Bis(4-(1,1,3,3-tetramethylbutyl)phenyl) ether

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experimental starting date 22 July 2020 Experimental Completion date 22 July 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Bis(4-(1,1,3,3-tetramethylbutyl)phenyl) ether

EC Number:

202-956-6

EC Name:

Bis(4-(1,1,3,3-tetramethylbutyl)phenyl) ether

Cas Number:

101-58-6

Molecular formula:

C28H42O

IUPAC Name:

1-(2,4,4-trimethylpentan-2-yl)-4-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]benzene

Test material form:

liquid

Specific details on test material used for the study:

Batch no. IPI0274/19

Test animals / tissue source

Species:

cattle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

750 µl

Duration of treatment / exposure:

10 minutes

Duration of post- treatment incubation (in vitro):

2 hours

Number of animals or in vitro replicates:

3

Details on study design:

One valid experiment was performed. Bovine corneas were used. They were collected from slaughtered cattle that were between 12 and 60 months old.
The test item Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)ether wasw applied onto the cornea of a bovine eye which had been previously incubated with cMEM without phenol at 32 +/- 1 °C for one hour and whose opacity hac been measured.
The test item was incubated on the cornea for 10 minutes at 32 +/- 1 °C. After removal of the test item and 2 hours post-incubation, opacity and permeability values were measured.
Hank's Balanced Solution (HBSS) was used as negative control. The negative control showed no irritating effect on the cornea and the calculated mean IVIS (In Vitro Ittitancy Score) was 0.15.
Dimethyl formamide (DMF) undiluted was used as positive control. The positive control in duced serious eye damage on the cornea and was within two standard deviations of the current historical mean. The calculated mean IVIS was 126.56

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

The IVIS of each replicate of the negative control was calculated from the following equation: IVIS = opacity difference + (15 x corrected OD492 value)

Value:

0.38

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the test item Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)ether showed no effects on the cornea of the bovine eye. The calculated mean IVIS was 0.38.

Executive summary:

One valid experiment was performed. Bovine corneas were used. They were collected from slaughtered cattle that were between 12 and 60 months old.
The test item Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)ether was applied onto the cornea of a bovine eye which had been previously incubated with cMEM without phenol at 32 +/- 1 °C for one hour and whose opacity hac been measured.
The test item was incubated on the cornea for 10 minutes at 32 +/- 1 °C. After removal of the test item and 2 hours post-incubation, opacity and permeability values were measured.
Hank's Balanced Solution (HBSS) was used as negative control. The negative control showed no irritating effect on the cornea and the calculated mean IVIS (In Vitro Ittitancy Score) was 0.15.
Dimethyl formamide (DMF) undiluted was used as positive control. The positive control in duced serious eye damage on the cornea and was within two standard deviations of the current historical mean. The calculated mean IVIS was 126.56.

According to OECD Guideline n. 437 (Oct. 2017), a substance with an IVIS </= 3 requires no classification for eye irritation or serious eye damage.