tert-pentylbenzene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 11 May to 06 June 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: ICCVAM: Current status of in vitro test methods for identifying ocular corrosives and severe irritants: The Bovine Corneal Opacity and Permeability (BCOP ) Test Method, March 2006

Deviations:

not applicable

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

tert-pentylbenzene

EC Number:

218-076-0

EC Name:

tert-pentylbenzene

Cas Number:

2049-95-8

Molecular formula:

C11H16

IUPAC Name:

(2-methylbutan-2-yl)benzene

Details on test material:

- Analytical purity: 97.4%
- Impurities: Cumene: 0.7%, Heptylbenzene (C13H18): 0.6%, Nonylbenzene (C15H22): 0.6%
- Lot/batch No.: Tank BV1112 du 18 avril 2007.

Test animals / tissue source

Species:

other: Bovine eyes

Details on test animals or tissues and environmental conditions:

TEST SYSTEM
- Test system: Bovine eyes from young cattle were obtained from the slaughterhouse
- Source: Vitelco, 's Hertogenbosch, The Netherlands

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 32 +/- 1°C

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl of the control or test substance was introduced onto the epithelium of the cornea.

Duration of treatment / exposure:

The Corneas were incubated for 10 +/- 1 minutes.

Number of animals or in vitro replicates:

Three corneas were selected at random for each treatment group.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the incubation the control or test substance was removed and the epithelium was washed at least three times with cMEM (Eagle's Minimum Essential Medium).

SCORING SYSTEM: Opacity determinations were performed on the corneas using a opacitometer. The change in opacity for each individual cornea (including the negative control) was calculated by subtracting the initial opacity reading from the final post-treatment reading. Following the final opacity measurement, permeability of the cornea was evaluated. The mean opacity and mean permeability values were used for each treatment group to calculate an in vitro score. If this in-vitro score ranges between 0-3 the test substance is non-irritant. If the in-vitro score is >80 the test substance is very severe irritant.

Results and discussion

In vitro

Results

Irritation parameter:

cornea opacity score

Run / experiment:

10 minutes (topical application)

Value:

ca. 1

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

See Table 1. The in vitro irritancy scores of the corneas treated with Tertiary-amylbenzene ranged from 0.2 to 1.7 with a mean of 1.0. Since all in vitr scores were less than 3.1 Tertiary-amylbenzene was considered non-irritant.
Based on the results obtained with the negative and positive control, it can be concluded that the test conditions were adequate and the test system functioned properly.

Any other information on results incl. tables

Table 1: Summary of opacity, permeability and in vitro scores

Treatment	Mean opacity	Mean permeability	Mean in vitro score
Negative control	0	-0.001	0.0
Positive control	87	6.170	179
Tertiary-amylbenzene	0	0.046	1.0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions of this study, Tertiary-amylbenzene is non irritant in the Bovine Corneal Opacity and Permeability according to EU criteria.

Executive summary:

Screening for the eye irritancy potential of Tertiary-amylbenzene using the Bovine Corneal Opacity and Permeability test (BCOP test) was performed. The possible ocular irritancy of Tertiary-amylbenzene was tested through topical application for 10 minutes. The test substance was applied undiluted (750 µL) directly on top of the corneas.

The mean in vitro irritancy score obtained with the negative control was less than 3.1 indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (10% w/v Benzalkonium chloride) was within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

The in vitro irritancy scores of the corneas treated with Teritiary-amylbenzene ranged from 0.2 to 1.7 with a mean of 1.0. Since all in vitro irritancy scores were less than 3.1, Tertiary-amylbenzene was considered non-irritant.

Under the test conditions of this study, it is concluded that this test is valid and that Tertiary-amylbenzene is non-irritant in the Bovine Corneal Opacity and Permeability according to EU criteria.