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Administrative data

Description of key information

Dipotassium persulfate was tested for skin sensitization in a Local Lymph Node Assay (LLNA) revealing skin sensitisation potential. Additionally, using a read across approach from other animal study data from diammonium persulfate and disodium persulfate, dipotassium persulfate was considered skin sensitising. Furthermore, human data indicated skin sensitising potential for dipotassium persulfate.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1 %
No. with + reactions:
14
Total no. in group:
20
Clinical observations:
Erythema; Edema
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1 %
No. with + reactions:
14
Total no. in group:
20
Clinical observations:
Erythema; Edema
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1 %
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
Erythema; Edema
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1 %
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Erythema; Edema
Group:
positive control
Remarks on result:
not measured/tested
Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Dipotassium persulfate was tested for skin sensitising potential in the mouse local lymph node assay (LLNA). Based on the EC3 value, dipotassium persulfate was considered as a moderate skin sensitizer. As all substances of the Persulfate Category share the same anionic persulfate moiety and similar toxicological properties, a read approach was applied using test results from diammonium persulfate and disodium persulfate. Skin sensitisation studies in Guinea pigs (maximisation test) were available for diammonium persulfate and disodium persulfate indicating a skin sensitisation potential. Furthermore, human data (epidemiological studies and case reports) revealed some skin sensitizing potential.

Of the Persulfate Category, diammonium persulfate, dipotassium persulfate and disodium persulfate were tested in animal studies for skin sensitisation. Diammonium persulfate revealed skin sensitisation properties in a Guinea Pig Maximization Test (GPMT) as well as in a local lymph node assay (LLNA). Disodium persulfate revealed skin sensitization properties in a GPMT and in a LLNA. Additionally, human data (epidemiological studies and case reports) revealed skin sensitization potential for diammonium persulfate, dipotassium persulfate and disodium persulfate.

For the Persulfate Category worst-case results and human data were considered for safety assessment:

Skin sensitisation: sensitising

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Results of human data (epidemiological studies and case reports) indicated that dipotassium persulfate may induce respiratory tract sensitisation in occupationally exposed individuals.

Human data was available for diammonium persulfate, dipotassium persulfate and disodium persulfate of the Persulfate Category. Epidemiological studies and case reports showed respiratory sensitisation potential in occupationally exposed individuals for all three salts of the Persulfate Category.

Respiratory sensitisation: sensitising

Justification for classification or non-classification

Substances of the Persulfate Category were classified for skin sensitisation H317 (may cause an allergic skin reaction) and respiratory sensitisation, cat. 1 H334 (may cause allergy or asthma symptoms or breathing difficulties if inhaled) according to Regulation 1272/2008/EC (CLP), as amended for the fifteenth time in Regulation (EU) 2020/1182.