Diammonium peroxodisulphate

Carcinogenicity

Description of key information

Diammonium persulfate of the Persulfate Category was tested for its skin carcinogenic potential in a 51 week dermal study with mice following a guideline similar to OECD guideline no 451. Based on the data obtained, diammonium persulfate was not considered carcinogenic.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no study available

Study duration:

chronic

Species:

mouse

Carcinogenicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Carcinogenicity: via dermal route

Link to relevant study records

Reference

Endpoint:

carcinogenicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-05-15

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 451 (Carcinogenicity Studies)

Principles of method if other than guideline:

Six oxidizing chemicals were tested for promoting and complete carcinogenic activities in skin carcinogenesis using female Sencar mice. In the promotion tests, the chemicals were applied twice a week for 51 weeks after initiation with dimethylbenzanthracene (DMBA). In the tests for complete
carcinogenic activities, the chemicals alone were applied for 51 weeks.

GLP compliance:

not specified

Species:

mouse

Strain:

Sencar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Shizuoka Laboratory Center; Shizuoka, Japan
- Age at study initiation: 4 weeks
- Weight at study initiation: not indicated
- Fasting period before study: not indicated
- Housing: 5 to a plastic hanging cage
- Diet: rodent diet ad libitum
- Water: ad libitum
- Acclimation period: 2 week


ENVIRONMENTAL CONDITIONS
- Temperature: 24 ± 1 °C
- Humidity: 55 ± 5 %
- Air changes: not indicated
- Photoperiod: not indicated

Route of administration:

dermal

Vehicle:

acetone

Details on exposure:

To test the complete carcinogenic activity, chemicals or acetone only were given topically for 51 weeks. All chemicals were dissolved or diluted in acetone and 0.2 mL was applied to the dorsal skin by automatic pipette twice weekly. The number and diameter of all skin tumours were recorded weekly and body weight was measured monthly. The back of the mice was shaved once a week. At autopsy, the skin and major organs were fixed in 10 % buffered formalin and stained with hematoxylin and eosin. The doses for the experiment were determined on the basis of a subacute skin toxicity test for 4 weeks.

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

52 weeks

Frequency of treatment:

twice weekly

Dose / conc.:

200 other: mg/mL

Remarks:

Basis: nominal conc.

No. of animals per sex per dose:

20 animals

Control animals:

no

Details on study design:

To test the complete carcinogenic activity, chemicals or acetone only were given topically for 51 weeks. All chemicals were dissolved or diluted in acetone and 0.2 mL was applied to the dorsal skin by automatic pipette twice weekly. The number and diameter of all skin tumours were recorded weekly and body weight was measured monthly. The back of the mice was shaved once a week. At autopsy, the skin and major organs were fixed in 10 % buffered formalin and stained with hematoxylin and eosin. The doses for the experiment were determined on the basis of a subacute skin toxicity test for 4 weeks.

Positive control:

For the promotion test: 12-O-tetradecanoyl-phorbol-13-acetate (TPA).

Observations and examinations performed and frequency:

The number and diameter of all skin tumours were recorded weekly and body weight was measured monthly. The back of the mice was shaved once a week.

Sacrifice and pathology:

At autopsy, the skin and major organs were fixed in 10% buffered formalin and stained with hematoxylin and eosin.

Statistics:

Data were analyzed statistically by Fisher’s exact probability test and/or the chi-square test.

Clinical signs:

not specified

Mortality:

not specified

Body weight and weight changes:

not specified

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

effects observed, treatment-related

Histopathological findings: non-neoplastic:

effects observed, treatment-related

Histopathological findings: neoplastic:

effects observed, treatment-related

Details on results:

Only a few skin tumours were noticed in the mice applied with diammonium persulfate.

Relevance of carcinogenic effects / potential:

From a 51 week dermal study in female Sencar mice exposed to 0.2 mL of a 200 mg/mL solution of diammonium persulfate it could be concluded that diammonium persulfate is neither a tumour promoter nor a complete carcinogen when applied to the skin.

Key result

Dose descriptor:

NOAEL

Sex:

female

Remarks on result:

not determinable

Remarks:

no NOAEL identified.

Conclusions:

It is concluded that diammonium persulfate is neither a tumour promoter nor a complete carcinogen when applied to the skin.

Executive summary:

Diammonium persulfate was tested for carcinogenic properties in a 51 week dermal study with female Sencar mice. The animals were exposed to 0.2 mL of a 200 mg/mL solution of diammonium persulfate in acetone. The test item was applied twice weekly to the shaved dorsum of the animals and results in week 13, 26, 38, and 51 were notified for diammonium persulfate treated group and for the control group (acetone). No significant difference was observed between the test substance treated group and the control group. Based on the obtained results diammonium persulfate was considered neither a tumour promoter nor a carcinogen when applied to the skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Study duration:

chronic

Species:

mouse

Justification for classification or non-classification

The available data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based in the available data  substances of the Persulfate Category were not classified and labelled as carcinogenic according to Regulation (EC) No 1272/2008, as amended for the fifteenth time in Regulation (EU) No 2020/1182.

Additional information

Diammonium persulfate of the Persulfate Category was tested for its skin carcinogenic potential in a 51 week dermal study with female Sencar mice following a guideline similar to OECD guideline no. 451. In the study animals were exposed to 0.2 mL of a 200 mg/mL solution of diammonium persulfate in acetone. The test substance was applied twice a week to the shaved dorsum of the animals. Results in week 13, 26, 38, and 51 were notified for the diammonium persulfate treated group and the for the control group (acetone). No significant difference was observed between the test substance treated group and the control group. Based on the obtained results diammonium persulfate was considered neither a tumor promoter nor a carcinogen when applied to the skin.

Of the Persulfate Category, diammonium persulfate was tested for skin carcinogenicity potential. Based on the obtained results in a 52 week dermal study in mice, diammonium persulfate was not considered to be tumour promoter or a carcinogen when applied to the skin. As all substances of the Persulfate Category share the same anionic persulfate moiety and similar toxicological properties a read across was applied for dipotassium persulfate and disodium persulfate using results obtained with diammonium persulfate. No carcinogenesis potential was assumed for dipotassium persulfate and disodium persulfate.