Registration Dossier

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:
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. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
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.