Registration Dossier
Registration Dossier
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EC number: 444-240-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 444-240-8
- EC Name:
- -
- Cas Number:
- 302933-83-1
- Molecular formula:
- C55-n H95.5-2n N7 013 Na1.5 (n-0-6) molecular weight: 1097-l4n (n=0-6)
- IUPAC Name:
- Sodium surfactin
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Water for injection, Sufactin sodium
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Japanese Pharmacopoeia water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- A paste was made from a 2:1 mixture of Sodium surfactine and water for injection.
0.75 g of paste (0.5 g Sodium surfactin and 0.75 mL water) - Duration of treatment / exposure:
- 4hr
- Observation period:
- 1, 24, 48 and 72 hrs
- Number of animals:
- 3
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:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 4 hrs semi-occlusive path of 0.75 g of the paste of Sodium surfactin (Sodium surfactin: 0.5 g) on the dorsal region of three rabbits produced no dermal changes in any of the animals. It is concluded from the results that Sodium surfactin has no irritative potential for rabbit skin.
- Executive summary:
4 hrs semi-occlusive path of 0.75 g of the paste of Sodium surfactin (Sodium surfactin: 0.5 g) on the dorsal region of three rabbits produced no dermal changes in any of the animals. It is concluded from the results that Sodium surfactin has no irritative potential for rabbit skin.
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