Coconut oil, reaction products with boric acid (H3BO3), diethanolamine and glycerol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 30, 2016 to August 26, 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)

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Coconut oil, reaction products with boric acid (H3BO3), diethanolamine and glycerol

EC Number:

806-731-9

Cas Number:

1428353-74-5

Molecular formula:

Substance is a UVCB.

IUPAC Name:

Coconut oil, reaction products with boric acid (H3BO3), diethanolamine and glycerol

Test material form:

other: liquid

Details on test material:

Identification: TS13001Physical state/Appearance:amber colored liquidExpiry Date: 30 January 2015Storage Conditions:room temperature in the darkIntended use/Application: Lubricating oil additive

In vivo test system

Test animals

Species:

mouse

Strain:

CBA:J

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

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

Concentration:

10, 25, and 50% (w/v)

No. of animals per dose:

5

Results and discussion

Positive control results:

Positive control responded as expected

In vivo (LLNA)

Results

Key result

Parameter:

EC3

Value:

3.9

Any other information on results incl. tables

All animals survived the in-life phase of the study. There were no difficulties in administration of

the test article or with its adherence to the dosed ears. Body weight changes were normal in the QIT. In the

main test, body weight losses were noted but were not significant (<2g). Ear thickness measurements and

individual animal observations indicated that none of the test article treatments resulted in excessive local

dermal irritation.

ID	SI	%B change	%T	B:T change	I-A^kchange	I-A^k:CD69 change
Vehicle	1.0	1.00	70.8	0.99	1.00	1.00
25% HCA (positive control)	5.1	1.52	64.7	1.64	1.51	1.43
0.1% DNCB (positive control)	6.8	1.86	64.9	2.00	1.42	1.20
10% Test Article	4.1	1.11	71.2	1.09	1.27	1.22
25% Test Article	6.7	1.72	65.0	1.84	1.60	1.51
50% Test Article	7.7	1.83	64.9	1.96	1.52	1.31

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Topical application of test article at 10%, 25%, and 50% (w/v) inAOO resulted in SI values greater than 3 (SI > 3). Therefore, this test article is a dermal sensitizer in the LocalLymph Node Assay. Treatment with the test article at 25% and 50% (w/v) resulted in more than a 25% foldincrease compared to the vehicle control for all of the immunophenotyping markers tested. Immunophenotypingresults confirmed that the test article is a dermal sensitizer.

Executive summary:

The substance is classified as a skin sensitizer based on results in a guideline LLNA study. The SI was > 3 at all doses tested (10, 25, 50% (w/v)) and the sensitization response was confirmed with immunophenotyping (positive response at 25 and 50% (w/v)). The EC3 was calculated to be 3.9.

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