Isooctyl palmitate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Test guideline 1

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)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.47 (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:

Isooctyl palmitate

EC Number:

215-675-9

EC Name:

Isooctyl palmitate

Cas Number:

1341-38-4

Molecular formula:

C24H48O2

IUPAC Name:

6-methylheptyl hexadecanoate

Test material form:

liquid

Remarks:

a colourless liquid

Test animals / tissue source

Species:

cattle

Strain:

other: slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany

Details on test animals or tissues and environmental conditions:

Species Bos primigenius Taurus (fresh bovine corneas)

Test system

Vehicle:

not specified

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

750 µL

Duration of treatment / exposure:

10 minutes at 32 ± 1 °C

Duration of post- treatment incubation (in vitro):

2 hours at 32 ± 1 °C

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

ca. 0.68

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

According to the guideline, the test is considered as valid if the positive control causes an IVIS that falls within two standard deviations of the current historical mean.
The mean IVIS of the negative control has to show an IVIS ≤ 3.
The validity criteria and findings are given in the following table:
Table 9.3 a Validity
Parameter Criterion Found Assessment
Mean IVIS of negative control
HBSS ≤ 3 0.34 ok
Mean IVIS of positive control
DMF undiluted 52.38 – 138.06 116.71 ok

Values for negative and positive controls were within the range of historical data of the test facility (see Annex 2, page 21). Therefore, the test system was acceptable.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the test item 1341-38-4 Isooctyl palmitate showed no effects on the cornea of the bovine eye. The calculated mean IVIS was 0.68.
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.