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EC number: 251-132-2 | CAS number: 32634-68-7
Endpoint summary
Administrative data
Description of key information
In Acute oral toxicity,LD50 value for target substance 2,3-bis[(4-methylbenzoyl)oxy]succinic acid (32634-68-7) was considered to be 4100 mg/kg bw in rats and 6200 mg/kg bw in mouse,and for different studies available on functionally similar read across substance was considered to be 6000 mg/kg bw in rats and 4360 mg/kg bw in mouse. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid (32634-68-7)cannot be classified for acute oral toxicity.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Justification for type of information:
- Data is from Danish QSAR
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Prediction is done by using Danish QSAR database
- GLP compliance:
- not specified
- Test type:
- other: Not specified
- Limit test:
- no
- 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:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- Not specified
- Doses:
- 4100 mg/kg bw
- No. of animals per sex per dose:
- Not specified
- Control animals:
- not specified
- Details on study design:
- Not specified
- Statistics:
- Not specified
- Preliminary study:
- Not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 4 100 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality was observed
- Mortality:
- Not specified
- Clinical signs:
- other: Not specified
- Gross pathology:
- Not specified
- Other findings:
- Not specified
- Interpretation of results:
- other: not classified
- Conclusions:
- Based on the QSAR prediction done using the Danish (Q)SAR Database, the LD50 was estimated to be 4100 mg/kg bw on rat for test substance 2,3-bis[(4-methylbenzoyl)oxy]succinic acid (32634-68-7) orally.
- Executive summary:
Based on the QSAR prediction done using the Danish (Q)SAR Database, the LD50 was estimated to be 4100 mg/kg bw on rat for 2,3-bis[(4-methylbenzoyl)oxy]succinic acid (32634-68-7) having Reliability Index: 0.56 (moderate prediction quality).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 100 mg/kg bw
- Quality of whole database:
- Data is Klimisch 2 and from Danish (Q)SAR Database
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute Oral Toxicity:
In different studies, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid (32634-68-7) has been investigated for acute oral toxicity to a greater or lesser extent. Often the studies are based on in vivo experimental data in rodents, i.e. most commonly in rats for 2,3-bis[(4-methylbenzoyl)oxy]succinic acid (32634-68-7) along with the study available on the functionally similar read across substance. The studies are summarized as below –
The study mentioned in Danish (Q)SAR Database (2018) for the target chemical 2,3-bis[(4-methylbenzoyl)oxy]succinic acid (32634-68-7) was for acute oral toxicity. Based on the QSAR prediction done using the Danish (Q)SAR Database, the LD50 was estimated to be 4100 mg/kg bw on rat for 2,3-bis[(4-methylbenzoyl)oxy]succinic acid (32634-68-7) having Reliability Index: 0.56 (moderate prediction quality).
The another study mentioned in Danish (Q)SAR Database (2018) for the target chemical 2,3-bis[(4-methylbenzoyl)oxy]succinic acid (32634-68-7) was for acute oral toxicity. Based on the QSAR prediction done using the Danish (Q)SAR Database, the LD50 was estimated to be 6200 mg/kg bw on mouse for 2,3-bis[(4-methylbenzoyl)oxy]succinic acid (32634-68-7) having Reliability Index: 0.7 ( moderate prediction quality).
Both these studies are again supported with the functionally similar read across substance. Acute oral toxicity study was performed in rats using test chemical.50% mortality was observed at dose 6000 mg/kg bw. Hence,LD50 value was considered to be 6000 mg/kg bw,when rats were treated with test chemical orally.
The above studies were further supported with the another functionally similar read across substance. Acute oral toxicity study was performed in mouse using test chemical.50% mortality was observed at dose 4360 mg/kg bw. Hence,LD50 value was considered to be 4360 mg/kg bw,when mouse were treated with test chemical orally.
Thus, based on the above summarised studies on 2,3-bis[(4-methylbenzoyl)oxy]succinic acid (32634-68-7) and it’s functionally similar read across substance, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid (32634-68-7) cannot be classified for acute oral toxicity.
Justification for classification or non-classification
Based on the above experimental studies on 2,3-bis[(4-methylbenzoyl)oxy]succinic acid (32634-68-7) and it’s functionally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw for acute oral toxicity.Thus, comparing this value with the criteria of CLP regulation, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid (32634-68-7) cannot be classified for acute oral toxicity.
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