a 50% paste in 1% aqueous solution of Duponol to intact skin of Guinea pig. No indication of clinical signs suggests that the test chemical is not sensitizing to the skin of Guinea pig. Hence the test chemical is 'Not sensitizing' in nature.
Thus, comparing above studies it can be concluded that the test chemical is not sensitizing in nature.
Justification for classification or non-classification
The skin sensitization potential of test substance and its structurally and functionally similar read across substances were observed in various studies. From the results obtained from these studies it is concluded that the chemical is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.
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