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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 May 2016 to 10 June 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
other: Epidermis keratinocytes
Cell source:
other: MatTek Corporation, Ashland MA, U.S.A.
Justification for test system used:
Recommended test system in international guidelines (OECD and EC).
Vehicle:
unchanged (no vehicle)
Details on test system:
EpiDerm Skin Model (EPI-200, Lot no.: 23953 kit KK and LL.
The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing
intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
50µl of undiluted test sample and each of the positive and negative controls.
Duration of treatment / exposure:
3-minute and 1-hour.
Duration of post-treatment incubation (if applicable):
3 hours at 37°C in air containing 5% CO2.
Number of replicates:
4 tissues per test item together with a negative control and positive control.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3-minute exposure
Value:
98
Vehicle controls valid:
not applicable
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: No indication of corrosion.
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1-hour exposure
Value:
94
Vehicle controls valid:
not applicable
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: No indication of corrosion.

Any other information on results incl. tables

   3-minute application viability (percentage of control)  1-hour application viability (percentage of control)
  Negative control   100   100
 Test item  98 94 
 Positive control  13  4
 

Applicant's summary and conclusion

Interpretation of results:
other: EU classification criteria not met
Conclusions:
4,4’-(1-phenylethane-1,1-diyl)bis(heptyloxybenzene) is a non-irritant and non-corrosive in the in vitro skin corrosion test under the conditions of this study.
Executive summary:

In an in vitro skin corrosion study human skin tissue (eipdermis keratinocytes) was exposed to undiluted 4,4'-(1 -phenylethane-1,1 -diyl)bis(heptyloxybenzene

for 3-minutes and 1-hour. There was 98% and 94% tissue viability following the 3-minutes and 1-hour exposure points, respectively. Resultantly, the test material is considered to be a non-irritant and non corrosive to skin.