Registration Dossier

Administrative data

Description of key information

Skin sensitisation in vivo (LLNA, OECD 429): not sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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)
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
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.
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%

Additional data supporting the information is attached below under 'Attached background material'.

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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

In order to investigate the skin sensitisation potential of propylidentrimethanol, propoxylated (CAS No. 25723-16-4, EC No. 500-041-9), a Local Lymph Node Assay (LLNA) was performed according to OECD guideline 429 under GLP conditions (rel 1-key, LLNA, OECD 429, Safepharm, 2003, 1691/029). 20 female CBA/Ca (BKI) mice (5 animals/test item group and 5 control animals) were used to determine if there is any specific (sensitising) stimulating potential of the test substance. The following test substance concentrations were used: 0 (vehicle control), 0.5%, 5% and 50% formulated in acetone/olive oil (4:1). The Stimulation Index (SI) expressed as the pooled radioactive incorporation for each treatment group divided by the incorporation of the pooled vehicle control group was as follows: 1.03, 1.17 and 1.37 for the 0.5, 5 and 50% test substance concentrations, respectively. The experiment resulted in SI values of less than 3, the threshold for identifying a test substance as skin sensitiser. There was no mortality during the experimental phase and no clinical signs of systemic toxicity were observed in any animal, either in the treatment groups or the control group. The body weight development of the treated animals was comparable to that observed for the control group mice. In conclusion, the results show that propylidentrimethanol, propoxylated has no sensitising potential in mice after dermal application of solutions with up to and including a concentration of 50%.

Justification for classification or non-classification

The available data on skin sensitisation with propylidentrimethanol, propoxylated (CAS No. 25723-16-4, EC No. 500-041-9) do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP) and are therefore conclusive but not sufficient for classification.