3-cyclohexylaminopropylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03. June 2020 to 09. July 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

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

Test material information

Constituent 1

Reference substance name:

3-cyclohexylaminopropylamine

EC Number:

222-001-7

EC Name:

3-cyclohexylaminopropylamine

Cas Number:

3312-60-5

Molecular formula:

C9H20N2

IUPAC Name:

N1-cyclohexylpropane-1,3-diamine

Test material form:

liquid

Details on test material:

3-Cyclohexylaminopropylamine from Evonik Corporation, Batch: 2266445

In vitro test system

Test system:

other: synthetic biobarriers

Justification for test system used:

150 μl of the test article were added to the CDS reagent in a Qualify vial, and the vial
was observed for any notable color change. An observable color change indicates that the test article is compatible with the Corrositex® system

Details on test system:

TEST SYSTEM
Identity : Corrositex®Kit
Supplied by : InVitro International, Placentia, CA
Lot Numbers : CT 110419, CT 040119
Dates Received : 01 May 2020, 12 Jun 2020
Expiration Dates : Nov 2021, Apr 2021
Storage : Biobarriers – refrigerated at 2-8ºC.
Other kit components – room temperature and humidity

QUALIFICATION
For each test article, 150 μl of the test article were added to the CDS reagent in a Qualify vial, and the vial was observed for any notable color change. An observable color change indicates that the test article is compatible with the Corrositex® system.

METHOD
- The test articles were qualified and found to be compatible with the Corrositex® test system.
- The test articles were categorized by pH.
- For each test article, 500 µl of the test article were added to the Corrositex® test vials containing biobarriers and the time required for each test article to destroy the biobarrier was recorded.
- A Positive Control (1.0 N Sodium Hydroxide) and a
- Negative Control (1 % Citric Acid) were tested concurrently.
The mean breakthrough lime, which predicts the in vivo corrosive potential of each test article, was used to designate the United Nations (U.N.) Packing Group classifications.

CATEGORISATION
Next, each test article was categorized, which determined cut-off times for the Packing Group designations. A 10% formulation of each test article was prepared and its pH was measured. If the pH of the 10% formulation was <7.0, 150 μl of the neat test article were added to Vial A. The pH of Vial A was then measured, and if it was < 5.0, the test article was assigned to Category 1, and if it was >5.0, the test article was assigned to Category 2. If the pH of the 10% formulation was > 7.0, 150 μl of the neat test article were added to Vial B. The pH of Vial B was measured, and if the final pH was > 9.0, the test article was Category 1, and if it was < 9.0, the test article was Category 2.

CLASSIFICATION
Finally, each test article was classified to determine the Packing Group by adding 500 μl of the test article to each of four test vials containing biobarriers. If the test article penetrates or destroys the biobarrier, it will come in contact with the CDS reagent in the vial and induce a color change similar to that observed in the Qualify vial. The amount of time required for the test article to penetrate or destroy each biobarrier was recorded and the mean time of the four replicates was used to designate the United Nations (U.N.) Packing Group classification and GHS Sub-category as described below. A positive control was performed using 1.0 N sodium hydroxide. The result for the positive control is considered valid if it falls within the range of the MB Research historical mean ± 2 standard deviations. A negative control was performed using 1% citric acid; the result is considered valid if the breakthrough time is greater than 60 minutes.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

500 µl

Duration of treatment / exposure:

42,02/ 46,30/ 45,47/ 42,95 min = mean time 44,19 min

Number of replicates:

4

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

penetration time (in minutes)

Value:

44.19

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: CATEGORISATION: pH of 10 % solution =12, pH in vial B = 12, Category 1; CLASSIFICATION: Packing group II, moderate corrosivity, GHS Sub Category 1B

Any other information on results incl. tables

	Breakthrough Time (minutes)
Category 1	0 to 3 min	> 3 to 60 min	> 60 to 240 min	> 240 min
Category 2	0 to 3 min	> 3 to 30 min	> 30 to 60 min	> 60 min
	Packing Group I	Packing Group II	Packing Group III	Non-corrosive
	Severe Corrosivity	Moderate Corrosivity	Mild Corrosivity
	GHS Sub-category 1A	GHS Sub-category 1B	GHS Sub-category 1C

Applicant's summary and conclusion

Conclusions:

A Corrositex test with test item resulted in a mean breakthrough time of 44,12 min, and assignment of GHS Category 1B skin corrosivity and UN packaging group II classifications.

Executive summary:

The test articles were analyzed using the Corrositex® test method to determine their dermal corrosivity potential and Packing Group designations.

The 1.0 N Sodium Hydroxide Positive Control had a breakthrough lime of 20,3 and 18,47 minutes, which fell within the range allowed (>13.6 and <22.0 minutes).

The 1% Citric Acid Negative Control had a breakthrough time of >70,03 ans 65,73 minutes, which met the acceptance criterion of >60 minutes.

The results of this study indicated that the test articles were compatible with the Corrositex® system. The mean times required to destroy the synthetic biobarriers and the Packing Group classifications of these test articles are listed in Tables below.

 

Categorization Results

 

Test Article ldentity	Conc. Tested	pH of 10% (v/v) solution	pH in Tube B		Category
Test item	10%	12	12		1

 

Classification Results

 

Test Article ldentity	BreakthroughTime (minutes)					Packing Group			Corrosivity   Mild
	1	2	3	4	Mean
Test item	42,02	46,30	45,47	42,95	44,19	Packing Group II

 

 

 

 

Conclusion:

A Corrositex test with test item resulted in a mean breakthrough time of 44,19 min, and assignment of GHS Category 1B skin corrosivity and UN packaging group II classifications.