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Description of key information

Acute oral toxicity study was done in rat using sulfoacetic acid (123-43-3). LD50 was considered to be 3160 mg/kg body weight.

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 chemidplus and GSBL database.
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Acute oral toxicity study of Sulfoacetic acid was performed in Rat
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 : Sulfoacetic acid
- Molecular formula: C2H4O5S
- Molecular weight : 140.115g/mole
- Substance type:organic
- Physical state:solid
Species:
rat
Strain:
Sherman
Sex:
not specified
Details on test animals or test system and environmental conditions:
- Fasting period before study: Rats were no fasted before experiment.
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
3160 mg/kg
No. of animals per sex per dose:
5 animal /dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
The LD 50 was derived from the course of the curve mortality versus log of the dose graphically determined.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
3 160 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50 % mortality observed
Mortality:
Mortality observed
Clinical signs:
No data available
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Acute oral toxicity study was done in rat using sulfoacetic acid (123-43-3). LD50 was considered to be 3160 mg/kg body weight.
Executive summary:

Acute oral toxicity test was performed in Sherman rats and observed for 14 days. No fasting of rats was done before experiment. 5 animals per dose were given dose by gavage and LD50 was derived from the course of the curve mortality versus log of the Dose graphically determined. After the experiment, the LD 50 value for sulfoacetic acid (123-43-3) was considered to be 3160 mg/kg.

Based on the value, sulfoacetic acid was considered to be non-toxic to rats and can be considered to be “not classified”as per the CLP regulations.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 160 mg/kg bw
Quality of whole database:
Data is Klimicsh 2 and from chemidplus and GSBL 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, sulfoacetic acid (123-43-3).has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments and estimated data in rodents, i.e. most commonly in rats for sulfoacetic acid. The predicted data using the OECD QSAR toolbox has also been compared with the experimental studies.

In experimental study given by U.S. National Library of Medicine (ChemIDplus A TOXNET Database, 2017) and GSBL – Joint Substance Data Pool of the German Federal Government and the German Federal States, 2017. Acute oral toxicity test was performed in Sherman rats and observed for 14 days. No fasting of rats was done before experiment. 5 animals per dose were given dose by gavage and LD50 was derived from the course of the curve mortality versus log of the Dose graphically determined. After the experiment, the LD 50 value for sulfoacetic acid (123-43-3) was considered to be 3160 mg/kg.

In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the acute oral toxicity was estimated for sulfoacetic acid. The LD50 was estimated to be 3160 mg/kg bw when Sprague-Dawley male and female rats were orally exposed with sulfoacetic acid

In another prediction done by SSS (2017) using the Danish QSAR with log kow as the primary descriptor, the acute oral toxicity was estimated for sulfoacetic acid. The LD50 was estimated to be 3800 mg/kg bw in rats (Reliability index: 0.77) orally exposed with sulfoacetic acid.

 

Also it is further supported by experimental study given by U.S. National Library of Medicine (ChemIDplus A TOXNET Database, 2017) on structurally similar read across substance Propionic acid(79 -09 -4), rats were treated with Propionic acid orally. 50% mortality was observed in treated mice at 2600 mg/kg bw. Therefore, LD50 was considered to be 2600mg/kg bw when rats were treated with Propionic acid orally.   

Also it is further supported by experimental study given by U.S. National Library of Medicine (ChemIDplus A TOXNET Database, 2017) on structurally similar read across substance adipic acid(124-04-9)rats were treated with adipic acid orally. No mortality was observed in treated mice at 11000 mg/kg bw. Therefore, LD50 was considered to be > 11000mg/kg bw when rats were treated with adipic acid(124-04-9)orally

 

Thus, based on the above studies and predictions on sulfoacetic acid (123-43-3) and its read across substances, it can be concluded that LD50 value is 3160mg/kg bw. Thus, comparing this value with the criteria of CLP regulation sulfoacetic acid (123-43-3)can be “Not classified” of acute oral toxicity.

 

Justification for classification or non-classification

Thus, based on the above studies and predictions on sulfoacetic acid (123-43-3) and its read across substances, it can be concluded that LD50 value is 3160mg/kg bw. Thus, comparing this value with the criteria of CLP regulation sulfoacetic acid (123-43-3)can be “Not classified” of acute oral toxicity.