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EC number: 299-370-6 | CAS number: 93859-32-6
Endpoint summary
Administrative data
Description of key information
Prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound Sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2,3-dihydro-1,3-benzoxazole-2-sulfonat... (93859-32-6).The study assumed the use of male and female Wistar rats in chronic study of 24month. No significant alterations were noted at the dose level of 675.20mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for Sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2 ,3-dihydro-1,3 benzoxazol-2-sulfonat... (93859-32-6) is considered to be 675.20mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 675.2 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- K2 data form OECD QSAR 3.3 version
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose oral toxicity:
Prediction model based estimation and data available for the target chemical was reviewed to determine the toxic nature of Sodium 2-[7-(diethylamino)- 2-oxo-2H-chromen-3-yl]- 5-sulfamoyl-2,3-dihydro-1,3-benzoxazole-2-sulfonat... (93859-32-6) upon repeated exposure by oral, dermal and inhalation route of exposure. The studies are as mentioned below:
Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound Sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2,3-dihydro-1,3-benzoxazole-2-sulfonat... (93859-32-6).The study assumed the use of male and female Wistar rats in chronic study of 24month. No significant alterations were noted at the dose level of 675.20mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for Sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2 ,3-dihydro-1,3 benzoxazol-2-sulfonat... (93859-32-6) is considered to be 675.20mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.
Other Repeated dose toxicity study was performed by D. E. Hall et al.( Fd Cosmet. Toxicol,1967) to determine the oral toxic nature Blue VRS; IUPAC name; sodium 4-{[4-(diethylamino)phenyl][4-(diethyliminio)cyclohexa-2,5-dien-1-ylidene]methyl}benzene-1,3-... (129-17-9). The data is taken from Read across substance. The read across substance share a high similarity in structure. So it is acceptable to tale data from analogous structure. In a Chronic repeated dose toxicity study, SPF Carworth Farm E male and female rats were treated with Blue VRS at a concentration of 0.0, 0.3, 0.75, 1.5 and 3.0 % (0, 150, 375, 750 and 1500 mg/kg/day) orally. Impairment of growth, Reduction in food consumption, compound intake and bluish-green and slightly more acid urine were observed in 1.5 and 3.0 % treated male and female as compared to control. In addition, Fatty changes in the liver of female rat and increase number of active acini in the thyroids of male rat of 1.5 and 3.0 % treated animals. Blue material in the lumen of convoluted tubules associated with a coloured line observed at the cortcomedullary junction of kidney in male of 3.0 % treated dose groups but this was not necessarily attributable to Blue VRS. Histological changes associated with acinal activity occur in response to stress of various kinds were noted. Therefore, the no observed adverse effect level (NOAEL) was considered to be 375 mg/kg/day (0.75 %) when SPF Carworth Farm E male and female rats were treated with Blue VRS orally for 90 days.
Another Repeated dose toxicity study was performed by J. F. BORZELLECA et al.( Fd Chem. Toxic.,1985) to determine the oral toxic nature indigo carmine; IUPAC name; disodium 3,3'-dioxo-1,1',3,3'-tetrahydro-2,2'-biindole-5,5'-disulfonate (860-22-0). The data is taken from Read across substance. The read across substance share a high similarity in structure. So it is acceptable to tale data from analogous structure. In a chronic toxicity study,charles river CD male and female rats treated with Indigo carmine in dose concentration of 250 mg/kg bw, 500 mg/kg bw and 1000 mg/kg bw for F0 generation and 304mg/kg/day (0.5%), 632mg/kg/day (1.0%) and 1282 mg/kg/day (2.0%) and 363, 775 and 1592 mg/kg/day male and female For F1 generation respectively.The study was conducted in two phase utero phase and Chronic feeding phase.No effects were observed on survival, body weight, hematology and organ weights of treated male and female rats. In addition, no gross pathologyical and histopathological effect was observed in treated rats as compared to control. Hence, NOAEL was considered to be be 1000 mg/kg for F0 generation of Charles river male and female rats when they were treated with Indigo carmine orally in diet for 30 months.
Repeated inhalation study:
According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance Sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2,3-dihydro-1,3-benzoxazole-2-sulfonat... (93859-32-6), which is reported as 2.92E-019 Pa at 25 C. Also considering the particle size distribution of the substance the majority of the particles was found to be in the size of 150 to 10 micron which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical Sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2,3-dihydro-1,3-benzoxazole-2-sulfonat... is highly unlikely. Therefore this study is considered for waiver.
Repeated dermal study
The acute toxicity value for Sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2,3-dihydro-1,3-benzoxazole-2-sulfonat... (93859-32-6) (as provided in section 7.2.3) is 29969.0mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that Sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2,3-dihydro-1,3-benzoxazole-2-sulfonat...shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2,3-dihydro-1,3-benzoxazole-2-sulfonat...shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
Based on the data available for the target chemical and its prediction, Sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2,3-dihydro-1,3-benzoxazole--sulfonat... (93859-32-6) does not exhibit toxic nature upon repeated exposure by oral, inhalation and dermal route of exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.
Justification for classification or non-classification
Based on the data available for the target chemical and its read across,Sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2,3-dihydro-1,3-benzoxazole-2-sulfonat... (93859-32-6) does not exhibit toxic nature upon repeated exposure by oral, inhalation and dermal route of exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.
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