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EC number: 274-778-7 | CAS number: 70693-62-8
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-01-04 - 2001-09-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Pentapotassium bis(peroxymonosulphate) bis(sulphate)
- EC Number:
- 274-778-7
- EC Name:
- Pentapotassium bis(peroxymonosulphate) bis(sulphate)
- Cas Number:
- 70693-62-8
- Molecular formula:
- H3K5O18S4
- IUPAC Name:
- pentapotassium bis((hydroperoxysulfonyl)oxidanide) hydrogen sulfate sulfate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan U. K. Ltd, Bicester, Oxon, UK
- Age at study initiation: 8 11 weeks
- Weight at study initiation: 234 g (males); 216 g (females)
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: distilled water
- Details on dermal exposure:
- TEST SITE
Area of exposure: approx. 10 % of the total body surface
REMOVAL OF TEST SUBSTANCE
Removal of dressing 24 hours after topical application of test substance. Skin was washed with warm water. The treated area was blotted dry with absorbent paper.
TEST MATERIAL
- Amount(s) applied: 1.20 mL test substance dilution/kg bw (corresponding to 2000 mg/kg bw)
- Concentration (in vehicle): 166.7 % w/v (corresponding to 1.667 g/mL) - Duration of exposure:
- 24 hours
- Doses:
- 1.20 mL test substance dilution/kg bw (corresponding to 2000 mg/kg bw)
- No. of animals per sex per dose:
- 5 per sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- Toxicity was estimated without use of a statistic model
Results and discussion
- Preliminary study:
- not indicated
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- male/female
- Dose descriptor:
- other: LOAEL
- Effect level:
- 2 000 mg/kg bw
- Mortality:
- No lethal effect at maximal dose.
LD50: > 2000 mg/kg bw - Clinical signs:
- other: No deaths and no systemic response to treatment (please refer to Table 1, which is presented under "Remarks on results including tables and figures"). Severe dermal irritation was seen in three animals following removal of the dressings persisting until s
- Gross pathology:
- Macroscopic examination revealed a necrotic area on the dose site of three animals and scabbing on the dose site of two animals. No abnormalities were recorded for the remaining animals.
- Other findings:
- - No deaths occurred during the entire study period
- Loss of body weight was recorded for one female and low body weight gains were recorded for two females on day 8
Any other information on results incl. tables
Table 1: Summary of Acute Dermal Toxicity
ose [mg/kg bw] | Sex | Number of dead / | Time of death (range) | Observations |
2000 | male | 0/5 | n.a. | - No clinical signs of systemic toxicity, local irritations at the application site, no effect on body weights and necrotic area or scabbing on the dose site in some animals
|
2000 | female | 0/5 | n.a. | - No clinical signs of systemic toxicity, local irritations at the application site, loss of body weight in one and low body weight gains in two animals and necrotic area or scabbing on the dose site in some animals
|
LD50 value | > 2000 mg/kg bw |
Table 2: Dermal reactions
Dose | Sex | Animal | Erythema | Day | ||||||||||||||
2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | |||||
2000 |
male | 1 | E | ef | bf | bf | bf | bf | bf | bf | bf | bf | bf | bf | bf | bf | bf | |
2 | E | 2ac | 0a | 0a | 0a | 0a | 0a | 0c | 0c | 0c | 0c | 0c | 0c | 0c | 0c | |||
3 | E | 1c | 1c | 1c | 0c | 0c | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
4 | E | 1d | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
5 | E | ef | bf | bf | bf | bf | bf | bf | bf | bf | bf | bf | bf | bf | bf | |||
|
|
|
| |||||||||||||||
female | 6 | E | 1c | 1a | 1a | 0a | 0a | 0a | 0c | 0c | 0c | 0c | 0c | 0c | 0 | 0 | ||
7 | E | 2d | b | b | bf | bf | bf | bf | bf | bf | bf | bf | bf | bf | bg | |||
8 | E | 2a | 1a | 1a | 0a | 0a | 0a | 0a | 0a | 0a | 0a | 0a | 0a | 0a | 0c | |||
9 | E | 0d | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
10 | E | 2d | 1a | 1a | 0a | 0a | 0a | 0d | 0d | 0d | 0d | 0d | 0d | 0d | 0 |
E = Erythema; O = Oedema
a Localised necrosis (assessment of erythema not impaired)
b Necrosis over majority of treatment site (assessment of erythema precluded)
c Localised spots and/or scabbing
d Spots and/or scabbing over the majority of the treatment site
e Blanching over majority of treatment site
f Cracking of the skin at edge of blanched area
g Wet ulceration on dose site
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability). LD50: > 2000 mg/kg bw. No classification and labelling with respect to acute dermal toxicity is required according to Regulation 1272/2008/EC (CLP).
- Executive summary:
Materials and methods
A single dose of 2000 mg of KMPS triple salt/kg bw was topically applied under occlusive conditions onto the clipped dorsal skin of 5 male and 5 female Sprague Dawley (CD) rats for a period of 24 hours. Animals were regularly observed for clinical signs of toxicity, mortality/viability and local reactions. Body weights were recorded on day 1, 8 and 15, respectively. Following a 24 hour exposure period, the test material was removed and animals observed for another 14 days. Thereafter, animals were necropsied and examined macroscopically.
Results and discussion
No deaths and no clinical signs of systemic toxicity were reported following administration of a single dermal dose of 2000 mg KMPS triple salt/kg bw to 5 male and 5 female Sprague Dawley (CD) rats. Severe dermal irritation was seen in three animals following removal of the dressings persisting until study termination. Slight to well‑defined dermal irritation was observed in six animals following removal dressings. These reactions had resolved completely by Day 3 in one animal, Day 5 in one animal and Day 8 in four animals. In addition, localised necrosis, localised spots and/or scabbing, spots and/or scabbing over the majority of the treatment site, blanching over the majority of the treatment site, cracking of the skin at the edge of the blanched area and wet ulceration on the dose site were noted in a number of animals during the study. Loss of body weight was recorded for one female and low body weight gains were recorded for two females on day 8. Macroscopic examination revealed a necrotic area on the dose site of three animals and scabbing on the dose site of two animals. No abnormalities were recorded for the remaining animals.
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