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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no further information on the test substance (stability, purity)
- GLP compliance:
- no
- Remarks:
- Several quality assurance inspections were carried out
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
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: C. and J. Morton Ltd., Parsonage Farm, England
- Age at study initiation: 3 months
- Weight at study initiation: 3.42 – 3.48 kg
- Sex: Not stateD
Test system
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g
- Preparation of test substance: Not stated - Duration of treatment / exposure:
- Animals were sacrificed on day 2 (eyes were not rinsed throughout the entire study period).
- Observation period (in vivo):
- Both eyes of each animal were examined on the day before administration for signs of pre-existing irritation, reaction or abnormality which eliminate it from the study.
Ocular reactions to treatment were assessed 1 and 24 h after treatment. - Number of animals or in vitro replicates:
- 3 per group
- Details on study design:
- CONTROL
The left eye of each rabbit remained untreated and served as control.
SCORING SYSTEM:
Scoring of ocular lesions (cornea, iris, conjunctivae and chemosis) was according to grading listed in OECD guideline 405.
Additionally assessed were:
- pain response:
No response: 0 (no initial pain)
A few blinks only; normal within one or to minutes: 1 (practically no initial pain)
Rabbit blinks and tries to open eye but reflexes close it: 2 (slight initial pain)
Rabbit holds eye shut and puts pressure on lids, may rub eye with paw: 3 (moderate initial pain)
Rabbit holds eye shut vigorously, may squeal: 4 (severe initial pain)
Rabbit holds eye shut vigorously, may squeal, claw at eye and try to escape: 5 (very severe initial pain)
- ocular lesions:
Cornea
Area of cornea affected by lesion
One-quarter or less, but not zero: 1
Greater than one-quarter, less than one-half: 2
Greater than one-half, less than three-quarters: 3
Greater than three-quarters, up to whole area: 4
Conjunctivae:
Discharge
No discharge: 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals): 1
Discharge with moistening of the lids and hairs just adjacent to the lids: 2
Discharge with moistening of the lids and hairs and affecting a considerable area around the eye: 3
Interpretation of results:
A substance or preparation is considered irritant if, when applied to the eye of the animals, significant ocular lesions are caused which are present 24 h or more after instillation of the test material.
Ocular lesions are considered significant if two or more of the rabbits have mean values at or above the limit values following:
corneal opacity: 2
iris lesions: 1
redness of conjunctivae: 2.5
Chemosis: 2
(The Official Journal of the European Communities, L257/8, Vol. 26, 16/9/83 and L257/19, Vol. 26, 16/9/83)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- animal #1
- Remarks:
- 12TP 677
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- the study was terminated after 1h
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- animal #2
- Remarks:
- 12TP 678
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- the study was terminated after 1h
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- animal #3
- Remarks:
- 12TP 680
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- the study was terminated after 1h
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- the study was terminated after 1h .."
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 12TP 677
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- the study was terminated after 1h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 12TP 678
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- the study was terminated after 1h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- 12TP 680
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- the study was terminated after 1h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- the study was terminated after 1h
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- 12TP 677
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- the study was terminated after 1h
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- 12TP 678
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- the study was terminated after 1h .."
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- 12TP 680
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- the study was terminated after 1h "
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- the study was terminated after 1h "
- Irritation parameter:
- conjunctivae score
- Remarks:
- (chemosis)
- Basis:
- animal #1
- Remarks:
- 12TP 677
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- the study was terminated after 1h
- Irritation parameter:
- conjunctivae score
- Remarks:
- (chemosis)
- Basis:
- animal #2
- Remarks:
- 12TP 678
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- the study was terminated after 1h "
- Irritation parameter:
- conjunctivae score
- Remarks:
- (chemosis)
- Basis:
- animal #3
- Remarks:
- 12TP 680
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- the study was terminated after 1h .."
- Irritation parameter:
- conjunctivae score
- Remarks:
- (chemosis)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- the study was terminated after 1h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- the study was terminated after 1h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- the study was terminated after 1h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- the study was terminated after 1h
- Irritant / corrosive response data:
- not indicated
- Other effects:
- not indicated
Any other information on results incl. tables
Clinical signs:
Not stated
Average score:
Please refer to tables 1 to 4
Cornea: Average score of all animals at 24 h was 3.0
Iris: Average score of all animals at 24 h was 0.0
Conjunctiva:Please refer to tables 2 to tables 4
Redness: Average score of all animals at 24 h was 3.0
Chemosis:Average score of all animals at 24 h was 2.7
Reversibility: No
Observed changes were considered to be due to necrosis, and consequently the study was terminated and the animals were killed on humane reasons 24 h after treatment.
