Cyclohexanaminium, N,N,N-trimethyl-, hydroxide (1:1)

Endpoint summary

Description of key information

Skin irritation: corrosive

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin corrosion: in vitro / ex vivo

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

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test system:

artificial membrane barrier model

Vehicle:

unchanged (no vehicle)

Details on test system:

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.
test substance. Four vials containing the CDS were used for the test substance. 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 (see table in section 3.8) 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.

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): 500 µl

Duration of treatment / exposure:

up to 4 hours or unitl break through

Duration of post-treatment incubation (if applicable):

Test substance: 3 min to 4 hours or until break through
Negative control: 60 min
Positive control: continuosly until break through

Irritation / corrosion parameter:

penetration time (in minutes)

Run / experiment:

mean

Value:

15.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Breakthrough 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
14/0211-1	19 min	14 min	15 min	14 min	15:30
Controls:
PC: Sodium hydroxide, solid	11:20	-	-	-	-
NC: 10% citric acid	NB	-	-	-	-

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

Based on the observed results and applying the evaluation criteria it was concluded, that Trimethylcyclohexylammonium hydroxid, aqueous solution 50 wt.% shows a corrosive potential in the Corrositex® - Skin Corrosion Test under the test conditions chosen. The mean break through time determined in the in vitro membrane barrier test was 15 minutes and 30 seconds.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In vitro skin irritation:

The potential of Trimethylcyclohexylammonium hydroxid, aqueous solution 50 wt.% to cause dermal corrosion was assessed by a single topical application of 500 μL of the test substance to the Corrositex® Biobarrier Membrane (Corrositex® assay). The Corrositex® Biobarrier Membrane is the test system consisting of a reconstituted collagen matrix. The assay is based on the time that is required for the test substance to penetrate through the Corrositex® Biobarrier Membrane and produce a change in the Chemical Detection System (CDS). In the main test four Corrositex® Biobarrier Membranes were treated with the test substance. The mean break through time of the test substance, determined in the actual Corrositex® assay, was 15 minutes and 30 seconds. Based on the observed results and applying the evaluation criteria it was concluded, that Trimethylcyclohexylammonium hydroxid, aqueous solution 50 wt.% shows a corrosive potential in the Corrositex® - Skin Corrosion Test under the test conditions chosen.

Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification

Based on the results of the skin irritation porpertie, the test item is classified as skin corrosive cat. 1B (H314) according to Regulation (EC) No 1272/2008 (CLP).