Registration Dossier
Registration Dossier
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EC number: 221-242-5 | CAS number: 3039-83-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- extended exposure duration of 24 hours, no 72 hours reading after patch removal.
- GLP compliance:
- no
- Remarks:
- (Study performed prior to implementation of GLP)
Test material
- Reference substance name:
- Sodium ethylenesulphonate
- EC Number:
- 221-242-5
- EC Name:
- Sodium ethylenesulphonate
- Cas Number:
- 3039-83-6
- Molecular formula:
- C2H4O3S.Na
- IUPAC Name:
- sodium ethylenesulphonate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material: Sodium ethylenesulphonate (Sodium vinylsulphonate)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 - 2.0 kg
- Housing: Animals were housed individually
- ERKA 8300 feed (Robert Koch OHG, Hamm, Germany)
- Diet: ad libitum
- Water: tap water, ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved on two sides and one side was abraded
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 mL of the unchanged test item
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 48 hours (reading at 0, 24 and 48 hours after patch removal)
- Number of animals:
- 6 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: Two sides, each 2.5 x 2.5 cm
- Type of wrap if used: surgical patch on a piece of plaster
REMOVAL OF TEST SUBSTANCE
- Washing: no data
SCORING SYSTEM
- Draize scoring system (OECD 404)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded and non abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded and non abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded and non abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded and non abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded and non abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded and non abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded and non abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: abraded and non abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded and non abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded and non abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded and non abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded and non abraded skin
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- (slightly irritating)
- Conclusions:
- Under the conditions of the present skin irritation study with the undiluted test item sodium ethylene sulphonate, only slight skin irritation was observed in one of six rabbits both on intact and abraded skin which was fully reversed within 48 hours after patch removal.
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