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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
8-(butan-2-yl)-5,6,7,8-tetrahydroquinoline
EC Number:
938-871-2
Cas Number:
6613-31-6
Molecular formula:
C13H19N
IUPAC Name:
8-(butan-2-yl)-5,6,7,8-tetrahydroquinoline

Test animals

Species:
other: tissues of the human skin model EST-1000™

Test system

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
3 min and 1h

Results and discussion

Any other information on results incl. tables

This in vitro study was performed to assess the corrosive potential of GR-50-0572 by

means of the Human Skin Model Test.

Independent duplicate tissues of the human skin model EST-1000™ were exposed to the

test item, the negative control or the positive control for 3 minutes and 1 hour,

respectively. The experiment was performed under monochromatic yellow light.

The liquid test item (50 μL) was applied to each tissue and spread evenly over the surface

of the tissue.

A volume of 50 μL of either the negative control (deionised water) or the positive control

(8.0 N KOH) was applied to each tissue.

After exposure to the negative control the absorbance values exceeded the required

acceptability criterion of mean OD570 ≥ 0.8 for both treatment intervals thereby confirming

the acceptable quality of the tissues.

Exposure to the positive control induced a decrease in the relative absorbance as

compared to the negative control, both for the 3 minutes exposure period and for the 1

hour exposure period thus confirming the validity of the test system.

After exposure to the test item GR-50-0572 the relative absorbance values decreased to

90.3% after 3 minutes. After the 1 hour exposure relative absorbance values were

reduced to 60.8%. Nevertheless, both values did not exceed the threshold of 50% for the

3 minutes exposure and 15% for the 1 hour exposure. Therefore, the test item was not

considered to be corrosive.

In conclusion, it can be stated that in this study and under the reported experimental

conditions, the test item GR-50-0572 was non corrosive to skin according to UN GHS / EU

CLP Cat.1 / DSD (67/548/EEC).

Applicant's summary and conclusion

Interpretation of results:
other: further investigation is needed
Remarks:
Criteria used for interpretation of results: OECD GHS