Registration Dossier

Diss Factsheets

Administrative data

Description of key information

1, 2-Benzenedicarboxylic acid, monopotassium salt (CAS no 877-24-7) is likely to be non hazardous by oral route of exposure.

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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from authoritative database
Qualifier:
according to guideline
Guideline:
other: as below
Principles of method if other than guideline:
Acute oral toxicity study of 1,2-Benzenedicarboxylic acid, monopotassium salt in rats
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Specific details on test material used for the study:
Name: 1,2-Benzenedicarboxylic acid, monopotassium salt
Molecular Formulas: C8H5O4.K
C8H6O4.K
Molecular Weight: 204.221 g/mole
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data available
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
3200 mg/kg bw
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:
> 3 200 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
No mortality was observed in treated rats at 3200 mg/kg bw
Clinical signs:
other: No data available
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
other: Not Classified
Conclusions:
LD50 was considered to >3200 mg/kg bw when rats were treated with 1,2-Benzenedicarboxylic acid, monopotassium salt orally.
Executive summary:

In a acute oral toxicity study, rats were treated with1,2-Benzenedicarboxylic acid, monopotassium salt in the concentration of 3200 mg/kg bw. No mortality was observed in treated rats at 3200 mg/kg bw.Therefore,LD50 was considered to >3200 mg/kg bw when rats were treated with1,2-Benzenedicarboxylic acid, monopotassium salt orally.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 200 mg/kg bw
Quality of whole database:
Data is Klimischh 2 and from RTECS database and SAX: Chemical Card

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:

Based on the data available for target 1,2-Benzenedicarboxylic acid, monopotassium salt (CAS no 877-24-7) and its read across Phthalic acid (CAS no 88-99-3) is summarized below

In a study given by RTECS database (2017) and SAX: Chemical Card (2012), acute oral toxicity was given for rats by using 1,2-Benzenedicarboxylic acid, monopotassium salt in the concentration of 3200 mg/kg bw. No mortality was observed in treated rats at 3200 mg/kg bw. Therefore, LD50 was considered to >3200 mg/kg bw when rats were treated with 1,2-Benzenedicarboxylic acid, monopotassium salt orally.

Based on the prediction done by using QSAR Toolbox 3.4 (2017), acute oral toxicity was estimated in rats by using potassium biphthalate orally. 50 % mortality was observed at 4447.6 mg/kg bw in treated rats. Therefore, estimated LD50 was considered to be 4447.6 mg/kg bw when rat were treated with potassium biphthalate orally.

Based on the prediction done by using Danish QSAR (2017), acute oral toxicity was estimation done by in mice and rats by using potassium hydrogen phthalate at 2400 and 3500 mg/kg bw orally. 50 % mortality was observed at 2400 and 3500 mg/kg bw. Therefore, estimated LD50 was considered to be 2400 mg/kg bw for mice and 3500 mg/kg bw for rats when mice and rat were treated with potassium hydrogen phthalate orally.

In a study conducted by Schonekeret al(2003) for read across, acute oral toxicity was evaluated in Albino male and female mice by using Phthalic acid in the concentration of 5000 mg/kg bw orally by gavage in 5% gum acacia. No mortality was observed in treated mice at 5000 mg/kg bw. CNS depression and Inflammation of the gastrointestinal tract was observed in treated mice. Therefore, LD50 was considered to >5000 mg/kg bw when Albino male and female mice were treated with Phthalic acid orally by gavage.

Based on the data available for target 1, 2-Benzenedicarboxylic acid, monopotassium salt (CAS no 877-24-7) and its read across Phthalic acid (CAS no 88-99-3) is likely to be non hazardous by oral route of exposure.

Justification for classification or non-classification

Based on the data available for target 1, 2-Benzenedicarboxylic acid, monopotassium salt (CAS no 877-24-7) and its read across Phthalic acid (CAS no 88-99-3) is likely to be non hazardous by oral route of exposure.

Categories Display