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:

Disodium persulfate was tested for skin sensitization in Pirbright White guinea pigs according to OECD guideline 406. In this test, 11 of 20 test animals developed signs of skin sensitization in the test group compare to 1 animal in the control group. Based on the results of the study, disodium persulfate was considered to be a skin sensitizer. Disodium persulfate was tested as well for skin sensitising potential in a mouse local lymph node assay (LLNA). Based on the EC3 value, disodium persulfate was classified as a strong skin sensitizer. In another skin sensitization study in Hartley guinea pigs according to EU guideline B.6 and OECD guideline 406, no signs of skin sensitizing were observed when compared with the control group. In this study, disodium persulfate was not considered sensitizing to skin. Additionally, human data (epidemiological studies and case reports) showed that disodium persulfate is capable of inducing skin sensitisation.

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 Maximization test as well as in a Local Lymph Node Assay (LLNA). Skin sensitisation potential was implied by results of LLNA for dipotassium persulfate. Disodium persulfate revealed skin sensitisation properties in one of the two Guinea pig studies (Maximisation test) and a skin sensitisation potential in a LLNA . Additionally, human data (epidemiological studies and case reports) were available for diammonium persulfate, dipotassium persulfate and disodium persulfate showing skin sensitisation potential in occupationally exposed individuals for all of the three persulfate salts.

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:
Disodium persulfate was tested in two studies examining skin sensitising properties in Guinea pigs and in a Local Lymph Node Assay (LLNA). One of the Guinea-pig studies (maximization-test) and the LLNA indicated of a skin sensitisation potential for disodium persulfate, in contrary to the results observed in the second (supporting) guinea pig study. Thus, based on animal data disodium persulfate was considered to be a skin sensitiser. Furthermore, human data indicated of skin sensitising potential for disodium persulfate. Additional studies were available for substances of the Persulfate Category, diammonium persulfate and 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 disodium persulfate was capable of inducing 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 the three salts of the Persulfate Category. Thus, for the Persulfate Category, for safety assessment:

Respiratory sensitisation: sensitising


Migrated from Short description of key information:
Results from human studies indicated that disodium persulfate was capable of inducing respiratory tract sensitisation in occupationally exposed individuals. Additional human studies were available for substances of the Persulfate Category, dipotassium persulfate and disodium persulfate.

Justification for classification or non-classification

Substances of the Persulfate Category were classified as skin sensitisation H317 (may cause an allergic skin reaction) and respiratoy sensitisation, cat. 1 H334 (may cause allergy or asthma symptoms or breathing difficulties if inhaled) according to Regulation (EC) 1272/2008.