Isobutyl phenylacetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 August 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to 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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Isobutyl phenylacetate

EC Number:

203-007-9

EC Name:

Isobutyl phenylacetate

Cas Number:

102-13-6

Molecular formula:

C12H16O2

IUPAC Name:

isobutyl phenylacetate

Test material form:

liquid

Details on test material:

Identification: Isobutyl Phenyl Acetate
Chemical nature: 2-methylpropyl 2-phenylacetate
EC No.: 203-007-9
CAS No.: 102-13-6
Molecular weight: 192.2 g/mol
Appearance/physical description: clear, colourless liquid
Empirical formula: C12H16O2
Batch No: SC00010162
Purity: 100%

Test animals / tissue source

Species:

other: Bovine eyes were used from adult cattle. They were transported to the test facility on the day of slaughter and used within 24hrs of receipt.

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Eyes from adult cattle (typically 12 to 60 months old) were obtained from a local abattoir as a by-product from freshly slaughtered animals. The eyes were excised by an abattoir employee after slaughter, and were placed in Hanks' Balanced Salt Solution (HBSS) supplemented with antibiotics (penicillin at 100 IU/mL and streptomycin at 100 µg/mL). They were transported to the test facility over ice packs on the same day of slaughter. The corneas were refrigerated on arrival and used within 24 hours of receipt.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

1.5

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD492 value)

Applicant's summary and conclusion

Interpretation of results:

other:

Remarks:

Not requiring classification

Conclusions:

No category. Not requiring classification to UN GHS or EU CLP.

Executive summary:

Corneal Epithelium Condition.

The corneas treated with the test item were clear post treatment and cloudy post incubation. The corneas treated with the negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation.

Criteria for an Acceptable Test.

The positive control In Vitro Irritancy Score was within the range 27.8 to 51.0. The positive control accepatnace criterion was therefore satisfied.

The negative control gave an opacity of >=4.7 and permeability <=0.080. The negative control accepatance criteria were therefore satisfied.

Conclusion.

No category. Not requiring classification to UN GHS or EU CLP.