Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin Irritation:
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 not irritating to skin. Hence, by applying the weight of evidence approach, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid can be considered to be not irritating to skin.
Eye Irritation:
Based on the available data for the structurally similar read across chemicals and applying the weight of
evidence approach, it can be concluded that 2,3-bis[(4-methylbenzoyl)oxy]succinic acid will tend to behave in the same manner as that of the read across chemicals. Hence, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid was estimated to be irritating to eyes andit can be further classified under the category “Category 2” as per CLP regulation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- 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: Weigh of evidence approach based on structurally similar chemicals
- Justification for type of information:
- Weigh of evidence approach 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 irritation potential of 2,3-bis[(4-methylbenzoyl)oxy]succinic acid
- GLP compliance:
- not specified
- 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:
- rabbit
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 48 hours
- Number of animals:
- 3
- Details on study design:
- The study is based on weight of evidence approach from the read across values
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- no signs of irritation observed
- Interpretation of results:
- other: not irritating
- 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 not irritating to skin. Hence, by applying the weight of evidence approach, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid can be considered to be not irritating 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 irritation potential of 2,3-bis[(4-methylbenzoyl)oxy]succinic acid.
Skin irritation effects were estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for2,3-bis[(4-methylbenzoyl)oxy]succinic acid. Based on estimation, no severe skin irritation effects were known when2,3-bis[(4-methylbenzoyl)oxy]succinic acid was exposed to rabbit skin.Hence,2,3-bis[(4-methylbenzoyl)oxy]succinic acid can be considered not irritating to skin.
This estimated result is supported by an experimental study performed to assess the dermal irritation potential of the structurally similar chemical. 0.5 ml of 1.8% aqueous solution was applied under occlusion to the clipped skin of 3 Japanese White rabbits for 24 hours. The treated skin was observed at 1, 24 and 48 hours. No signs of irritation were observed. The Draize score was 0.
Hence, the test chemical was considered to be not irritating to skin.
These results are further supported by the experimental study performed for another structurally similar chemical. 6 Japanese White rabbits were used for the study.
Erythema was observed at two animals out of six. At one animal, it was observed on the intact skin and the abraded skin. At the other animal, it was done on the only abraded skin. The erythema on the intact skin observed at 24 hrs got disappeared at 48 hrs. No more abnormality was observed during 7 days observation. The PDII was calculated to be 0.1.
The substance was considered to be not irritating to skin.
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 not irritating to skin. Hence, by applying the weight of evidence approach, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid can be considered to be not irritating to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- 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 structrurally similar read across chemicals
- Justification for type of information:
- Weight of evidence based on structrurally similar read across 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 based on structrurally similar read across 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 ocular irritation potential of 2,3-bis[(4-methylbenzoyl)oxy]succinic acid
- GLP compliance:
- not specified
- 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:
- rabbit
- Strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- 48 and 72 hours
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The study is based on weight of evidence approach from the read across values
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Signs of irritation observed
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the available data for the structurally similar read across chemicals and applying the weight of
evidence approach, it can be concluded that2,3-bis[(4-methylbenzoyl)oxy]succinic acid will tend to behave in the same manner as that of the read across chemicals. Hence, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid was estimated to be irritating to eyes andit can be further classified under the category “Category 2” as per CLP regulation. - Executive summary:
Based on the available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the ocular irritation potential of2,3-bis[(4 -methylbenzoyl)oxy]succinic acid.
The primary eye irritation potential of the structurally similar chemical was evaluated according to Draize method. 3 female Japanese White rabbits (2.0-2.2 kg) were used for the study. The chemical (if solid= 100 mg, if liquid = 0.1ml) was instilled into the conjunctival sac of the left eye. Right eye (untreated eye) served as blank control. The eyes were examined and the grade of ocular lesions was recorded at 1, 24, 48, 72, 96 hours and 7, 14, 21 days after administration of test chemical. Corneal opacity, erythema, chemosis, secreta and iritis were recorded and classified under Draize method (Draize et.al, 1944)
The sum of values, recorded for cornea, conjunctiva and iris was divided by the number of observation times and the average scores (Draize scores) were used as grades of ocular irritation potential of the chemical. The maximum value of Draize score are as follows: Cornea =80, Conjunctiva = 20 and Iris = 5
The average Draize scores after 21 days were as follows: CORNEA = 33.9/80, iris = 0.6, conjunctiva = 5.1.
The test chemical caused moderate eye irritation recovering within 21 days of treatment.
Hence, the test chemical can be considered irritating to eyes.
This is supported by the results of other ocular irritation study performed on rabbits to determine the degree of irritation caused by the other structurally similar read across chemical. 0.1 ml of 1.8% aqueous solution was administered into one eye of 3 Japanese White rabbits. The eyes were observed at1, 24 and 48 hours. Signs of irritation were observed. The maximum total score was 2. Hence, the test chemical was considered to be irritating to eyes.
The above studies are further supported by the results of another ocular irritation study performed on rabbits to determine the degree of irritation caused by the another structurally similar read across chemical. Undiluted test chemical was instilled into the eyes of 3 rabbits and observed for effects. The treated eyes remained unwashed and Fluorescein staining was done to observe the extent of corneal damage, adnexal staining in the treated unwashed eyes.
