1,1-dimethylprop-3-ynylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2017-01-17 to 2017-05-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2015-06-28

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: New guidance document on an integrated approach on testing and assessment (IATA) for skin corrosion and irritation, Series on Testing and Assessment No. 203

Version / remarks:

2014-07-11

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,1-dimethylprop-3-ynylamine

EC Number:

221-029-7

EC Name:

1,1-dimethylprop-3-ynylamine

Cas Number:

2978-58-7

Molecular formula:

C5H9N

IUPAC Name:

2-methylbut-3-yn-2-amine

Specific details on test material used for the study:

- Name (as cited in the study): Golpanol MPA
- Purity: 99.2 area%
- Batch Nr.: 85603856PO
- Batch Nr.:
- Contet: w(C5H9N) = 89.2 g/100 g
- Homogeneity: the test substance was homogeneous by visual inspection
- pH value: ca. 6
- Physical state / color: liquid / colorless, clear
- Storage conditions: room temperature

In vitro test system

Test system:

artificial membrane barrier model

Remarks:

Corrositex assay

Vehicle:

unchanged (no vehicle)

Details on test system:

The Corrositex® assay was conducted according to the methods described in the Corrositex® Instruction Manual, InVitro International, Irvine CA, USA and Transia GmbH, 35510 Butzbach, Germany 10 April 2016.

- Test kit: Corrositex®, InVitro International, Irvine CA, USA, containing: reagents required for qualification and categorization screen,
biobarrier matrix powder and diluent, membrane discs and vials containing the Chemical Detection System.
- Fume hood: The assay was run in a fume hood

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- amount applied: single topical application of 500µL test substance

VEHICLE
- test substance was applied undiluted

NEGATIVE CONTROL
- amount apllied: 500 µL 10% citric acid

POSITIVE CONTROL
- amount applied: one pellet of sodium hydroxide

Duration of treatment / exposure:

- min. 3 minutes, max. 60 minutes (negative control)

Number of replicates:

Four vials were used for the test substance and one vial for the positive control and negative control each.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Duration of treatment / exposure:

min. 3 minutes, max. 60 minutes (negative control)

Details on study design:

ACCEPTANCE CRITERIA
1. breakthrough time for the positive control substance was in the historic control range (mean ± 2-3x standard deviations)
2. negative control was not to induce membrance breakthrough within a 60-minute observation period.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

penetration time (in minutes)

Value:

7.01

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Other effects / acceptance of results:

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Range of historical values if different from the ones specified in the test guideline: breakthrough time of NaOH (solid, historical data) was 12.10 minutes.

Any other information on results incl. tables

Breakthrough times of the test substance, the negative control (NC) and positive control (PC). NB = no breakthrough within maximum observation period (60 minutes).

Test Substance	Break Through Time [min:s]
	Vial 1	Vial 2	Vial 3	Vial 4	Mean
	8:48	6:49	7:01	5:26	7:01
Controls:
PC: sodium hydroxide, solid	13:27	-	-	-	-
NC: 10% citric acid	NB	-	-	-	-

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria