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Toxicological information

Skin sensitisation

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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:
2003

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

Constituent 1
Chemical structure
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

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.