Registration Dossier

Administrative data

Description of key information

Dipotassium persulfate was tested for acute toxicity via the oral, dermal and inhalation routes. In an acute oral toxicity study a LD50 value of 1130 mg/kg bw was determined. In an acute dermal toxicity study LD50 and LD0 values of greater than 10000 mg/kg bw and 10000 mg/kg bw, respectively, were determined. In an acute inhalation toxicity study LC50 and LC0 values of greater than 42.9 mg/L and 42.9 mg/L, respectively, were revealed. Additional studies were available for substances of the Persulfate Category, diammonium persulfate and disodium persulfate.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
READ ACROSS CATEGORY APPROACH
A category group was formed with dipotassium peroxodisulphate (KPS), disodium peroxodisulphate (SPS) and diammonium peroxodisulphate (APS). Several physico-chemical, fate, ecotoxicological and toxicological endpoints were assessed using the category approach. Please refer to the read across justification in chapter 13 for further information.
Reason / purpose:
read-across source
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
742 mg/kg bw
95% CL:
>= 237 - <= 1 247
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
700 mg/kg bw
95% CL:
>= 502 - <= 898
Sex:
male
Dose descriptor:
LD0
Effect level:
300 mg/kg bw
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 130 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
READ ACROSS CATEGORY APPROACH
A category group was formed with dipotassium peroxodisulphate (KPS), disodium peroxodisulphate (SPS) and diammonium peroxodisulphate (APS). Several physico-chemical, fate, ecotoxicological and toxicological endpoints were assessed using the category approach. Please refer to the read across justification in chapter 13 for further information.
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 2.95 mg/L air (analytical)
Exp. duration:
4 h
Sex:
male/female
Dose descriptor:
LC0
Effect level:
2.95 mg/L air (analytical)
Exp. duration:
4 h
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
42 900 mg/m³

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
READ ACROSS CATEGORY APPROACH
A category group was formed with dipotassium peroxodisulphate (KPS), disodium peroxodisulphate (SPS) and diammonium peroxodisulphate (APS). Several physico-chemical, fate, ecotoxicological and toxicological endpoints were assessed using the category approach. Please refer to the read across justification in chapter 13 for further information.
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 000 mg/kg bw

Additional information

Dipotassium persulfate was tested for acute toxicity via the oral, dermal and inhalation routes. In an acute oral toxicity study in male rats a LD50 value of 1130 mg/kg bw was determined. In an acute dermal toxicity study in male rabbits LD50 and LD0 values of greater than 10000 mg/kg bw and 10000 mg/kg bw were determined respectively. In an acute inhalation toxicity study in male rats LC50 and LC0 values of greater than 42.9 mg/L and 42.9 mg/L, respectively, were determined.

Of the Persulfate Category, diammonium persulfate and disodium persulfate were tested as well for acute oral, acute dermal and acute inhalation toxicity. In acute oral toxicity studies the LD50 value for diammonium persulfate was 742 mg/kg bw in the male rat and 700 mg/kg bw in the female rat and an LD0 value of 300 mg/kg bw in male rats. LD50 and LD0 values of 895 mg/kg bw and 500 mg/kg bw were determined for disodium persulfate.

The LD50 and LD0 values determined in an acute dermal toxicity in rat for diammonium persulfate were greater than 2000 mg/kg bw and 2000 mg/kg bw, respectively. For disodium persulfate LD50 and LD0 values of 10000 mg/kg bw and 10000 mg/kg bw, respectively were determined in an acute dermal toxicity in rabbit.

In acute inhalation studies, the LC50 and LC0 values for diammonium persulfate were greater than 2.95 mg/L and 2.95 mg/L, respectively. For disodium persulfate LC50 and LC0 values of greater than 5.1 mg/L and 5.1 mg/L, respectively were determined.

For the Persulfate Category worst-case values obtained were considered for safety assessment:

LD0 (oral): 300 mg/kg bw

LD0 (dermal): 2000 mg/kg bw

LC0 (inhalation): 2950 mg/m³.

Justification for classification or non-classification

Based on the results obtained, substances of the Persulfate Category were classified and labelled acute toxic, cat. 4 H302 (harmful if swallowed) according to Regulation (EC) No 1272/2008, as amended for the fifteenth time in Regulation (EU) 2020/1182.