Registration Dossier
Registration Dossier
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EC number: 231-665-7 | CAS number: 7681-38-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987-08-04 to 1987-08-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study reliable without restrictions GLP certificate is missing. The study was conducted before compulsory of GLP. No histopathological record
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 12 May 1981
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium hydrogensulphate
- EC Number:
- 231-665-7
- EC Name:
- Sodium hydrogensulphate
- Cas Number:
- 7681-38-1
- Molecular formula:
- H2O4S.Na
- IUPAC Name:
- sodium hydrogen sulfate
- Reference substance name:
- sodim hydrogensulphate
- IUPAC Name:
- sodim hydrogensulphate
- Details on test material:
- - Name of test material (as cited in study report): Sodium hydrogen sulphate
- Physical state: pale yellow, pearly product
- Analytical purity: 95 % NaHSO4
- Composition of test material, percentage of components: 95 % NaHSO4; 5 % Na2SO4
- Batch No.: AZBG 015
- Storage condition of test material: in the dark at 22 °C in the extractor hood
No further information on test material was stated.
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breeding
- Age at study initiation: ca. 3 - 5 months
- Weight at study initiation: 2.0 - 3.4 kg
- Housing: individually in accclimatised rooms
- Diet (ad libitum): Altromin 2123 Haltungsdiät - rabbit, Altromin -GmbH, Lage/Lippe; in addition hay (ca. 15 g daily)
- Water (ad libitum): deionised, chlorinated water
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Relative humidity: 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 /12
No further information on test animals was stated.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 500 mg sodium hydrogen sulphate with 0.3 ml 0.9 % NaCl solution
VEHICLE
- Amount(s) applied: 0.3 ml 0.9 % NaCl solution
No further information was stated. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Observation at 30-60 minutes as well as at 24, 48, 72 hours after application.
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 24 hours before testing the fur of the dorsal area of the trunk was removed (area of 25 cm^2). The test substance with 0.3 ml 0.9 % NaCl-soultion was applied onto a 2.5 X 2.5 cm band-aid. The band-aid was fixed onto the shaved skin of the rabbits and a semiocclusive coverage was applied.
REMOVAL OF TEST SUBSTANCE
- Washing: After exposure the remaining test substance was carefully removed with tepid water.
SCORING SYSTEM:
Draize scoring system
No further information was stated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24h, 48h, and 72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as skin irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.
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