1-(4-tert-butylphenyl)-3-(4-methoxyphenyl)propane-1,3-diol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016-11-21 to 2017-03-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

Version / remarks:

28 July 2015

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: MaTTek Corporation: EpiOcular Eye Irritation Test (OCL-200-EIT) for the prediction of acute ocular irritation of chemicals

Version / remarks:

29 Hune 2015

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

R,R-1-(4-tert-butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol

Molecular formula:

C20H26O3

IUPAC Name:

R,R-1-(4-tert-butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol

Constituent 2

Reference substance name:

R,S-1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol

Molecular formula:

C20H26O3

IUPAC Name:

R,S-1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol

Constituent 3

Reference substance name:

S,S-1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol

Molecular formula:

C20H26O3

IUPAC Name:

S,S-1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol

Constituent 4

Reference substance name:

S,R-1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol

Molecular formula:

C20H26O3

IUPAC Name:

S,R-1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol

Test material form:

solid

Details on test material:

Minimum purity 95% w/w

Specific details on test material used for the study:

Name: Art. 132720 (RonaCare Pristine Bright)
Synonym: Avodiol
CAS-No.: 955359-35-0
Batch: EH16000620
Purity: 95 % (w/w) (HPLC)
Appearance: light cream, free flowing granules
Released until: 2018-06-30


PREPARATION OF THE TEST MATERIAL
The test item Art. 132720 was prepared as a 20% (w/v) suspension in a 0.9% sodium chloride solution. The stability in the vehicle was not investigated. The test item preparation was administered within <1 hour after preparation.

Test animals / tissue source

Details on test animals or tissues and environmental conditions:

CELL CULTURE
- Supplier: MatTek Corporation (82105 Bratislava, Slovakia)
- Source: human epidermal keratinocytes cultured to form a stratified squamous epithelium
- Format: 24 well plate
- Batch: 23757


TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment: 37°C
- Temperature of post-treatment incubation: 37°C

REMOVAL OF THE TEST MATERIAL AND CONTROL
After the end of the treatment interval, the residual test item was removed immediately by gently rinsing with a minimum volume of 25 mL DPBS using a pipette. Excess DPBS was removed by gently shaking the inserts and blotting the bottom with blotting paper.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST ITEM: 50 mg
NEGATIVE CONTROL: 50 µL (deionised water)
POSITIVE CONTROL: 50 µL (methyl acetate)

Duration of treatment / exposure:

6 h

Number of animals or in vitro replicates:

duplicate

Details on study design:

According to guideline

Results and discussion

In vitro

Results

Irritation parameter:

other: cell viability

Run / experiment:

mean value

Value:

3.3

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Any other information on results incl. tables

Group	Time / [h]	Mean Absorbance	Mean Relative viability / [%]
Negative Control	6	1.355	100
Positive Control	6	0.247	18.2
Test Item	6	0.044	3.3

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item possesses an eye irritating potential.