Registration Dossier
Registration Dossier
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EC number: 500-041-9 | CAS number: 25723-16-4 1 - 6.5 moles propoxylated
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, GLP Monitoring Authority, UK
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Propylidynetrimethanol, propoxylated
- EC Number:
- 500-041-9
- EC Name:
- Propylidynetrimethanol, propoxylated
- Cas Number:
- 25723-16-4
- Molecular formula:
- C3H5(CH2OR)3 R= (C2H3(CH3)O)nH sum of n: >1 - <6.5 mol PO
- IUPAC Name:
- Propylidynetrimethanol, propoxylated
- Details on test material:
- Propylidenetrimethanol, propoxylated mw 310; clear, colourless, viscous liquid; purity not reported
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca (BKI)
- Sex:
- 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: 15 - 23 g
- Housing: Individually housed in suspended solid-floo polypropylene cages with woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0.5%, 5% or 50% w/v in acetone/olive oil (4:1)
- No. of animals per dose:
- 5
- Statistics:
- Linear regression analysis followed by one way analysis of variance (ANOVA) incorporating Levene’s test for homogeneity of variance. Where variances were shown to be homogenous pairwise comparisons were conducted using Dunnett’s test. Where Levene’s test showed unequal variances the data were analysed using non-parametric methods: Kruskal-Wallis ANOVA and Mann-Whitney ’U’ test.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.03
- Test group / Remarks:
- 0.5%
- Key result
- Parameter:
- SI
- Value:
- 1.17
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- 1.37
- Test group / Remarks:
- 50%
Any other information on results incl. tables
Additional data supporting the information is attached below under 'Attached background material'.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- propylidentrimethanol, propoxylated showed no skin sensitising potential in the Local Lymph Node Assay (LLNA) in female CBA/Ca (BKI) mice after dermal application of up to and including a 50% concentration.
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