Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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


Migrated from Short 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.

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


Migrated from Short description of key information:
Human case studies indicated that dipotassium persulfate may induce respiratory tract sensitization in occupationally exposed individuals. Additional human studies were available for substances of the Persulfate Category, diammonium persulfate and disodium persulfate.

Justification for classification or non-classification

Substances of the Persulfate Category were classified as sensitising, R 42/43 (may cause sensitisation by inhalation and skin contact) according to Directive 67/548/EEC(DSD), and 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).