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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was conducted between 16 August 2015 and 28 August 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 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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:
05 December 2015

Storage Conditions:
Room temperature in the dark

Test animals

Species:

human

Strain:

not specified

Test system

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

50 µL

Duration of treatment / exposure:

60 minute exposure period

Observation period:

3 minutes and 60 minutes

Number of animals:

n/a

Results and discussion

Any other information on results incl. tables

Direct MTT Reduction

The MTT solution containing the test item did not turn blue. This was taken to indicate the test item did not reduce MTT.

Assessment of Color Interference with the MTT endpoint

The solution containing the test item did not become colored. This was taken to indicate the test item did not have the potential to cause color interference.

Test Item, Positive Control Item and Negative Control Item

Mean OD₅₆₂ values and viabilities for the negative control, positive control and test item are given in the table.

The relative mean viabilities for each treatment group were as follows: 

Exposure Period	Treatment (%)
	Negative Control	Positive Control	Test Item
60 minute	100*	3.6	105.9
3 minute	100*	3.9	108.3

 *The mean viability of the negative control tissues is set at 100%

 

Quality Criteria

The mean OD₅₆₂for the negative control treated tissues was 1.910 for the 3 Minute exposure period and 1.942 for the 60 Minute exposure period. The negative control acceptance criteria were therefore satisfied.

 

The relative mean tissue viability for the positive control treated tissues was 3.6% relative to the negative control following the 60 Minute exposure period. The positive control acceptance criterion was therefore satisfied.

 

In the range 20-100% viability the Coefficient of Variation between the two tissue replicates of each treatment group did not exceed 30%. The acceptance criterion was therefore satisfied.

 

Applicant's summary and conclusion

Interpretation of results:

other: non-corrosive

Remarks:

Criteria used for interpretation of results: not specified

Conclusions:

The test item was considered to be non-corrosive to the skin.