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EC number: 231-760-3 | CAS number: 7722-64-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28.3.-28.4.2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test performed before release of OECD 429
Test material
- Reference substance name:
- Potassium permanganate
- EC Number:
- 231-760-3
- EC Name:
- Potassium permanganate
- Cas Number:
- 7722-64-7
- Molecular formula:
- HMnO4.K
- IUPAC Name:
- potassium manganesoylolate
- Details on test material:
- - Name of test material (as cited in study report): Potassium permanganate
- Molecular formula (if other than submission substance):KMnO4
- Molecular weight (if other than submission substance): 158.03
- Substance type: technical product
- Physical state: solid
- Analytical purity: 99.42
- Impurities (identity and concentrations): Manganese dioxide cca 0.1 %
- Lot/batch No.: 69
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino guinea pigs, BFA
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Breeding farm Bio Test Konárovice, 281 25 Czech Republic
- Age at receiving: 6-7 weeeks
- Weight at study initiation: Exposed group 406,42(+/-)53,04
Control group: 379,87(+/-)50,95
- Housing: Monitored conditions, microbiologically defined background, according to SOP No. 40
- Diet: Pelleted standard diet for experimental animals. ad libitum, MAK 1, made by Bergman, Kocanda Mill
- Water: Drinking tap water, ad libitum, with ascorbic acid, quality corresponding to Regulation No. 252/2004 Czech Coll. of Law.
- Acclimation period: 6 days
- Bedding: Sterilized shavings of soft wood
- Random selection: According to SOP No.42
- Identification of animals: Individual labelling of cages and labelling of the animals
- Stock and health condition: No signs of disease were observed at clinical check-in
- Prophylactic arrangement: Cleaning and disinfection of animal room was performed regularly as it is described in appropriate SOP No.10
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3 °C, permanently monitored
- Humidity (%): 30-70 %, permanently monitored
- Air changes (per hr): approximately 15 air changes
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle: 6 am-6 pm/6 pm-6 am
IN-LIFE DATES: From: 27.3.2006 To: 11.4.2006
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: water for injections and vaselinum album
- Concentration / amount:
- Induction - intradermal injections: 1 % test substance in water for injections
Induction - topical application: 10 % test substance in vaseline
Challenge- topical application: 0.1 % test substance in vaseline.
Total amount of the test substance used for main test was 2.135g:
Induction - intradermal injections – 0.12g
Induction - topical application - 2g
Challenge – 0.015g.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: water for injections and vaselinum album
- Concentration / amount:
- Induction - intradermal injections: 1 % test substance in water for injections
Induction - topical application: 10 % test substance in vaseline
Challenge- topical application: 0.1 % test substance in vaseline.
Total amount of the test substance used for main test was 2.135g:
Induction - intradermal injections – 0.12g
Induction - topical application - 2g
Challenge – 0.015g.
- No. of animals per dose:
- 35 animals
5 for pilot experiment
30 for main study
20 animals in treatment group (6 males and 14 females)-teratment group
10 animals in control group (6 males and 4 females)-control group - Details on study design:
- - Clinical signs: daily, clinical symptoms of intoxication and health condition of animals were observed.
- Mortality/viability: daily
- Body weight: 0 and 24 day, the body weight of animals was recorded one day before the first application (day 0) and after observation of skin
reaction (day 24). The average of group was counted from individual body weight values of animals.
- The skin reaction: 24, 48 and 72 hours after intradermal injection
48, 72 and 96 hours after induction – topical application
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: --
- Test groups: TS in FCA, TS in water(for injection), TS in vaseline (for topical)
- Control group: FCA, water
- Site: shoulder region
- Frequency of applications: 1 st day -intradermal injections and 7th day-topical application
- Duration: 0-9 d
- Concentrations: 1%, 10%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 20
- Exposure period: 24 h
- Test groups: TS in vaseline
- Control group: TS in vaseline
- Site: L flank
- Concentrations: 0,1%
- Evaluation (hr after challenge): 48, 72 h - Positive control substance(s):
- yes
- Remarks:
- Benzocaine (ethyl p-aminobenzoate)
Results and discussion
- Positive control results:
- Reliability of the experimental technique is checked periodically in about six-month interval by the experiment with known sensitiser benzocaine. For intradermal application the 5% concentration in olive oil was used and the challenge exposure was performed by the same concentration in vaselina alba. The result of last experiment (March 2006): positive skin reaction – 4 animals (total number of animals = 10) i.e. 40%. According to the guideline the minimal number of animals with positive skin reaction is expected to be 30%. The result is satisfactory.
