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EC number: 231-786-5 | CAS number: 7727-54-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Carcinogenicity
Administrative data
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
- 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.
Reference
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.
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