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EC number: 251-132-2 | CAS number: 32634-68-7
- 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
The experimental results for the read across chemicals lend ample support to the results obtained from the estimation for the target chemical, affirming that 2,3-bis[(4-methylbenzoyl)oxy]succinic acid can indeed be sensitizing to skin. Hence, by applying the weight of evidence approach, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid can be considered to be sensitizing to skin.
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:
- other: Weight of evidence based on structurally similar chemicals
- Justification for type of information:
- Weight of evidence based on structurally similar chemicals
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- other: Weight of evidence approach based on structurally similar chemicals
- Principles of method if other than guideline:
- The weight of evidence report has been prepared based on the read across substances identified based on structural and functional similarity to assess the dermal sensitization potential of 2,3-bis[(4-methylbenzoyl)oxy]succinic
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence approach based on structurally similar chemicals
- Specific details on test material used for the study:
- - Name of test material: 2,3-bis[(4-methylbenzoyl)oxy]succinic acid
- IUPAC name: (+)-Di-p-toluoyl-D-tartaric Acid
- Molecular formula: C20H18O8
- Molecular weight: 386.3542 g/mole
- Smiles : Cc1ccc(cc1)C(=O)O[C@@H]([C@H](OC(=O)c2ccc(C)cc2)C(=O)O)C(=O)O
- Inchl: 1S/C20H18O8/c1-11-3-7-13(8-4-11)19(25)27-15(17(21)22)16(18(23)24)28-20(26)14-9-5-12(2)6-10-14/h3-10,15-16H,1-2H3,(H,21,22) (H,23,24)/t15-,16-/m0/s1
- Substance type: Organic
- Physical state: Solid powder (white) - Species:
- other: guinea pigs and humans
- Strain:
- not specified
- Sex:
- male/female
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- The study is based on weight of evidence approach from the read across values
- Details on study design:
- The study is based on weight of evidence approach from the read across values
- Challenge controls:
- The study is based on weight of evidence approach from the read across values
- Reading:
- 1st reading
- Group:
- test chemical
- Clinical observations:
- signs of dermal sensitization observed
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- other: sensitizer
- Conclusions:
- The experimental results for the read across chemicals lend ample support to the results obtained from the estimation for the target chemical, affirming that 2,3-bis[(4-methylbenzoyl)oxy]succinic acid can indeed be sensitizing to skin. Hence, by applying the weight of evidence approach, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid can be considered to be sensitizing to skin.
- Executive summary:
Based on the available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the skin sensitization potential of 2,3-bis[(4-methylbenzoyl)oxy]succinic acid.
Skin sensitization effects were estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for 2,3-bis[(4-methylbenzoyl)oxy]succinic acid. Based on estimation, skin sensitization reactions were observed in guinea pigs and humans. Therefore, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid was considered to be sensitizing.
The estimated result is supported by experimental study performed on humans according to the slight modifications in the method proposed by Draize to determine the allergic potential of the structurally similar chemical. 25 healthy human volunteers, 14 males, 11 females (23 Caucasians and 2 Negroes), aged 19-49 were used in the study. None of the subjects gave positive past history of atopy or contact sensitivity. A single 48 hour application of the test chemical in 50% polystyrene was made to the backs of atleast 10 normal subjects to ensure that concentrations used were non-irritating. In the induction exposure, a small quantity of test material 50% in polystyrene was placed on the wetted central gauze portion of 1.5 inch square J&J BANDAID before application to a non hairy region of the upper back. Dermicel hypoallergic tape was used to occlude, cover and secure the patches. Patches were applied to the same sites on alternate days for 3 weeks, a total of 9 applications. They were left in place for 24 hours and then removed. The subjects were told not to expose their backs to sunlight. Residual powder was gently removed from skin using soft pads wetted with water or 70% alcohol. Challenge exposure was performed on Monday of the 6thweek following a rest period of 14 days. Patches were applied to the untreated sites of the skin of back and were left in situ for 48 hours. Reactions were graded after removal of patches and again at 96 and 144 hours. Also these 10 subjects were challenged with non irritating concentrations of undiluted polystyrene. No significant reactions were observed to the vehicle. Sensitization reactions were observed in 5 of the 10 patients. In some subjects, the challenge reactions were so reactive to necessitate removal of patches before the completion of 48 hour period. Hence, the test chemical was considered to have potential to cause dermal sensitization.
