Registration Dossier
Registration Dossier
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EC number: 500-118-7 | CAS number: 52625-13-5 1 - 12.5 moles propoxylated
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 30, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
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:
- D-Glucitol, propoxylated
- EC Number:
- 500-118-7
- EC Name:
- D-Glucitol, propoxylated
- Cas Number:
- 52625-13-5
- Molecular formula:
- (C3 H6 O)n (C3 H6 O)n (C3 H6 O)n (C3 H6 O)n (C3 H6 O)n (C3 H6 O)n C6 H14 O6 sum of n: >1 - <12.5 mol PO
- IUPAC Name:
- D-Glucitol, propoxylated
- Details on test material:
- D-glucitol, propoxylated, (Mn = approx. 600 g/mol)
- Lot/batch no.: 900413RGIV
- Analytical purity: > 99.5 %
Constituent 1
Test animals
- Species:
- rabbit
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 ml undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 ,72 hr mean
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 ,72 hr mean
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 ,72 hr mean
- Score:
- 0.7
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 ,72 hr mean
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 ,72 hr mean
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 ,72 hr mean
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: mean
- Score:
- 0.5
- Irritant / corrosive response data:
- One treated skin showed very slight erythema at time points 1h, 24h, 48h, 72h, and no erythema but desquamation at 7 days. One skin did not react to the treatment. The third showed very slight erythema at time-points 24h and 48h, only.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- According to the Draize scheme, the primary irritation index of 0.5 leads to the result "slightly irritating". The test item does however not meet the EEC classification criteria.
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