Registration Dossier
Registration Dossier
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EC number: 237-403-8 | CAS number: 13774-25-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2004-04-13 to 2004-04-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- see attachment “Read-across concept – Human Health/Environment - Category approach for Inorganic sulfites/thiosulfates/dithionite" in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002-04-24
- Deviations:
- yes
- Remarks:
- , occlusive dressing (not considered to influence the results of the study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Potassium hydrogen sulphite
- EC Number:
- 231-870-1
- EC Name:
- Potassium hydrogen sulphite
- Cas Number:
- 7773-03-7
- Molecular formula:
- H2O3S.K
- IUPAC Name:
- Potassium hydrogen sulfite
- Test material form:
- other: solution
- Details on test material:
- - Name of test material (as cited in study report): potassium bisulfite solution
- Physical state: clear solution
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - albino rabbits
- Source: Allevamento "Conelli" - Arona (NO)
- Weight at study initiation: 2820 - 2950 g
- Housing: individual housing in cages (NORYL; polyphenylenoxid; 48.2 cm x 63 cm x 37 cm)
- Diet: standard pellets (Harlan Italy)
- Water (ad libitum): cleaned water
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 60 minutes as well as 24, 48, and 72 hours after application
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 24 hours before the test item application the backs and the hips of the rabbits were shaved (area: 240 cm²). The test item was applied onto a gauze patch (2.5 cm x 2.5 cm), which was placed onto the shaved skin and secured with a plaster.
REMOVAL OF TEST SUBSTANCE
- Washing: after exposure the bandage and plaster were removed. The test substance was removed from the skin with physiological solution.
SCORING SYSTEM: according to the Draize scale
OBSERVATIONS:
- clinical signs were observed daily
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- None of the rabbits showed any signs of skin irritation or oedema.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Potassium bisulfite solution is not irritating to the skin of the rabbits.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item should not be classified as irritating to the skin.
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