Overall result:
Instillation of RD/1/85 into the conjunctival sac of three rabbits caused severe ocular lesions which were apparent in all animals within 1 h.
Principal changes included nacreous areas of opacity covering the whole of the cornea, a beefy-red appearance to the conjunctivae, marked chemosis and a creamy white ocular discharge. In addition, the lower conjunctival and nictitating membranes of all rabbits and one third of the one rabbit appeared white. It was considered that theses latter changes were due to necrosis, and consequently the study was terminated and the animals killed.
Instillation of the test material caused practically no initial pain responses in all animals.
Table 1: Values for ocular lesions 24 h after single ocular instillation of 0.1 g KMPS triple salt
Animal No. | Corneal opacity | Iridial lesions | Redness of Conjunctiva | Chemosis |
12TP677 | 3.0 | 0.0 | 3.0 | 3.0 |
12TP678 | 3.0 | 0.0 | 3.0 | 3.0 |
12TP680 | 3.0 | 0.0 | 3.0 | 2.0 |
Table 2: Grades for ocular irritation responses following instillation of 0.1 g KMPS triple salt (animal 12TP 677, pain evaluation response: 1)
- | - | Grade of response at time after instillation | |
Region of the eye | Response | 1 h | 24 h |
Cornea | Opacity | 3 | 3 |
" | Area | 4 | 4 |
" | Ulceration | - | - |
" | Stippling | - | - |
Iris | Value | 0 | 0 |
Conjunctiva | Redness | 1B | 3 |
" | Chemosis | 2 | 3 |
" | Discharge | 1 | 3C |
" | Necrosis | - | - |
" | Ulceration | - | - |
B Lower conjunctival membranes and nictitating membrane whitened
C Discharge white and creamy
Table 3: Grades for ocular irritation responses following instillation of 0.1 g KMPS triple salt (animal 12TP 678, pain evaluation response: 1)
- | - | Grade of response at time after instillation | |
Region of the eye | Response | 1 h | 24 h |
Cornea | Opacity | 3 | 3 |
" | Area | 3 | 4 |
" | Ulceration | - | - |
" | Stippling | - | - |
Iris | Value | 0 | 0 |
Conjunctiva | Redness | 1B | 3 |
" | Chemosis | 2 | 3 |
" | Discharge | 1 | 3C |
" | Necrosis | - | - |
" | Ulceration | - | - |
B Lower conjunctival membranes and nictitating membrane whitened
C Discharge white and creamy
Table 4: Grades for ocular irritation responses following instillation of 0.1 g KMPS triple salt (animal 12TP 680, pain evaluation response: 1)
- | - | Grade of response at time after instillation | |
Region of the eye | Response | 1 h | 24 h |
Cornea | Opacity | 4 | 3D |
" | Area | 1 | 4D |
" | Ulceration | - | - |
" | Stippling | - | - |
Iris | Value | 1 | 0 |
Conjunctiva | Redness | 1B | 3 |
" | Chemosis | 2 | 2 |
" | Discharge | 1 | 3C |
" | Necrosis | - | - |
" | Ulceration | - | - |
B Lower conjunctival membranes and nictitating membrane whitened
C Discharge white and creamy
D Area white
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability). Under the conditions of this test, KMPS triple salt was classified as eye damaging cat. 1 (causes severe eye damage) according to Regulation 1272/2008/EC.
- Executive summary:
Materials and methods
This study was performed to assess acute eye irritation effects of KMPS triple salt in rabbits.
A quantity of 0.1 g of the test substance was instilled into the right eye of each of three healthy NZW rabbits. Ocular irritation was evaluated 1, and 24 h after instillation of the test substance.
Results and discussion
Please refer to tables 1 to 4, which are presented under “Remarks on results including tables and figures”.
Instillation of KMPS triple salt into the conjunctival sac of three rabbits caused severe ocular lesions which were apparent in all animals within 1 h and justified the termination of the test on humane ground, 24 h after treatment.
Principal changes included nacreous areas of opacity covering the whole of the cornea, a beefy-red appearance to the conjunctivae, marked chemosis and a creamy white ocular discharge. In addition, the lower conjunctival and nictitating membranes of all rabbits and one third of the one rabbit appeared white. It was considered that these latter changes were due to necrosis, and consequently the study was terminated and the animals killed.
Instillation of the test material caused practically no initial pain responses in all animals.
The values for ocular lesions recorded 24 h after treatment exceeded the limit values for classifying the test material as irritant to the eyes.
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