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Toxicological information

Eye irritation

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

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

Resultsopen allclose all
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
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
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 d
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
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
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
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
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.