N-methyldiallylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Version / remarks:

29 July, 2016

Deviations:

no

Remarks:

No deviations occurred that impacted the study integrity or interpretation of the results.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-methyldiallylamine

EC Number:

219-354-4

EC Name:

N-methyldiallylamine

Cas Number:

2424-01-3

Molecular formula:

C7H13N

IUPAC Name:

methylbis(prop-2-en-1-yl)amine

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch 20160912
- Expiration date of the lot/batch: 01 August 2018
- Purity test date: 25 July 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stable until 01 August 2018
- Stability under test conditions: Stable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article was applied neat.

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: Normal, human-derived epidermal keratinocytes that have been cultured to form a multilayered, highly differentiated model of the human epidermis.

Cell source:

other: MatTek Keratinocyte strain: 4F1188

Source strain:

other: Human

Details on animal used as source of test system:

SOURCE ANIMAL
- Source: Human: MatTek Keratinocyte strain: 4F1188

Justification for test system used:

Test system recommended by OECD Guideline 431.

Vehicle:

unchanged (no vehicle)

Details on test system:

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 C
- Temperature of post-treatment incubation (if applicable): 37 C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: No data
- Observable damage in the tissue due to washing: No data
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: TECAN Infinite M200 Pro Plate Reader
- Wavelength: 570 nm
- Filter: No data
- Filter bandwidth: No data
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3
PREDICTION MODEL / DECISION CRITERIA
The in vitro skin corrosion test is considered acceptable if it meets the following criteria:
a) The absolute mean OD570 of the two tissues of the negative control should reasonably be
within the laboratory historical control data range.
b) The mean relative tissue viability following 1-hour exposure to the positive control
should be <15 %.
c) In the range 20 - 100% viability, the Coefficient of Variation (CV) between tissue
replicates should be less than or equal to 30%.
d) The %NSC should be less than or equal to 30% relative to the negative control OD.
e) The non-specific MTT reduction should be less than or equal to 30% relative to the negative control OD.
A test item is considered corrosive in the in vitro skin corrosion test if:
a) The relative mean tissue viability obtained after 3-minute treatment compared to the
negative control tissues is decreased below 50%.
b) In addition, a test item considered non-corrosive (viability 50%) after the 3-minute
treatment is considered corrosive if the relative tissue viability after 1-hour treatment with
the test item is decreased below 15%.
A test item is considered non corrosive in the in vitro skin corrosion test if:
a) The relative mean tissue viability obtained after the 3-minute treatment compared to the
negative control tissues is not decreased below 50%.
b) In addition, the relative tissue viability after the 1-hour treatment is not decreased below
15%.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

yes, concurrent MTT non-specific colour control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 uL

VEHICLE: None

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): Milli-Q water: 50 uL

POSITIVE CONTROL
- Amount(s) applied (volume or weight): Potassium hydroxide: 50 uL
- Concentration (if solution): 8N

Duration of treatment / exposure:

3 minutes, 1 hour

Duration of post-treatment incubation (if applicable):

3 hours

Number of replicates:

4

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 minute exposure

Value:

ca. 90

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1 hour exposure

Value:

ca. 6.3

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other:

Remarks:

Tissue viability after 1-hour exposure is less than 15%, indicating that the test article is corrosive.

Other effects / acceptance of results:

- OTHER EFFECTS:
- Visible damage on test system: No data
- Direct-MTT reduction: The test article does not directly reduce MTT
- Colour interference with MTT: None

DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

Based on the results of the study, the test article is corrosive to the skin.

Executive summary:

The skin corrosion potential of MTDID 49220 was evaluated through topical application on a reconstructed human epidermal model for 3 minutes and 1 hour exposures. The study was conducted according to OECD 431 (2017) and was conducted in compliance with OECD GLP. Batch 20160912 of MTDID 49220 was a clear yellow liquid. MTDID 49220 was applied undiluted (50 μl) directly on top of the skin tissue. Negative (Milli-Q water) and positive (8N Potassium hydroxide) controls were tested concurrently. The relative mean tissue viability for test article-treated tissues obtained after 3-minute and 1-hour treatments with MTDID 49220 compared to the negative control tissues was 90% and 6.3%, respectively. Based on the results of the study, the test article is corrosive to the skin.