Benzene, (1-methylethyl)-, oxidized, polyphenyl residues

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to OECD guideline with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Benzene, (1-methylethyl)-, oxidized, polyphenyl residues

EC Number:

269-798-8

EC Name:

Benzene, (1-methylethyl)-, oxidized, polyphenyl residues

Cas Number:

68333-89-1

Molecular formula:

Cannot be given for UVCB

IUPAC Name:

not applicable

Test material form:

liquid: viscous

Details on test material:

black viscous liquid

Test animals / tissue source

Species:

other: Bos primigenius Taurus (fresh bovine corneas)

Details on test animals or tissues and environmental conditions:

Fresh bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Bir-kenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hank’s balanced salt solution (supplemented with 0.01% streptomycin and 0.01% penicillin). Then, the corneas were dissected and incubated in medium at 32 ± 1 °C in an incuba-tion chamber for 1 h.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent vehicle

Amount / concentration applied:

The test item is a liquid substance. It was tested directly, without dilution or preparation of a solution.

Duration of treatment / exposure:

see below

Observation period (in vivo):

2h

Number of animals or in vitro replicates:

3 replicates

Details on study design:

The test item High Boiler, Z-Oil was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 h and whose opacity had been measured. The test item was incubated on the cornea for 10 min at 32 ± 1 °C. After removal of the test item and 2 h post-incubation, opacity and permeability values were measured.
Physiological sodium chloride solution was used as negative control.
Dimethylformamide (DMF) undiluted was used as positive control.

Results and discussion

In vivo

Results

Irritation parameter:

other: IVIS (in vitro irritancy score)

Basis:

mean

Score:

5.34

Reversibility:

not specified

Remarks on result:

other: in vitro study

Irritant / corrosive response data:

Physiological sodium chloride solution was used as negative control. The negative control showed no irri-tating effect on the cornea and the calculated IVIS (in vitro irritancy score) is 0.79.
Dimethylformamide (DMF) undiluted was used as positive control. The positive control induced in two replicates serious eye damage on the cornea and falls within two standard deviations of the current histo-rical mean. The calculated IVIS (in vitro irritancy score) is 82.59.
Under the conditions of this study, the test item High Boiler, Z-Oil showed effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 5.34.

Any other information on results incl. tables

Physiological sodium chloride solution was used as negative control. The negative control showed no irri-tating effect on the cornea and the calculated IVIS (in vitro irritancy score) is 0.79.

Dimethylformamide (DMF) undiluted was used as positive control. The positive control induced in two replicates serious eye damage on the cornea and falls within two standard deviations of the current histo-rical mean. The calculated IVIS (in vitro irritancy score) is 82.59.

Under the conditions of this study, the test item High Boiler, Z-Oil showed effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 5.34.

Applicant's summary and conclusion

Interpretation of results:

other: No classification in an UN GHS Category for eye damage

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

Under the conditions of this study, the test item High Boiler, Z-Oil showed effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 5.34.
According to OECD Guideline no. 437, a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category for eye damage.

Executive summary:

The test item high boiler, Z-Oil was tested in Bovine corneas according to OECD 437. The corneas were collected from slaughtered cattle which were between 12 and 60 months old. The test item was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 h and whose opacity had been measured. The test item was incubated on the cornea for 10 minat32 ± 1 °C. After removal of the test item and 2 h post-incubation, opacity and permeability values were measured.