Registration Dossier

Administrative data

Description of key information

Dipotassium persulfate was tested for skin and eye irritation. In the skin irritation study, dipotassium persulfate was found not irritating to the skin. In the eye irritation study, dipotassium persulfate was found to be slightly irritating to the rabbit eye. Human case studies indicated that dipotassium persulfate causes eye irritation. Additional studies were available for substances of the Persulfate Category, diammonium persulfate and disodium persulfate. Using a read across approach from data available for diammonium persulfate, dipotassium persulfate was considered a respiratory tract irritant. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
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
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 2 weeks
Remarks on result:
other: test was performed on scarified skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.89
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: test was performed on scarified skin
Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
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
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
no indication of irritation
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

All substances of the Persulfate category share the same anionic persulfate moiety and similar toxicological properties. Diammonium persulfate, dipotassium persulfate and disodium persulfate were tested in animal studies for skin irritation/corrosion and eye irritation and diammonium persulfate was examined for respiratory irritation in a subchronic inhalation toxicity study. Additionally, human data was available for dipotassium persulfate and diammonium persulfate. Dipotassium persulfate was tested for skin irritation in rabbits. The test material was applied in a single application to the intact and abraded skin of six rabbits each. No signs of irritation/corrosion were observed. In contrast to animal studies, human case studies revealed skin sensitisation properties. Dipotassium persulfate was tested for eye irritation/corrosion in rabbits. Slight irritation effects, which were fully reversible within 24 hours were observed in two of the eight test animals. In humans, one case of corneal burns from dipotassium persulfate was reported and irritant effects of persulfates may cause pain in the eyes with conjunctivitis. Using a read across approach from data available for diammonium persulfate, dipotassium persulfate was considered a respiratory tract irritant. For the Persulfate Category worst-case results were considered for safety assessment:

Skin irritation: irritating

Eye irritation: irritating

Respiratory irritation: irritating

Justification for classification or non-classification

Based on animal test results and human case study data, substances of the Persulfate Category were classified and labelled as eye irritant, cat. 2 H319 (causes serious eye irritation), skin irritant cat. 2 H315 (causes skin irritation) and respiratory tract irritant cat. 3 STOT SE. 3 H335 (causes respiratory tract irritation) according to Regulation (EC) No 1272/2008, as amended for the fifteenth time in Regulation (EU) 2020/1182.