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

Endpoint summary

Description of key information

non-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

Study period:

2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Guideline study under GLP

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)

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.

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)

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.

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

A guideline LLNA test was performed prior to amendments of Regulation EC No. 1907/2006 discouraging in vivo testing for skin sensitisation. In the LLNA, the stimulation index (SI) of the highest dose administered (100%, undiluted) did not meet or exceed the sensitisation threshold (SI) of 3. Therefore, the substance is considered a non-sensitiser.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The test substance was tested in the LLNA using the OECD 429 guideline, prior to the passage of amendments to Regulation EC No. 1907/2006 requiring non-animal testing as an initial approach. The LLNA clearly showed that the substance is evaluated to be a non-sensitiser. The criteria for classification as a dermal sensitiser according to Regulation EC No. 1272/2008 are not met. There is no indication that the substance is a respiratory sensitiser.