Registration Dossier
Registration Dossier
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EC number: 420-660-7 | CAS number: 74135-10-7 NATRIUM-SUCROSEOCTASULFAT
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.4; OECD 401
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- NatriumSucroseoctasulfat
- IUPAC Name:
- NatriumSucroseoctasulfat
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- moistening with 0,5 ml water
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.67
- Irritation parameter:
- erythema score
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 72 d; Max. value at end of observation period: 1 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 4 days
- Other effects:
- Keine
"ENGLISH"
none
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Executive summary:
The potential toxicity of "Natrium-Sucroseoctasulfat" was assessed in an acute dermal irritation/corrosion test on 3 albino rabbits. The skin was exposed to the test article for 4h. Animals were examined for signs of erythema and oedema at 60 min, 24, 48, 72 h and at day 4 after patch removal.
Slight to moderate redness was observed in two animals. The observed finding was reversible within 4 days p.a.
The mean grades of skin reactions at 24, 48, 72 h after patch removal where lower than the calue classified as irritant ny the EEC directive 93/21/EEc of April 27, 1993.
When applied to the skin, the test article "Natrium-Sucroseoctasulfat" may therefore be classified as non-irritant.
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