The results of reference study test are described in VUOS-CETA internal report No. 0643.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no pathological reaction of skin
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no pathological reaction of skin.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no pathological reaction of skin
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.1 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no pathological reaction of skin.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no pathological reaction of skin
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no pathological reaction of skin.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no pathological reaction of skin
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no pathological reaction of skin.
- Reading:
- other: periodical check of the system
- Group:
- positive control
- Dose level:
- 5% in olive oil
- No. with + reactions:
- 4
- Total no. in group:
- 10
Any other information on results incl. tables
Traditional sensitisation test
Body weight
The body weight of animals was recorded one day before the first application (day 0) and after observation of skin reaction (day 24). The average of group was counted from individual body weight values of animals.
Table 1.: Body weight in grams– mean values +SD
|
Number of animals |
Start of study |
End of study |
Increment |
Exposed group |
20 |
406.42±53.04 |
539.14±68.62 |
+132.72 |
Control group |
10 |
379.87±50.95 |
507.33±87.46 |
+127.46 |
Evaluation of skin reaction after induction
Intradermal injections
The skin reaction evaluation of the test area of all animals from the exposed group showed moderate erythema around the sites of intradermal injections puncture. These changes faded away after 48 hours.
The skin reaction evaluation of the test area of all animals from control group showed discrete erythema around first sites of intradermal injections puncture. These changes faded away after 24 hours.
Topical application The evaluation of skin reactions of exposed group showed in all animals a moderate confluent erythema without oedema in the test area with fade-out time 72 hours.The evaluation of skin reactions in control group with vaseline did not show any changes in skin of all animals.
Evaluation of skin reactions after challenge
Exposed group at 48 hours after the challenge
The evaluation of skin reactions in the exposed group carried out at 48 hoursafter the start of the challenge phase of study did not show any changes on skin of exposed left flank of animals. The other flank of the animals applied with the vaseline only, did not show any skin reactions in all the 20 animals.
Exposed group at 72 hours after the challenge
The evaluation of skin reactions in the exposed group carried out at72 hours after the start of challenge phase of study did not show any changes in skin of the exposed flank of all animals. The other flank did not show any changes in skin of all the 20 animals.
Control group at 48 and 72 hours after the challenge
The evaluation of skin reactions in the control groupcarried out at 48 and 72 hours after the start of the challenge phase of study did not show any changes in skin of animals in both flanks.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- The exposed animals showed no pathological skin reactions and no other negative clinical symptoms throughout the experiment.
The body weight of animals increased throughout the study and it was not affected by the treatment. In the course of experiment the animals did not show any clinical symptoms of intoxication.
The test substance, Potassium permanganate, was not shown to be a contact allergen in guinea pigs. - Executive summary:
The test substance,Potassium permanganate,was tested for the assessment of skin allergic effects using albino guinea pigs (strain BFA).
The test was performed according to the OECD Test Guideline No. 406, Skin sensitisation, which is analogous to the EU Method B.6, Skin sensitisation.
The Magnusson and Kligman maximization procedure was followed. The test was performed on albino guinea pigs (12 males and 23 females).
The experiment proceeded in three phases: two induction phases - topical application and the challenge phase. Potential skin reactions were evaluated at the end of experiment.
The exposed animals showed no allergic skin reactions and no other negative clinical symptoms throughout the experiment.
The test substance, Potassium permanganate, was not shown to be a contact allergen in guinea pigs.
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