terephtalic acid compound with diamines

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28-Sep-2015 to 02-Oct-2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EU method B.40 BIS: "In Vitro Skin Corrosion: Human Skin Model Test

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OECD Guideline, no. 431: In Vitro Skin Corrosion: Human Skin Model Test

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Reaction mixture of 1,4-Butanediamine, 1,6-Hexanediamine and 1,4-Benzenedicarboxylic acid
- Substance type:White crystalline powder
- Physical state: powder
- Storage condition of test material: At room temperature

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25.0 to 30.9 mg of the test substance was applied undiluted ( with 25 µl Milli-Q water to ensure close contactto the tissue)

NEGATIVE CONTOL:
- Amount(s) applied (volume or weight with unit): 50 µl Milli-Q water

POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 50 µl KOH
- Concentration (if solution): 8 N

Duration of treatment / exposure:

Exposure:3 minutes and 1 hour
Post incubation period: 42 hours

Details on study design:

TEST SITE
- Area of exposure: human skin model
- % coverage: 0.6 cm2

REMOVAL OF TEST SUBSTANCE
- Washing (if done): phosphate buffered saline
- Time after start of exposure: 3 minutes and 1 hour

POST INCUBATION PERIOD
- 42 hours

SCORING SYSTEM:
- After treatment the medium was replaced by 300 µl MTT-medium and tissues were incubated for
3 hours at 37°C in air containing 5% CO2. After incubation the tissues were washed with PBS and formazan was extracted with 2 ml isopropanol (MatTek corporation) over night at room temperature. The amount of extracted formazan was determined spectrophotometrically at 540 nm

In addition to the normal 1-hour procedure, one freeze-killed tissue treated with test substance and one freeze-killed non treated tissue was used for the cytotoxicity evaluation with MTT.

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: percentage viability

Value:

96

Remarks on result:

other:

Remarks:

Basis: other: percentage of control. Time point: 3 minutes. (migrated information)

Results 2

Irritation / corrosion parameter:

other: other: percentage of viability

Value:

83

Remarks on result:

other:

Remarks:

Basis: other: percentage of control. Time point: 1 hour. (migrated information)

Applicant's summary and conclusion

Interpretation of results:

other: not corrosive

Conclusions:

The in vitro skin irritation test was conducted according to OECD 431 guideline and GLP principles.

It is concluded that this test is valid and that Reaction mixture of 1,4-Butanediamine, 1,6-Hexanediamine and 1,4-Benzenedicarboxylic acid is not corrosive in the in vitro skin corrosion test.

Executive summary:

Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 96% and 83% respectively. Because the mean relative tissue viability for the test item was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment the test item is considered to be not corrosive.

The absolute mean OD₅₇₀(optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The mean relative tissue viability following 3-minute exposure to the positive control was 8%. The maximum inter-tissue variability in viability between two tissues treated identically was less than 5% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 3%. It was therefore concluded that the test system functioned properly.