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Description of key information

The results of an in vitro skin corrosion and skin irritation study employing human skin tissue (eipdermis keratinocytes) exposed to the undiluted substance indicates that the substance is a non-corrosive and non-irritant to human skin. The results of an in vitro eye corrosion/irritation study employing isolated bovine cornea exposed to the undiluted substance for 10-minutes indicates that the substance is a non-irritant to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

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
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Deviations:
no
GLP compliance:
yes
Test material information:
Composition 1
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.
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.

   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
 
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.

 

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 June 2016 to 27 June 2016
Reliability:
1 (reliable without restriction)
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes
Test material information:
Composition 1
Test system:
human skin model
Source species:
human
Cell type:
other: Epidermal keratinocytes
Cell source:
other: SkinEthic Laboratories, Lyon, France.
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Duration of treatment / exposure:
15 ± 0.5 minutes
Duration of post-treatment incubation (if applicable):
42 hours at 37°C
Number of replicates:
Three tissues per test item.
Irritation / corrosion parameter:
% tissue viability
Value:
88
Vehicle controls valid:
not applicable
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
no indication of irritation
Interpretation of results:
other: EU classification criteria not met
Conclusions:
4,4’-(1-phenylethane-1,1-diyl)bis(heptyloxybenzene) is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
Executive summary:

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

for 15-minutes. There was 88% tissue viability following the 15-minute exposure point. Resultantly, the test material is considered to be a non-irritant to the skin.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 April 2016 to 28 April 2016
Reliability:
1 (reliable without restriction)
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
yes
Remarks:
One of the negative control eyes was excluded from the analysis since a spot was present after the incubation which resulted in an IVIS >3. This result does not affect the study outcome.
GLP compliance:
yes
Test material information:
Composition 1
Species:
other: Bovine
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Isolated bovine cornea
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
750 μl
Duration of treatment / exposure:
10 ± 1 minutes at 32 ± 1°C
Duration of post- treatment incubation (in vitro):
120 ± 10 minutes at 32 ± 1°C
Irritation parameter:
in vitro irritation score
Value:
2.3
Vehicle controls valid:
not applicable
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
no indication of irritation
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material did not induce ocular irritation under the conditions of this study.
Executive summary:

In an in vitro eye corrosion/irritation study, isolated bovine cornea was exposed to undiluted substance for 10-minutes. The in vitro irritation score was 2.3% and so the substance is considered to be a non-irritant to the eye.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the findings of in vitro skin irritation and eye irritation studies conducted on the substance, classification of the substance for these health endpoints is not justified.