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Diss Factsheets

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: EU method B.40 BIS: "In Vitro Skin Corrosion: Human Skin Model Test
Deviations:
no
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

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

Resultsopen allclose all
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)
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.