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Description of key information

LD50 was considered as >22000 mg/kg when rats and mouse were treated with of 5-oxo-1-(4-sulphophenyl)-2-pyrazoline-3-carboxylic acid orally

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from Chemidplus report
Qualifier:
according to guideline
Guideline:
other: The data is from chemid plus
Principles of method if other than guideline:
Acute oral toxicity of chemical Pyrazolone T was determined.
GLP compliance:
not specified
Test type:
other: not reported
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
no data
Doses:
No data available
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
No data available
Statistics:
No data available
Preliminary study:
No data available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 22 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Lethality of test chemical
Mortality:
No data available
Clinical signs:
No data available
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The lethal concentration was found to be >22000 mg/kg in acute oral toxicity test of chemical Pyrazolone T exposed to rat by oral route.
Executive summary:

Acute oral toxicity test was conducted on rat to evaluate the lethargic concentration of chemical Pyrazolone T.

The lethal concentration was found to be >22000 mg/kg in acute oral toxicity test of chemical Pyrazolone T exposed to rat by oral route.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
22 000 mg/kg bw
Quality of whole database:
Data is from Chem ID Plus 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:

Data available for target 5-oxo-1-(4-sulphophenyl)-2-pyrazoline-3-carboxylic acid (118-47-8) and its read across Tartrazine (CAs no 1934-21-0) and 2-Pyrazolin-5-one, 3-methyl-1-ptolyl (CAS no 86-92-0) for acute oral toxicity are summarized as below 

In Chemidplus database (2016), acute oral toxicity was given as >22000 mg/kg when rats and mouse were treated with of 5-oxo-1-(4-sulphophenyl)-2-pyrazoline-3-carboxylic acid. Therefore, LD50 was considered as >22000 mg/kg when rats and mouse were treated with of 5-oxo-1-(4-sulphophenyl)-2-pyrazoline-3-carboxylic acid orally.

Based on prediction done by using QSAR Toolbox version 3.3 (2016), acute oral toxicity was estimated in Wistar male and female rats by using 5-oxo-1-(4-sulphophenyl)-2-pyrazoline-3-carboxylic acid in the concentration of 2000 mg/kg bw orally by gavage and observed for 14 days. 50 % mortality was estimated at 1542.279174805 mg/kg bw. Therefore, estimated LD50 was considered to be 1542.279174805 mg/kg bw when Wistar male and female rats were treated with 5-oxo-1-(4-sulphophenyl)-2-pyrazoline-3-carboxylic acid orally by gavage.   

In a study conducted by Lamiaet al(2016) for read across, acute oral toxicity was evaluated in Sprague-Dawley male mice by using Tartrazine in the concentration of 0, 1250 mg/kg ,2500 mg/kg ,3750 mg/kg ,5000 mg/kg , 6250 mg/kg bw in distilled water orally by gavage and observed for 3 days. No Mortality and signs and symptoms of toxicity were observed in treated mice. Therefore, LD50 was considered to be > 6250 mg/kg bw when Sprague-Dawley male mice were treated with Tartrazine orally by gavage.

In a study conducted by Sasakiet al(2002) and study report given by Feinman et al (1981) for read across, acute oral toxicity was evaluated in ddY male mice by using Tartrazine in the concentration of 2000 mg/kg bw in physiological saline orally. No Mortality was observed in treated mice. Therefore, LD50 was considered to be > 2000 mg/kg bw when ddY male mice were treated with Tartrazine orally.

In a RTECS database (2016) for read across, acute oral toxicity given for rats by using 2-Pyrazolin-5-one, 3-methyl-1-ptolyl in the concentration of 7450 mg/kg bw. 50 % mortality and behavioural somnolence (general Depressed activity) Skin and Appendages hair was observed in treated rats. Therefore, LD50 was considered to be 7450 mg/kg when rats were treated with 2-Pyrazolin-5-one, 3-methyl-1-ptolyl.

Thus, based on weight of evidence approach from above data for target 5-oxo-1-(4-sulphophenyl)-2-pyrazoline-3-carboxylic acid (118-47-8) and its read across Tartrazine (CAs no 1934-21-0) and 2-Pyrazolin-5-one, 3-methyl-1-ptolyl (CAS no 86-92-0) is likely to classified as non hazardous as per the criteria of CLP regulation.

Justification for selection of acute toxicity – oral endpoint
Acute oral toxicity test was conducted on mouse to evaluate the lethargic concentration of chemical Pyrazolone T.
The lethal concentration was found to be >22000 mg/kg in acute oral toxicity test of chemical Pyrazolone T exposed to mouse by oral route.

Justification for classification or non-classification

On the basis of available information, the substance Pyrazolone T is not expected to be acutely toxic by oral route.