Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From May 11 to June 22, 2015.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test method according to OECD Guideline 430, EU Method B.40 and GLP study.

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:
OECD Guideline 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): 4-Aminoquinaldine.
- Chemical name: 4-amino-2-methylquinoline.
- Physical state: slightly yellow powder.
- Analytical purity: 98.1%
- Purity test date: April 13, 2015.
- Lot/batch No.: 83
- Expiration date of the lot/batch: April 2018.
- Storage condition of test material: 15-25ºC.

Test animals

Species:
rat
Strain:
Wistar
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Centre for Experimental Medicine (Medical University in Katowice).
- Age at study initiation: 20 days old.
- Housing: Plastic cage covered with a wire bar lid, of 58 x 37 x 21 cm. UV-sterilised wood shavings were used as bedding.
- Diet (e.g. ad libitum): Murigran (batch number 3/15) standard granulated laboratory fodder ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: 3 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 ºC.
- Humidity (%): 44-89 %.
- Air changes (per hr): about 16 times/hour.
- Photoperiod (hrs dark / hrs light): 12 hours/12h light.

Test system

Type of coverage:
other:
Preparation of test site:
shaved
Vehicle:
water
Remarks:
distilled water
Controls:
yes
Amount / concentration applied:
VEHICLE
- Amount(s) applied (volume or weight with unit): Distilled water (150 μL).
Duration of treatment / exposure:
24 h
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: The skin disc were removed from the dorsal and flank areas.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test item and the control items were removed by washing with a jet of tap water at up to 30ºC.
- Time after start of exposure: 24h

SCORING SYSTEM:
The test item is considered to be non-corrosive to skin if:
- the mean TER value obtained for the test item is greater than 5 kΩ, or
- the mean TER value is less than or equal to 5 kΩ, and the skin disc shows no obvious damage.
The test item is considered to be corrosive to skin if:
- the mean TER value obtained for the test item is less than or equal to 5 kΩ and
- the skin disc is obviously damaged.

Results and discussion

In vivo

Irritant / corrosive response data:
The gross examination showed that the positive control skin discs exhibited skin perforation, whereas the negative control skin discs and the ones treated with the test item did not reveal any changes.

Any other information on results incl. tables

Table 1. Results of the transcutaneous electrical resistance test (TER).

Animal number

Tested substance

Skin disc number

TER value(kΩ)

Mean TER value± SD (kΩ)

1

Positive control – 36 % HCl

1

0.89

0.89 ± 0.01

2

0.90

3

0.89

Negative control – distilled water

1

19.68

19.56 ± 0.27

2

19.25

3

19.75

Test item

1

5.68

5.91 ± 0.29

2

5.81

3

6.23

2

Positive control – 36% HCl

1

0.90

0.90 ± 0.01

2

0.91

3

0.90

Negative control – distilled water

1

16.58

16.91 ± 0.31

2

17.20

3

16.95

Test item

1

6.68

6.81 ± 0.18

2

6.73

3

7.01

Table 2. Gross changes on the surface of the treated skin discs.

Animal number

Tested substance

Skin disc number

Gross changes

1

Positive control –

36% HCl

1

Perforation

2

Perforation

3

Perforation

Negative control – distilled water

 

1

No changes

2

No changes

3

No changes

Test item

 

1

No changes

2

No changes

3

No changes

2

Positive control –

36% HCl

1

Perforation

2

Perforation

3

Perforation

Negative control – distilled water

 

1

No changes

2

No changes

3

No changes

Test item

 

1

No changes

2

No changes

3

No changes

The gross examination showed that the positive control skin discs exhibited skin perforation, whereas the negative control skin discs and the ones treated with the test item did not reveal any changes.

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item did not induce skin corrosion/severe irritation effects in this in vitro TER skin corrosion test.
Executive summary:

The in vitro skin corrosion test (transcutaneous electrical resistance), was performed according to OECD Guideline 430, EU method B.40 and followed GLP principles. The skin discs used in the experiment were obtained from 2 young female Wistar rats (28 -day-old animals). The electrical resistance of the skin discs measured before the start of the experiment was greater 10 kΩ. Three skin discs obtained from each animal were used for the test item and three for each control item. The test item was applied to the epidermal surface of the skin placed in a tube for 24h. Positive (36% hydrochloric acid) and negative (distilled water) controls were conducted concurrently. After removing the test item (or control item), the surface tension of the skin was reduced with a solution of ethanol, and after that a solution of MgSO4 was applied to hydrate the skin. Then the electrical resistance of the skin was measured placing the databridge electrodes on either side of the skin disc. The mean TER results were 5.91 and 6.81 kΩ (both higher than 5 kΩ). After that, the MgSO4 solution was removed and gross examination of the skin did not detect visible changes. In conclusion, the test item was not considered to lead to skin corrosion/severe irritation under the test conditions.