Fatty acids, linseed-oil, reaction products with bisphenol A-epichlorohydrin polymer and glycidyl neodecanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 01, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

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)

Deviations:

no

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of oxiran-2-ylmethyl 2,2,3,5-tetramethylhexanoate with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)

Molecular formula:

Not applicable (UVCB constituent)

IUPAC Name:

Reaction product of oxiran-2-ylmethyl 2,2,3,5-tetramethylhexanoate with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)

Constituent 2

Reference substance name:

Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:2)

Molecular formula:

Not applicable (UVCB constituent)

IUPAC Name:

Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:2)

Constituent 3

Reference substance name:

Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)

Constituent 4

Reference substance name:

Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:3)

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:3)

Constituent 5

Reference substance name:

High Mw components based on linseed oil fatty acids

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

High Mw components based on linseed oil fatty acids

Constituent 6

Reference substance name:

Sum of unassigned components

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Sum of unassigned components

Test material form:

liquid

Details on test material:

UVCB

Specific details on test material used for the study:

Batch no.: #210162718
Composition: reaction products of linseed-oil fatty acids, 4,4'Methylendiphenyldiglycidylether with neodecanoic fatty acid, oxiranylmethylester
Purity: 100 % as per definition of UVCB
Appearance: brown liquid

Test animals / tissue source

Species:

cattle

Strain:

other: Bos primigenius Taurus

Details on test animals or tissues and environmental conditions:

Bovine corneas were used. They were collected from slaughtered cattle (from Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany, on the day of the test) which were between 12 and 60 months old.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

750 µL (the “closed chamber-method” was used in this study, for liquid substances)

Duration of treatment / exposure:

10 min at 32 ± 1 °C

Duration of post- treatment incubation (in vitro):

2 hours

Number of animals or in vitro replicates:

3

Details on study design:

The test substance 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 substance was incubated on the cornea for 10 min at 32 ± 1 °C. After removal of the test substance and 2 h post-incubation, opacity and permeability values were measured

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

cornea opacity and permeability

Value:

0.44

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

Physiological sodium chloride solution was used as negative control and showed no irritating effect on the cornea and the calculated IVIS (in vitro irritancy score) was -0.79. Dimethylformamide (DMF) undiluted was used as positive control and induced serious eye damage on the cornea and fell within two standard deviations of the current historical mean. The calculated IVIS (in vitro irritancy score) was 96.29.
Under the conditions of this study, the test substance showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) was 0.44. According to OECD Guideline no. 437, a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Remarks:

does not require classification

Conclusions:

Under the study conditions, the test substance was not irritating to bovine eye (BCOP test).

Executive summary:

A study was conducted to determine the in vitro eye irritation potential of the test substance according to OECD Guideline 437 and EU Method B.47 (BCOP test), in complinace with GLP. Bovine eyes were exposed to 750 µL undiluted test substance for 10 min (in triplicates). After removal of the test substance and 2 h post-incubation, opacity and permeability values were measured and reported as the in vitro irritancy score (IVIS). Physiological sodium chloride solution was used as negative control and dimethylformamide (DMF) undiluted as positive control. Physiological sodium chloride solution showed no irritating effect on the cornea and the calculated IVIS was -0.79. DMF induced serious eye damage on the cornea and fell within two standard deviations of the current historical mean. The calculated IVIS was 96.29. The test substance showed no effects on the cornea of the bovine eye. The calculated IVIS was 0.44. All validity criteria were met. Under the study conditions, the test substance was not irritating to bovine eye (Andres, 2016).