Hexamethylenediamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and Guideline Study. No deviations were observed.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hexamethylenediamine

EC Number:

204-679-6

EC Name:

Hexamethylenediamine

Cas Number:

124-09-4

Molecular formula:

C6H16N2

IUPAC Name:

hexane-1,6-diamine

Details on test material:

- Name of test material (as cited in study report): 1.6-hexadiamine, H-22685, HMDA, 1.6-diaminohexane, 77H3446
- Substance type:
- Physical state: water-white solid
- Composition of test material, percentage of components: 99.9% Hexamethylene Diamine
- Lot/batch No.: no data
- Stability under test conditions: the test substance appeared to be stable under the conditions of the study, no evidence of instability was observed

Test animals

Species:

other: In Vitro International Corrositex assay kit

Details on test animals or test system and environmental conditions:

Not applicable

Test system

Type of coverage:

other: Biobarrier membrane or matrix discs

Vehicle:

water

Controls:

other: A Positive control vial for each concentration group contained 70% nitric acid and a negative control vial for each concentration group contained 10% citric acid.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500µL
- Concentration (if solution): 35 %, 70 % and 85 %

VEHICLE
- concentration : 65 %, 30 % and 15 %

Duration of treatment / exposure:

- 0 to 3 min
- > 3 to 60 min
- > 60 to 240 min
- > 240 min

Observation period:

Up to the test substance break through the membranes.

Number of animals:

No animals, in vitro

Details on study design:

The purpose of this study was to determine skin corrosion potential of 1,6-hexanediamine using the In Vitro International Corrositex assay kit. The results were used to determine the United Nations' Package Group. The study was based on the time required for the test substance to pass through a biobarrier membrane and produce a change in a chemical detection system.

Principles of Methodology:
Biobarrier membrane or matrix discs must be prepared and stored at 2-8ºC for at least 2 hours prior to conducting the assay. The Corrositex Biobarrier Membrane consisted of a reconstituted collagen matrix.

Protocol:
The three concentrations of H-22685 (35%, 70%, and 85%) were prepared by mixing the appropriate amount of test substance with deionized water approximately 30 minutes prior to conducting the assay. The biobarrier membrane discs were prepared 1 day prior to conducting the assay. The test substance was first tested to determine if the sample was compatible with the Corrositex system. Approximately 150 µL of the test substance was added to the Qualify test tube, shaken, and allowed to stand for 1 minute. A change in color or consistency was observed so Step 2 for categorization was initiated. Approximately 150 µL of test substance was added to test tubes labeled A (yellow solution) and B (clear solution). The test tubes were capped and shaken. A color change was noted for all three concentrations; the color was matched to the corresponding color charts on the Corrositex Testing Protocol Poster. The color change for each concentration corresponding to Category I. Step 3 for classification was then started. A membrane disc containing the biobarrier matrix was placed into a chemical detection system (CDS) vial. Approximately 150 µL of a 35% solution of 1,6-hexanediamine was pipetted on top of the discs. The vial was then observed for a change in the CDS. This procedure was followed for each of the 4 test vials. Step 3 was performed with a 70% concentration of 1,6-hexanediamine and with a 85% concentration of 1,6-hexanediamine. One vial for each test concentration was similarly treated with a positive control (70% nitric acid) and a negative control (10% citric acid). The time it took for the test substance to break through the membranes was documented. The mean value of the breakthrough time for all 4 vials was used in determining the package group.

Classification of category I Substances:
Greater than 3 to 60 minutes = Package Group II.

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

penetration time (in minutes)

Run / experiment:

vial 1 to 4

Value:

> 34 - < 44

Vehicle controls validity:

not specified

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other:

Remarks:

Results for 35% solution. Based on Corrositex Times. Remarks: The mean breakthrough time for all 4 vials was 39 minutes and 46 seconds.

Results 2

Irritation / corrosion parameter:

penetration time (in minutes)

Run / experiment:

vial 1 to 4

Value:

> 39 - < 40

Vehicle controls validity:

not specified

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other:

Remarks:

Results for 70% solution. Based on Corrositex Times. Remarks: The mean breakthrough time for all 4 vials was 39 minutes and 29 seconds.

Results 3

Irritation / corrosion parameter:

penetration time (in minutes)

Run / experiment:

vial 1 to 4

Value:

> 45 - <= 46

Vehicle controls validity:

not specified

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other:

Remarks:

Results for 85% solution. Based on Corrositex Times. Remarks: The mean breakthrough time for all 4 vials was 45 minutes and 49 seconds..

Any other information on results incl. tables

Table 7.3.1/2: Breakthrough of the biobarrier occurred as follows (hour:minute:second):

	35%	70%	85%
Vial 1	00 41 49	00 39 38	00 46 00
Vial 2	00 34 44	00 39 30	00 45 51
Vial 3	00 43 55	00 39 26	00 45 45
Vial 4	00 34 35	00 39 21	00 45 40
Mean Value	00 38 46	00 39 29	00 45 49
Vial 5 (Positive Control)	00 01 48	00 01 48	00 02 08
Vial 6 (Negative Control)	02 50 05	01 31 28	01 37 50

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this test, the 35%, 70% and 85% HMD aqueous solutions were corrosive and were assigned to Packing Group II. HMD is classified as Corrosif (C, R34) and in category 1B according to the CLP regulation (1272/2008).

Executive summary:

The purpose of this study was to determine skin corrosion potential of 1.6-hexadiamine (HMD) according to the OECD 435 (in vitro test) . Aqueous dilutions of HMD at 35%, 70% and 85% were evaluated for skin corrosion potential using the in vitro International Corrositex¿ assay. The results of the assay were used to determine the United Nations corrosive packing group. Corrositex is a standardized and quantitative in vitro corrosivity test. The model is based on the time required for the test substance to pass through a biobarrier membrane and produce a change in a chemical detection system.

For each concentration, appromately 150 µL was applied to each 4 membrane discs. The time each aliquot of test substance passed through the biobarrier membrane was documented. A mean breakthrough time was calculated for each concentration of HMD tested. The packing group designations were determined based on the Corrositex¿ category assigned and mean breakthrough times. All 3 concentrations of HMD were determined to be Category I.

A 35 % HMD concentration passed through all 4 of the membranes in less than 44 minutes. The mean breakthrough time for all 4 vials was 38 minutes and 46 seconds. A 70% concentration of the test substance passed through all 4 of the membranes in less than 47 minutes. The mean breakthrough time for all 4 vials was 39 minutes and 29 seconds. A 85% concentration of HMD passed through all 4 of the membranes in less than 45 minutes. The mean breakthrough time for all 4 vials was 45 minutes and 49 seconds.

Under the conditions of this test, the 35%, 70% and 85% aqueous solutions of HMD were corrosive and were assigned to Packing Group II. HMD is classified as Corrosif (C, R34) and in category 1B according to the CLP regulation (1272/2008).