2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane

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 conducted under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane

EC Number:

500-033-5

EC Name:

4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane

Cas Number:

25068-38-6

Molecular formula:

(C15 H16 O2 . C3 H5 Cl O)x

IUPAC Name:

4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Institute of Occupational Medicine, Lodz
- Age at study initiation: 3.5 months
- Weight at study initiation: 3-3.1 kg
- Housing: Individual metal cages
- Diet (e.g. ad libitum): standard granulated fodder "LSK" produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 30-60
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 29.01.2007 To: 12.02.2007

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

Single treatment

Observation period (in vivo):

After 1, 24, 48 and 72 hours, and 7 days since administration of the test material condition of cornea, iris and conjunctiva was evaluated.

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritant / corrosive response data:

During observation after 24 hours since the test material administration the following changes in eye conjunctiva were stated: in rabbit No 1 and 2 – redness in form of some blood vessels hyperaemia (injection); in rabbit No 3 – diffuse crimson redness. The congestion of third eyelid in all test rabbits was stated whereas circumocorneal hyperaemia was noticed in rabbit No 1 and 3. The swelling of third eyelid was stated
in rabbit No 1. The rabbit No 3 showed swelling of conjunctiva and third eyelid. Additionally in rabbit No 1 the slight volume of excretion was stated while in rabbit No 3 the excretion on eyelids and eyelids hair was observed.

During observation after 48 hours since administration of the test material no pathological changes in rabbit No 2 were stated. In conjunctiva of rabbit No 1 the redness in form of some blood vessels hyperaemia (injection) was stated. In conjunctiva of rabbit No 3 the diffuse crimson redness and circumcorneal hyperaemia were observed. Furthermore, in rabbits No 1 and 3 the swelling of third eyelid and slight volume of excretion were stated.

During observation after 72 hours since administration of the test material in conjunctiva of rabbit No 1 and 3 the redness in form of some blood vessels hyperaemia (injection) and congestion of third eyelid were noticed. The rabbit No 3 showed also the swelling of third eyelid.

Other effects:

During observation after 7 days since administration of the test material no pathological changes in test rabbits were stated.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Epidian 6 – epoxy resin with an average molecular mass <= 700 does not irritate eyes of the rabbits.

Executive summary:

Acute eye irritation study of Epidian 6 – epoxy resin with an average molecular mass < 700 to rabbits was performed according to the agreement with Zakłady Chemiczne ORGANIKA – SARZYNA S.A., Nowa Sarzyna. The study was coded OS-

29/06.

The methodological basis was OECD Guideline for Testing of Chemicals No 405/ EU Method B.5 as well as Principles of Good Laboratory Practice (GLP, OECD 1997).

The study was performed with three white rabbits of New Zealand strain. The test material was administered in volume of 0.1 mL to conjunctival sac of one eye to each rabbit. After 1, 24, 48 and 72 hours and 7 days since administration of the test material, condition of cornea, iris and conjunctiva was evaluated.

After administration of the test material, during the observations, changes in conjunctival sac of rabbits eyes were noticed.

Classification of the test material was performed according to Annex to Decree of Ministry of Health of September 2, 2003 (Acts Daily No 171, Position 1666). Taking into account the obtained results, one may say that Epidian 6 – epoxy resin with an average molecular mass < 700 does not irritate eyes of rabbits.