Glycerides, tallow sesqui-, hydrogenated, propoxylated

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 January 2016 - 08 March 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

1

Reference substance name:

Glycerides, tallow sesqui-, hydrogenated, propoxylated

EC Number:

614-598-1

Cas Number:

68553-12-8

Molecular formula:

n/a

IUPAC Name:

Glycerides, tallow sesqui-, hydrogenated, propoxylated

In vivo test system

Test animals

Species:

mouse

Strain:

CBA/Ca

Remarks:

CBA/CaOlaHsd

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

10%, 25% or 50%.

No. of animals per dose:

Five/dose

Positive control substance(s):

not specified

Statistics:

The data was processed to give group mean values for disintegrations per minute and standard deviations where appropriate. individual and group means disintegrations per minute values were assessed for dose response relationships. Data was first assessed for suitability by analysis of normality and homogeneity of variance. If the asseumptions that the data are both normally distributed and has homogeneity of variances, then parametric one way analysis of variance (ANOVA) and Dunnett's multiple comparison procedure were used to determine statistical significance. If the assumptions were not met, non-parametric Kruskal-Wallis Rank Sum and Mann-Whitney U test procedures were used.

Probability values (p) are presented as follows:
P<0.001 ***
P<0.01 **
P<0.05 *
P>/=0.05 (not significant)

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

1.21

Test group / Remarks:

10%

Results 2

Parameter:

SI

Value:

2.01

Test group / Remarks:

25% in acetone/olive oil 4:1

Results 3

Key result

Parameter:

SI

Value:

2.46

Test group / Remarks:

50% in acetone/olive oil 4:1

Any other information on results incl. tables

Concentration (%w/w) in acetone/olive oil 4:1	Stimulation Index	Result
10	1.21	Negative
25	2.01	Negative
50	2.46	Negative

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance was considered to be a non-sensitiser under the conditions of the test.

Executive summary:

In a local lymph node assay to evaluate the sensitisation potential of the substance female mice (five animals/concentration) were exposed to the substance for 3 consecutive days. The SI of 2.46 (at the highest concentration) indicates that the test material is not a sensitiser.