1,1'-(1-phenylethane-1,1-diyl)bis[4-(heptyloxy)benzene]

Endpoint summary

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

Reference

Reference 1

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Deviations:

no

GLP compliance:

yes

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 validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: No indication of corrosion.

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1-hour exposure

Value:

94

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

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.

 

Reference 2

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)

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

GLP compliance:

yes

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 validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

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)

Qualifier:

according to guideline

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

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 validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

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

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.