Registration Dossier
Registration Dossier
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EC number: 500-118-7 | CAS number: 52625-13-5 1 - 12.5 moles propoxylated
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 1, 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 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- reliable Buehler test dated 1991 is available and indicates that the test material is not sensitizing
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
In vivo test system
Test animals
- Species:
- guinea pig
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
Challenge
- Route:
- epicutaneous, occlusive
- No. of animals per dose:
- 20 animals (0.5 ml induction, 0.5 ml challenge)
10 animals control. - Details on study design:
- 1st application: Induction undiluted occlusive epicutaneous
2nd application: Challenge undiluted occlusive epicutaneous
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 ml undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 ml undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 ml undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 ml undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Any other information on results incl. tables
No skin reactions were reported for test or control animals at any timepoint, hence the sensitisation rate was 0% (0/20).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test materila is not sensitising accorrding to the Buehler test.
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