Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
3-Aminomethyl-THF
IUPAC Name:
3-Aminomethyl-THF
Constituent 2
Chemical structure
Reference substance name:
1-(tetrahydrofuran-3-yl)methanamine
EC Number:
676-405-7
Cas Number:
165253-31-6
Molecular formula:
C5 H11 N O
IUPAC Name:
1-(tetrahydrofuran-3-yl)methanamine
Details on test material:
- Name of test material (as cited in study report): 3-Aminomethyl-THF
- Physical state: liquid
- Analytical purity: 99.9 corr. area%
- Lot/batch No.: 069/2013 Fr.3 Fl.2

Test animals

Species:
other: in vitro
Strain:
other: in vitro

Test system

Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µl
- Concentration (if solution): undiluted

Duration of treatment / exposure:
up to 4 hours or until break through
Observation period:
Test substance: 3 min to 4 hours or until break through
Negative control: 60 min
Positive control: continuosly until break through
Details on study design:
4 tests were performed for the test item, one test for the positive, negative ant eht color (blank) control.
The experimental design of this study consisted of a qualification screen with the CDS (to determine if a color change can be detected) and a categorization screen (to categorize weak acids/bases and strong acids/bases), which were performed as a pretest, and a definitive Corrositex® assay.
The Corrositex® assay was evaluated on the basis of the color change of the CDS. The time that a color change was observed was recorded manually and the break through times of the four replicates was used to determine the corrosive potential of the test substance. For the qualification screen, 150 μL of the test substance was added to the CDS screening tube. If the test substance failed to produce a color change in the CDS within one minute, the test substance could not be analyzed in this system, and no further testing was required. In addition, one vial was used for the PC, NC and for the color (blank) control, each. A membrane disc coated with the biobarrier matrix was placed into one vial containing the CDS and approximately 500 μL of the test substance was added onto the membrane disc. An electronic time clock was started with the application. The vial was observed for three minutes for any change in the CDS. If no color change was observed within three minutes, the remaining membranes were
treated with the test substance. An electronic time clock was started with each application. 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 break through of the test substance occurred. The elapsed time between test-substance application and the first change in the indicator solution (i.e. barrier
penetration) was recorded.

Results and discussion

Any other information on results incl. tables

 Break through times of the test substance and the PC and NC

 

Test substance

Break Through Time [min:s]

Vial 1

Vial 2

Vial 3

Vial 4

mean

13/0314-2

30:45

26:03

25:24

25:54

27:02

Controls:

 

PC:                                 Sodium hydroxide, solid

15:49

  -

  -

  -

NC:

10% citric acid

NB

  -

  -

  -

  -

NB = no breakthrough within maximum observation period (60 min)

For other abbreviations see list of abbreviations in section 6.

Based on the observed results and applying the evaluation criteria it was concluded, that 3-Aminomethyl-THF shows a corrosive potential2 in the Corrositex® - Skin Corrosion Test under the test conditions chosen. The mean breakthrough time determined in the in vitro membrane barrier test was 27 minutes and 2 seconds.

Applicant's summary and conclusion