N-[2-[2-(2-methoxyethoxy)ethoxy]ethyl]-2-methyl-propan-2-amine

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

12,12-dimethyl-2,5,8-trioxa-11-azatridecane

EC Number:

814-433-5

Cas Number:

926622-96-0

Molecular formula:

C11 H25 N O3

IUPAC Name:

12,12-dimethyl-2,5,8-trioxa-11-azatridecane

Test material form:

liquid

Details on test material:

- State of aggregation: liquid
- Purity: 99.8 corrected area-% by GC/FID For details see analytical report 17L00283.

- Storage stability: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage conditions: Room temperature
- Physical state / color: Liquid / colorless, clear
- Density [g/mL]: 0.921 (determined by Bioassay Laboratories)

Specific details on test material used for the study:

pH value: >11.5 (according to available product information of the sponsor)
Physical state / color: Liquid / colorless, clear
Storage conditions: Room temperature

In vitro test system

Test system:

artificial membrane barrier model

Source species:

other: Corrositex® kit

Details on animal used as source of test system:

Corrositex: InVitro International, Irvine CA, USA

Vehicle:

unchanged (no vehicle)

Details on test system:

The objective was to assess the skin corrosion and irritation potential of 2-Propanamine, N-[2-[2-(2-methoxyethoxy)ethoxy]ethyl]-2-methyl-. By using the methods currently available a single in vitro assay is not sufficient to cover the full range of skin irritating/corrosion potential including transport classification.

The study was conducted in two steps first performing the Skin Corrosion Test (SCT). As a corrosion potential of the test substance could not be excluded, the In vitro Membrane Barrier Test (Corrositex®) was conducted subsequently

Test animals

Species:

other:

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Concurrent treatment : Negative control (NC): 10% citric acid Positive control (PC): Sodium hydroxide (solid)

Amount / concentration applied:

500 µL of the undiluted test substance were added onto the membrane disc

Duration of treatment / exposure:

one time

Observation period:

The vial was observed for three minutes for any change in the CDS.
If no color change was observed within three minutes the membraneswere observed continuously for the first ten minutes. Thereafter, the vials were observed for approximately ten minutes around the time points relevant for evaluation or until breakthrough of the test substance

Details on study design:

The experimental design of this study consisted of
- a qualification screen with the CDS (to determine if a color change can be detected)
- a categorization screen (to categorize weak acids/bases and strong acids/bases
- a definitive Corrositex® assay

Corrositex® assay

Following the acceptance of the positive control, the Corrositex® assay was performed for the test substance. Four vials containing the CDS were used for the test substance.

In addition, one vial was used for the PC, the NC and the color control (blank) each.
A membrane disc coated with the biobarrier matrix was placed into one vial containing the CDS and approximately 500 µL test substance were added onto the membrane disc. The vial was observed for three minutes for any change in the CDS.

If no color change was observed within three minutes the membranes remaining were treated with the test substance. The vials were observed continuously for the first ten minutes. Thereafter, the vials were observed for approximately ten minutes around the time points relevant for evaluation or until breakthrough of the test substance. The elapsed time between test substance application and the first change in the indicator solution (i.e. barrier penetration) was recorded.

The positive control vial was prepared as described above and contained one pellet of sodium hydroxide on top of the membrane disc. This vial was continuously monitored until breakthrough.

The negative control vial was prepared as described above and contained 500 µL 10% citric acid. This vial was observed for 60 minutes and was evaluated as “non-corrosive” if no reaction had been observed.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

penetration time (in minutes)

Value:

63.52

Vehicle controls validity:

not examined

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

Pretest
Qualification screen: the test substance can react with the CDS and produce a visible color change.

Categorization screen: the test substance was assigned to timescale category 1 (having a high acid/alkaline reserve)

4.1.2.2. Maintest
The times recorded:
Vial 1: 68:18 (min)
Vial 2: 62:52 (min)
Vial 3: 63:58 (min)
Vial 4: 60:20 (min)

Mean: 63:52 (min)

Applicant's summary and conclusion

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Conclusions:

The mean breakthrough time determined in the in vitro Membrane Barrier Test (Corrositex®) was 63 minutes and 52 seconds. The breakthrough time indicates that the test substance has a weak corrosive potential and should be assigned to UN GHS skin corrosivity subcategories 1C.

Executive summary:

Based on the results observed and by applying the evaluation criteria it was concluded that 2-Propanamine, N-[2-[2-(2-methoxyethoxy)ethoxy]ethyl]-2-methyl has a weak corrosive potential and should be assigned to UN GHS skin corrosivity subcategory 1C.