reaction products of diglycidyl ether bisphenol F (DGEBF) and oligomeric phenol diglycidyl ethers with acrylic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 24th April 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

30 May 2008

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

reaction products of diglycidyl ether bisphenol F (DGEBF) and oligomeric phenol diglycidyl ethers with acrylic acid

EC Number:

700-487-6

Molecular formula:

Not applicable.

IUPAC Name:

reaction products of diglycidyl ether bisphenol F (DGEBF) and oligomeric phenol diglycidyl ethers with acrylic acid

Details on test material:

- Name of test material (as cited in study report): Epoxy half acrylate
- Analytical purity: 100%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 13-14 weeks
- Weight at study initiation: 2518 - 2820 g
- Housing: individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): Pelleted standard Teklad Global High Fiber Rabbit Diet 2031C, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not given
- Humidity (%): not given
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the right eye remained untreated and served as the reference control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

eyes were not rinsed after application

Observation period (in vivo):

7 d

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes were not rinsed after application

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

4

Remarks on result:

other: hair loss and scabs were observed on the eye left of animal #1 from day 2 to 6 after instillation of test item, this was considered to be due to eye scratching

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The instillation of the test item into the eye resulted in slight to moderate ocular
discharges at the 1 hours observation (grade 1 in two animals and grade 2 in one animal). These effects were reversible: slight discharge was still observed at the 24 h observation in one animal, but was no longer evident after 48 h. No other eye reactions were observed.

Other effects:

No intercurrent deaths occurred during the course of the study. Hair loss and scabs were observed on the eye left of one animal (animal no. 1) from day 2 to 6 after instillation of test item, this was considered to be due to the eye scratching. No clinical signs were observed in any other animal during the study.
The body weight of the animals was within the range commonly recorded for this strain and age.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

In this study, Epoxy half acrylate was not irritating to the eye.

Executive summary:

In a primary eye irritation study according to OECD Guideline 405 (24 April 2002) and EU method B.5 (30 May 2008), 0.1 mL of Epoxy half acrylate (100% a.i.) was instilled into the conjunctival sac of the right eye of 3 female young adult New Zealand White rabbits. The eyes were not rinsed afterwards. Animals then were observed for up to 7 days.  Irritation was scored by the method of Draize.

The instillation of the test item into the eye resulted in slight to moderate ocular discharges at the 1 hours observation (grade 1 in two animals and grade 2 in one animal). These effects were reversible: slight discharge was still observed at the 24 h observation in one animal, but was no longer evident after 48 h. No other eye reactions were observed.

In this study, Epoxy half acrylate was not irritating to the eye.