2-{2-[(2-ethylhexyl)oxy]ethoxy}ethyl prop-2-enoate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was conducted between 15 September 2015 and 15 October 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: 1= Reliable without restriction o GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

2-{2-[(2-ethylhexyl)oxy]ethoxy}ethyl prop-2-enoate

Cas Number:

117646-83-0

Molecular formula:

C15H28O4

IUPAC Name:

2-{2-[(2-ethylhexyl)oxy]ethoxy}ethyl prop-2-enoate

Test material form:

other: liquid

Details on test material:

Identification:
M120

Batch:
NC-5635-01

Purity:
not supplied

Physical state / Appearance:
clear colorless liquid

Expiry Date:
05 December 2015

Storage Conditions:
room temperature in the dark

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

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

Concentration:

25%, 10% or 5% v/v

No. of animals per dose:

4

Positive control substance(s):

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

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: 5% v/v 2.78 10% v/v 7.47 25% v/v 7.39

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: 5% v/v 50530.05 10%v/v 135981.70 25% v/v 134424.40

Any other information on results incl. tables

Preliminary Screening Test

No signs of systemic toxicity were noted. Very slight erythema was noted on both ears of all animals during the test. A greater than 25% increase in mean ear thickness was noted in animals treated with the undiluted test item or the test item at a concentration of 50% v/v in acetone/olive oil 4:1. No irritation indicated by an equal to or greater than 25% increase in mean ear thickness was noted in the animal treated with the test item at a concentration of 25% v/v in acetone/olive oil 4:1.

 

Based on this information the dose levels selected for the main test were 25%, 10% and 5% v/vinacetone/olive oil 4:1.

  

Main Test

Estimation of the Proliferative Response of Lymph Node Cells

The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:

Concentration (%v/v) in acetone/olive oil 4:1	Stimulation Index	Result
5	2.78	Negative
10	7.47	Positive
25	7.39	Positive

Clinical Observations and Mortality Data

There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.

  

Body Weight

Body weight change of the test animals between Day 1 and Day 6 was comparable to that observed in the corresponding control group animals over the same period.

  

Calculation of EC₃Value

aEC₃= c + [[(3-d)/(b-d)] x (a-c)]

a	=	10
b	=	7.47
c	=	5
d	=	2.78
EC3 = 5+ [[(3-2.78)/(7.47-2.78)] x (10-5)] = 5.2

 

The concentration of test item expected to cause a 3 fold increase in³HTdR incorporation (EC₃value) was calculated to be 5.2%.

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item was considered to be a sensitizer under the conditions of the test.