Registration Dossier
Registration Dossier
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EC number: 274-778-7 | CAS number: 70693-62-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983-11-25 - 1983-12-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
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:
- rabbit
- Strain:
- other: Albino rabbit (White Russian)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld, Germany
- Age at study initiation: 16 weeks
- Weight at study initiation: 2.0 – 2.1
- Sex: females
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- 0.5 g test substance were moistened with 0.15 mL demineralised water.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Postexposure period : 14 days
Examination time points: 60 min, 24 h, 48 h, and 72 h after removal of the test patches - Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
The dorsal fur was clipped. The test substance (0.5 g) was applied on dorsal skin and covered by a linen patch on an area of about 6.25 cm². The skin was divided into two areas on both sides of the spinal column of each animal. The two areas on the left side consisted of intact skin, the areas on the right side of sacrificed skin. Each side was covered by a patch. Two were for the protection of the treated skin areas and two for the untreated control area. An bandage occluded and secured the patches.
REMOVAL OF TEST SUBSTANCE
Removal of occlusive dressing after 4 hours.
SCORING SYSTEM
Numerical scoring system as given in the OECD/EU testing guidelines.
CONTROLS
The untreated skin served as control.
EXAMINATIONS
- Clinical signs: Not stated
- Dermal examination: Yes
- Other examinations: Systemic-toxic abnormalities were recorded
- No necropsy was performed in the animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: discolouration; eschar formation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: discolouration; eschar formation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: discolouration; eschar formation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: discolouration; eschar formation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritant / corrosive response data:
- ERYTHEMA: Only results of the intact skin were reported:
Grade 1 hour after exposure: 3.00
Grade 24, 48, 72 hours after exposure: 4.0
OEDEMA: Only results of the intact skin were reported:
Grade 1 hour after exposure: 1.33
Grade 24 hours after exposure: 1.00
Grade 48 hour after exposure: 0.67
Grade 72 hours after exposure: 0.00
Mean grade 24 - 72 h after exposure: 4.00 (erythema), 0.56 (oedema)
Please refer to table 1, which is presented under “Remarks on results including tables and figures”. - Other effects:
- There were no systemic intolerance reactions.
Any other information on results incl. tables
Table 1: Single and means of skin reaction
- | Hours after exposure | Skin reaction | Mean | ||
Animal No. | |||||
1 | 2 | 3 | |||
Erythema/Scabbing | 1 | 2 | 3 | 4 | 3.00 |
24 | 4 | 4 | 4 | 4.00 | |
48 | 4 | 4 | 4 | 4.00 | |
72 | 4 | 4 | 4 | 4.00 | |
24 - 72 | - | 4.00 | |||
Oedema | 1 | 2 | 1 | 1 | 1.33 |
24 | 1 | 1 | 1 | 1.00 | |
48 | 1 | 0 | 1 | 0.67 | |
72 | 0 | 0 | 0 | 0.00 | |
24 - 72 | - | - | - | 0.56 | |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability). Based on Regulation 1272/2008/EC (CLP), KMPS triple salt has to be classified as corrosive to skin.
- Executive summary:
Materials and methods
The skin irritating potential of KMPS triple salt was investigated in three healthy female Albino Rabbits (White Russian). A quantity of 0.5 g of moistened test material was applied to the clipped dorsal fur for a period of 4 hours under occlusive conditions. Skin readings were made 1, 24, 48 and 72 hours after removal of the occlusive dressing, and assessed for erythema and oedema. During the entire study period, animals were observed for clinical signs of toxicity and mortality.
Results and discussion
Clinical signs of toxicity/mortality: No systemic toxicity was stated and no mortalities occurred.
Irritation: Severe erythema were stated around the white coloured treated skin (mean score 24 - 72 h after exposure: 4.0). These erythema were irreversible within the post-exposure period of 14 days. Oedema were observed 1 hour after exposure (score 1.0 in case of two animals and 2.0 in case of one animal). Oedema were shown to be completely reversible within two days (possibly a result of the oxidising properties of the test material).
Coloration: the treated skin was white.
Corrosion: irreversible skin destruction of the treated skin were observed.
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