[No public or meaningful name is available]

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 February 2018 to 07 September 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), Testing Guidelines for Toxicology Studies, 12 NouSan No. 8147, 24 November 2000

Deviations:

no

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C18-unsatd., dimers

Cas Number:

61788-89-4

Molecular formula:

C36H64O4 (representative)

IUPAC Name:

Fatty acids, C18-unsatd., dimers

Constituent 2

Reference substance name:

Fatty acids, tall-oil

Cas Number:

61790-12-3

Molecular formula:

C18H32O2 (representative)

IUPAC Name:

Fatty acids, tall-oil

Constituent 3

Reference substance name:

1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-nortall-oil alkyl derivs.

Cas Number:

61791-39-7

Molecular formula:

C22H40N2O (representative)

IUPAC Name:

1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-nortall-oil alkyl derivs.

Test material form:

liquid

Specific details on test material used for the study:

Purity: >95% (nominal); a substance of Unknown or Variable composition, Complex reaction products or Biological materials (UVCB)
Physical state/Appearance: Amber Liquid

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA/Ca (CBA/CaOlaHsd)

Sex:

female

Details on test animals and environmental conditions:

The animals were housed in suspended solid floor polypropylene cages with stainless steel mesh lids and furnished with softwood flakes bedding (Datesand Ltd., Cheshire, UK).

The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70%, respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

Study design: in vivo (LLNA)

Vehicle:

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

Concentration:

Test material at concentrations of 100, 50 or 25 (%w/w) in acetone/olive oil 4:1

No. of animals per dose:

5

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Statistics:

Data was processed to give group mean values for disintegrations per minute and standard deviations where appropriate.

Results and discussion

Positive control results:

α-Hexylcinnamaldehyde, tech., 85% was considered to be a sensitizer under the conditions of the test.

In vivo (LLNA)

Results

Results 1

Key result

Parameter:

SI

Value:

9.54

Test group / Remarks:

25% Concentration (% w/w) in acetone/olive oil 4:1

Results 2

Key result

Parameter:

SI

Value:

11.84

Test group / Remarks:

50% Concentration (% w/w) in acetone/olive oil 4:1

Results 3

Key result

Parameter:

SI

Value:

11.37

Test group / Remarks:

100% Concentration (% w/w)

Any other information on results incl. tables

Table 1: Stimulation Index of the Test Item

Concentration (%v/v) in acetone/olive oil 4:1	Stimulation Index	Result
25	9.54	Positive
50	11.84	Positive
100	11.37	Positive

Applicant's summary and conclusion

Interpretation of results:

Category 1B (indication of skin sensitising potential) based on GHS criteria

Conclusions:

The test material was considered to be a moderate skin sensitizer with an EC3 of 3.48% under the conditions of the test.

Executive summary:

A study was performed to assess the skin sensitization potential of the test item, Fatty acids, C18-unsatd., dimers, compds, with 4,5-dihydro-2-nortall-oil alkyl-1H-imidazole-1-ethanol and tall oil fatty acids, in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear.

Following a preliminary screening test in a female mouse treated with the undiluted test item in which no clinical signs of toxicity were noted,the undiluted test material (100%)was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of five female animals, were treated with 50 µL (25 µL per ear) of the undiluted test item or the test item as asolutioninacetone/olive oil 4:1at concentrations of 50% or25% v/v. A further group offive female animals was treated.

The concentration of test material expected to cause a 3 fold increase in³HTdR incorporation (EC₃value) was calculated to be 3.48% (extrapolated).

The test material, Fatty acids, C18-unsatd., dimers, compds, with 4,5-dihydro-2-nortall-oil alkyl-1H-imidazole-1-ethanol and tall oil fatty acids, was considered to be a moderate skinsensitizerwith an EC₃of 3.48% under the conditions of the test.

The test material is classified as a contact sensitizer (Category 1B) according toaccording to Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures and the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

withacetone/olive oil 4:1alone in the same manner.