Fatty acids, C16-18 and C18-unsatd., reaction products with glycidyl neodecanoate and 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Guideline study under GLP

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)

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Esterification reaction of fatty acids, C16-18 and C18-unsatd.; 3,4-epoxycyclohexyl methyl-3,4-epoxycyclohexan carboxylate and neodecanoic acid, oxiranylmethyl ester

Molecular formula:

not available for UVCB substances

IUPAC Name:

Esterification reaction of fatty acids, C16-18 and C18-unsatd.; 3,4-epoxycyclohexyl methyl-3,4-epoxycyclohexan carboxylate and neodecanoic acid, oxiranylmethyl ester

Test material form:

liquid

Details on test material:

UVCB Purity 100% Batch Number 210164480 Expiration Date December 12 2017

In vivo test system

Test animals

Species:

mouse

Strain:

CBA/Ca

Sex:

female

Details on test animals and environmental conditions:

The animals were housed individually in plastic cages suspended on stainless steel racks, in a room equipped with central air-conditioning. The room temperature was within the range of 22 ±2°C, relative humidity was within the range of 55 ±10 %(1).The light regimen was set to a 12-hour light / 12-hour dark cycle.The sanitation was performed according to standard operation procedures.
Laboratory food Altromin was given ad libitum.
Water was provided ad libitum.

Study design: in vivo (LLNA)

Vehicle:

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

Concentration:

100, 50 and 25%

No. of animals per dose:

5 females –control (vehicle)
5 females –positive control
15 females –test substance
6 females -pre-screen test plus spare animals

Positive control substance(s):

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

Results and discussion

Positive control results:

25% HCA resulted in a stimulation index of 6.23. This is within the historical control values for this laboratory and the positive control is considered valid.

In vivo (LLNA)

Results

Key result

Parameter:

SI

Value:

>= 1.965 - <= 2.661

Test group / Remarks:

25-100%

Remarks on result:

other: valid LLNA result: negative

Remarks:

Not sensitising

Any other information on results incl. tables

Calculated SI values in treated groups remained under the value of 3, which is the threshold to consider the substance a sensitiser. All treated animal survived, gained weight, and there were no clinical signs noted. Therefore, the substance is considered a non-sensitiser.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was tested in the LLNA using the OECD 429 guideline, and found to be a non-sensitiser under the conditions of this study.