Registration Dossier
Registration Dossier
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EC number: 500-044-5 | CAS number: 25791-96-2 1 - 6.5 moles propoxylated
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1a guideline study. Study was conducted in accordance to GLP and OECD guideline 406.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
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:
- A Buehler study was conducted according to OECD 406. Male and Female Dunkin Hartley guinea pigs (10 males and 10 females) received 0.5 undiluted test substance. Propoxylated glycerol mw 300 is not a skin sensitizer when tested using the Buehler technique.
Test material
- Reference substance name:
- Glycerol, propoxylated
- EC Number:
- 500-044-5
- EC Name:
- Glycerol, propoxylated
- Cas Number:
- 25791-96-2
- Molecular formula:
- (C3 H6 O)n (C3 H6 O)n (C3 H6 O)n C3 H8 O3 n=>1-<6.5 mol PO
- IUPAC Name:
- alpha, alpha’, alpha’’-1,2,3-propanetriyltris[w-hydroxypoly(oxy-methyl-1,2-ethanediyl)]
- Details on test material:
- Test substance: Propoxylated glycerol mw 300 (NLP) clear viscous liquid.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Ltd, Staffs, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 307-399g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: undiluted
- Concentration / amount:
- 0.5 ml undiluted material
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: undiluted
- Concentration / amount:
- 0.5 ml undiluted material
- No. of animals per dose:
- 10 males and 10 females - Treated group
5 males and 5 females - Control group - Details on study design:
- 1st application: Induction undiluted occlusive epicutaneous
2nd application: Challenge undiluted occlusive epicutaneous
RANGE FINDING TESTS: A 6 hour occlusive application of 0.5 ml undiluted material did not cause any skin reaction at 24 or 48 hours.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hour
- Test groups: 2
- Control group: 1
- Site: Skin
- Frequency of applications: 1, 7 and 14 day
- Duration: 6 hours
- Concentrations: 0.5 ml undiluted material
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 6 hour
- Test groups: 2
- Control group: 1
- Site: Skin
- Frequency of applications: 28 day
- Duration: 6 hours
- Concentrations: 0.5 ml undiluted material - Positive control substance(s):
- yes
- Remarks:
- 2,4-DNCB
Results and discussion
- Positive control results:
- Report has included positive control data for the known contact sensitiser 2,4-DNCB carried out using a M&K maximisation procedure (presumably in error).
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.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Propoxylated glycerol mw 300 is not a skin sensitier when tested using the Buehler technique.
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