Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

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)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl lactate
EC Number:
202-598-0
EC Name:
Ethyl lactate
Cas Number:
97-64-3
Molecular formula:
C5H10O3
IUPAC Name:
ethyl 2-hydroxypropanoate
Test material form:
liquid
Remarks:
colorless transparent 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:
The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container.

Test system

Vehicle:
not specified
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. 91.98
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
In the negative control, no signs of eye irritation were observed.
The positive control induced serious eye damage, which would be classified as GHS category I.
The test item Ethyl lactate induced serious eye damage on the cornea of the bovine eye. The calculated IVIS (In Vitro Irritancy Score)is 91.98.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
This in vitro study was performed to assess corneal damage potential of Ethyl lactate by quantitative measurements of changes in opacity and permeability in a bovine cornea.
The test item Ethyl lactate was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour 30 minutes and whose opacity had been determined. The test item was incubated on the cornea for
10 minutes at 32 ± 1 °C. After removal of the test item and 2 hours post-incubation, opacity and permeability values were measured.

The test item was tested pure.
Under the conditions of this test,the test item Ethyl lactate induced serious eye damage on the cornea of the bovine eye. The calculated IVIS (In Vitro Irritancy Score) is 91.98.
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS > 55 induces serious eye damage, that should be classified as UN GHS Category I.

No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.