The above results are also supported by another study conducted to determine the allergenic potential of other structurally similar chemical in guinea pigs. The test chemical was applied to the skin of 5 guinea pigs and observed for signs of dermal irritation and sensitization (dose, duration, observation period).The compound was a skin sensitizer in guinea pigs producing a weak response in two animals and a moderate response in two animals. One animal showed no response. Hence, the test chemical was considered to have potential to cause dermal sensitization.
The experimental results for the read across chemicals lend ample support to the results obtained from the estimation for the target chemical, affirming that 2,3-bis[(4-methylbenzoyl)oxy]succinic acid can indeed be sensitizing to skin. Hence, by applying the weight of evidence approach, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid can be considered to be sensitizing to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Based on the available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the skin sensitization potential of2,3-bis[(4-methylbenzoyl)oxy]succinic acid.
Skin sensitization effects were estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for 2,3-bis[(4-methylbenzoyl)oxy]succinic acid. Based on estimation, skin sensitization reactions were observed in guinea pigs and humans. Therefore, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid was considered to be sensitizing.
The estimated result is supported by experimental study performed on humans according to the slight modifications in the method proposed by Draize to determine the allergic potential of the structurally similar chemical. 25 healthy human volunteers, 14 males, 11 females (23 Caucasians and 2 Negroes), aged 19-49 were used in the study. None of the subjects gave positive past history of atopy or contact sensitivity. A single 48 hour application of the test chemical in 50% polystyrene was made to the backs of atleast 10 normal subjects to ensure that concentrations used were non-irritating. In the induction exposure, a small quantity of test material 50% in polystyrene was placed on the wetted central gauze portion of 1.5 inch square J&J BANDAID before application to a non hairy region of the upper back. Dermicel hypoallergic tape was used to occlude, cover and secure the patches. Patches were applied to the same sites on alternate days for 3 weeks, a total of 9 applications. They were left in place for 24 hours and then removed. The subjects were told not to expose their backs to sunlight. Residual powder was gently removed from skin using soft pads wetted with water or 70% alcohol. Challenge exposure was performed on Monday of the 6thweek following a rest period of 14 days. Patches were applied to the untreated sites of the skin of back and were left in situ for 48 hours. Reactions were graded after removal of patches and again at 96 and 144 hours. Also these 10 subjects were challenged with non irritating concentrations of undiluted polystyrene. No significant reactions were observed to the vehicle. Sensitization reactions were observed in 5 of the 10 patients. In some subjects, the challenge reactions were so reactive to necessitate removal of patches before the completion of 48 hour period. Hence, the test chemical was considered to have potential to cause dermal sensitization.
The above results are also supported by another study conducted to determine the allergenic potential of other structurally similar chemical in guinea pigs. The test chemical was applied to the skin of 5 guinea pigs and observed for signs of dermal irritation and sensitization (dose, duration, observation period).The compound was a skin sensitizer in guinea pigs producing a weak response in two animals and a moderate response in two animals. One animal showed no response. Hence, the test chemical was considered to have potential to cause dermal sensitization.
The experimental results for the read across chemicals lend ample support to the results obtained from the estimation for the target chemical, affirming that 2,3-bis[(4-methylbenzoyl)oxy]succinic acid can indeed be sensitizing to skin. Hence, by applying the weight of evidence approach, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid can be considered to be sensitizing to skin.
Justification for classification or non-classification
The results of the experimental studies from the structurally similar read across substances indicate a possibility that 2,3-bis[(4-methylbenzoyl)oxy]succinic acid can be sensitizing to skin.
Hence by applying the weight of evidence approach, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid can be considered to be sensitizing to skin.
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