Iritis and corneal staining were observed in one of three rabbits while adnexal staining was observed in the other two. Slight to moderate irritation was observed in the rabbit eyes when the treated eyes remained unwashed. Prompt irrigation of three additional eyes had a palliative effect.
Overall, the test chemical was considered to be a moderate eye irritant when tested in 3 unwashed eyes.
Based on the available data for the structurally similar read across chemicals and applying the weight of
evidence approach, it can be concluded that2,3-bis[(4-methylbenzoyl)oxy]succinic acid will tend to behave in the same manner as that of the read across chemicals. Hence, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid was estimated to be irritating to eyes andit can be further classified under the category “Category 2” as per CLP regulation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
Based on the available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the skin irritation potential of 2,3-bis[(4-methylbenzoyl)oxy]succinic acid.
Skin irritation effects were estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for2,3-bis[(4-methylbenzoyl)oxy]succinic acid. Based on estimation, no severe skin irritation effects were known when2,3-bis[(4-methylbenzoyl)oxy]succinic acid was exposed to rabbit skin.Hence,2,3-bis[(4-methylbenzoyl)oxy]succinic acid can be considered not irritating to skin.
This estimated result is supported by an experimental study performed to assess the dermal irritation potential of the structurally similar chemical. 0.5 ml of 1.8% aqueous solution was applied under occlusion to the clipped skin of 3 Japanese White rabbits for 24 hours. The treated skin was observed at 1, 24 and 48 hours. No signs of irritation were observed. The Draize score was 0.
Hence, the test chemical was considered to be not irritating to skin.
These results are further supported by the experimental study performed for another structurally similar chemical. 6 Japanese White rabbits were used for the study.
Erythema was observed at two animals out of six. At one animal, it was observed on the intact skin and the abraded skin. At the other animal, it was done on the only abraded skin. The erythema on the intact skin observed at 24 hrs got disappeared at 48 hrs. No more abnormality was observed during 7 days observation. The PDII was calculated to be 0.1.
The substance was considered to be not irritating to skin.
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 not irritating to skin. Hence, by applying the weight of evidence approach, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid can be considered to be not irritating to skin.
Eye Irritation:
Based on the available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the ocular irritation potential of2,3-bis[(4 -methylbenzoyl)oxy]succinic acid.
The primary eye irritation potential of the structurally similar chemical was evaluated according to Draize method. 3 female Japanese White rabbits (2.0-2.2 kg) were used for the study. The chemical (if solid= 100 mg, if liquid = 0.1ml) was instilled into the conjunctival sac of the left eye. Right eye (untreated eye) served as blank control. The eyes were examined and the grade of ocular lesions was recorded at 1, 24, 48, 72, 96 hours and 7, 14, 21 days after administration of test chemical. Corneal opacity, erythema, chemosis, secreta and iritis were recorded and classified under Draize method (Draize et.al, 1944)
The sum of values, recorded for cornea, conjunctiva and iris was divided by the number of observation times and the average scores (Draize scores) were used as grades of ocular irritation potential of the chemical. The maximum value of Draize score are as follows: Cornea =80, Conjunctiva = 20 and Iris = 5
The average Draize scores after 21 days were as follows: CORNEA = 33.9/80, iris = 0.6, conjunctiva = 5.1.
The test chemical caused moderate eye irritation recovering within 21 days of treatment.
Hence, the test chemical can be considered irritating to eyes.
This is supported by the results of other ocular irritation study performed on rabbits to determine the degree of irritation caused by the other structurally similar read across chemical. 0.1 ml of 1.8% aqueous solution was administered into one eye of 3 Japanese White rabbits. The eyes were observed at1, 24 and 48 hours. Signs of irritation were observed. The maximum total score was 2. Hence, the test chemical was considered to be irritating to eyes.
The above studies are further supported by the results of another ocular irritation study performed on rabbits to determine the degree of irritation caused by the another structurally similar read across chemical. Undiluted test chemical was instilled into the eyes of 3 rabbits and observed for effects. The treated eyes remained unwashed and Fluorescein staining was done to observe the extent of corneal damage, adnexal staining in the treated unwashed eyes.
Iritis and corneal staining were observed in one of three rabbits while adnexal staining was observed in the other two. Slight to moderate irritation was observed in the rabbit eyes when the treated eyes remained unwashed. Prompt irrigation of three additional eyes had a palliative effect.
Overall, the test chemical was considered to be a moderate eye irritant when tested in 3 unwashed eyes.
Based on the available data for the structurally similar read across chemicals and applying the weight of
evidence approach, it can be concluded that 2,3-bis[(4-methylbenzoyl)oxy]succinic acid will tend to behave in the same manner as that of the read across chemicals. Hence, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid was estimated to be irritating to eyes andit can be further classified under the category “Category 2” as per CLP regulation.
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 not irritating to skin and but causes irritation to eyes.
Hence by applying the weight of evidence approach, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid can be considered to be not irritating to skin and irritating to eyes. It can be classified under the category “Not Classified” for skin irritation and “Category 2” for eye irritation as per CLP regulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.