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Description of key information

Dipotassium persulfate was tested for repeated dose toxicity in rats in a 28-day study. A NOAEL value of 131.5 was determined. Additional repeated dose toxicity studies were available for substances of the Persulfate Category. For diammonium persulfate and disodium persulfate a NOAEL of 91 mg/kg bw/day for subchronic oral toxicity and a NOAEC of 10.3 mg/m³ for subchronic inhalation toxicity, respectively, were determined. Repeated dose toxicity via the dermal route was waived, but a NOEAL calculated for chemical risk assessment resulting in a dermal NOAEL of 91 mg/kg bw/day assuming 100 % absorption through the skin.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
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
Dose descriptor:
NOAEL
Effect level:
103.3 mg/kg bw/day (nominal)
Based on:
other: recalculated for KPS
Sex:
male/female
Basis for effect level:
body weight and weight gain
food consumption and compound intake
Key result
Critical effects observed:
no
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
131.5 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic 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
Dose descriptor:
NOAEC
Effect level:
10.3 mg/m³ air
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
mortality
body weight and weight gain
food consumption and compound intake
ophthalmological examination
haematology
clinical biochemistry
urinalysis
organ weights and organ / body weight ratios
gross pathology
histopathology: non-neoplastic
Key result
Dose descriptor:
NOEC
Effect level:
5 mg/m³ air
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
mortality
body weight and weight gain
food consumption and compound intake
ophthalmological examination
haematology
clinical biochemistry
urinalysis
organ weights and organ / body weight ratios
gross pathology
histopathology: non-neoplastic
Key result
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
10.3 mg/m³
Study duration:
subchronic
Experimental exposure time per week (hours/week):
30
Species:
rat

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Dipotassium persulfate was tested for repeated dose toxicity in rats in a subacute 28-day study. There were no mortalities. A NOAEL value of 131.5 mg/kg bw/day was revealed. As all substances of the Persulfate Category share the same anionic persulfate moiety and similar toxicological properties, a read across approach was used from data available for diammonium persulfate and disodium persulfate to dipotassium persulfate.

Of the Persulfate Category diammonium persulfate, dipotassium persulfate and disodium persulfate were tested for oral repeated dose toxicity. Diammonium persulfate was tested for subacute oral toxicity in rats in a 28-day study. A NOAEL of 41.1 mg/kg bw/day was determined. The apparent difference in subacute toxicity of persulfates was considered to be due to the ammonium cation and its effects. Diammonium persulfate, when dissociated in solution, exists as simple alkali metal cation and persulfate anion, with the ammonium cation in equilibrium with ammonia depending on the solution’s pH. Dissolution of ammonium persulfate itself will also affect pH. This may complicate the toxicological profile of ammonium persulfate (EC JRC IHCP Report, 2007). Disodium persulfate was tested for subchronic repeated dose oral toxicity in rats in a 90-day study. A NOAEL 91 mg/kg bw/day was determined. Diammonium persulfate was tested for subchronic inhalation toxicity and a NOAEC value of 10.3 mg/m³ was determined. Repeated dose toxicity via the dermal route was waived, but a NOEAL calculated for chemical risk assessment resulting in a dermal NOAEL of 91 mg/kg bw/day assuming 100 % absorption through the skin.

Worst-case values considered for safety assessment were:

Repeated dose oral (NOAEL): 91 mg/kg bw/day

Repeated dose inhalation (NOAEC): 10.3 mg/m³/day

Repeated dose dermal (NOAEL): 91 mg/kg bw/day

Justification for classification or non-classification

Based on the results obtained, substances of the Persulfate Category were not classified and labelled for repeated dose toxicity according to Regulation 1272/2008/EC (CLP), as amended for the fifteenth time in Regulation (EU) 2020/1182.