Poly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy-]

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

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)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

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)xH sum of x: >1 - <6.5 mol PO

IUPAC Name:

Propylidynetrimethanol, propoxylated

Specific details on test material used for the study:

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 - 23g
- Housing: Individually housed in suspended solid-floo polypropylene cages with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and dark

Study design: in vivo (non-LLNA)

No. of animals per dose:

5 mice / group

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 per dose

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)

Results

Results 1

Key result

Parameter:

SI

Value:

< 3

Test group / Remarks:

50%

Results 2

Key result

Parameter:

SI

Value:

< 3

Test group / Remarks:

5%

Results 3

Key result

Parameter:

SI

Value:

< 3

Test group / Remarks:

0.5%

Results 4

Key result

Parameter:

EC3

Remarks on result:

not determinable

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No evidence of skin sensitisation potential was seen under the conditions of this study.

Executive summary:

The skin sensitisation potential of propoxylated propylidenetrimethanol was assessed in mice using the local lymph node assay (LLNA) according to OECD Test Guideline 429. Groups of five female CBA/Ca mice received 0.5%, 5%, or 50% (v/v) test substance diluted using 4:1 acetone: olive oil (AOO). Lymph node stimulation indices of less than three (3) were measured for the 5% test group relative to AOO vehicle mice. The study does not therefore provide any evidence of skin sensitisation potential.