Registration Dossier
Registration Dossier
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EC number: 200-289-5 | CAS number: 56-81-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- publication
- Title:
- Activity of human contact allergens in the murine
local lymph node assay - Author:
- Ryan CA et al.
- Year:
- 2 000
- Bibliographic source:
- Contact Dermatitis, 2000, 43, 95–102
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Glycerol
- EC Number:
- 200-289-5
- EC Name:
- Glycerol
- Cas Number:
- 56-81-5
- Molecular formula:
- C3H8O3
- IUPAC Name:
- propane-1,2,3-triol
- Details on test material:
- No additional information available.
Constituent 1
- Specific details on test material used for the study:
- glycerol, 99%
obtained from Sigma-Aldrich Co. Ltd., Dorset, UK
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac, Bicester, Oxfordshire, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known:
- Age at study initiation: 6-12 weeks
Animals were housed under standard conditions and
all procedures were approved by the UK Home Office
and carried out in compliance with the Animals
(Scientific Procedures) Act 1986 under a
Home Office granted Project License.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 25, 50, 100 % v/v
- No. of animals per dose:
- n =4
- Details on study design:
- glycerol was tested in laboratory B
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.5
- Test group / Remarks:
- Glycerol 100% v/v
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- glycerol 50% v/v
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- glycerol 25% v/v
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- vehicle
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Glycerol failed to provoke an SI of 3 or more at any test concentration examined, despite
employing relatively high doses of material (maximum concentration 100%) and is thus considered to be non-sensitising.
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