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Administrative data

Description of key information

Test material was slightly irritating to the skin and eye in the key studies.  For the skin, mean erythema and edema scores were 0.8 and 0.5, respectively.  The mean eye score was 0.4.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 Nov 2006 - 9 March 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted under GLP
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Medical University of Silesia, Katowice
- Age at study initiation: 3.5-4.5 months
- Weight at study initiation: 2.6-3.4 kg
- Housing: Individual metal cage
- 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): 20-22
- Humidity (%): 35-70
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: Not stated
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
Observations of skin were performed after 1, 24, 48 and 72 hours as well as 7 days since the end of exposure.
Number of animals:
3
Details on study design:
The undiluted test material was applied in volume of 0.5 mL to multilayered gauze patch with dimensions of 2.5 x 2.5 cm and then laid on the prepared skin of one rabbit (rabbit No 1). The area of skin surface treated with the test material was about 6 cm2. The gauze patches were covered with PCV foil and fixed with sticking plaster. The rabbit’s trunk was covered with lignin and elastic bandage was used to make circular protecting band. After 4 hours exposure time, the band and gauze patches were taken off and the residual test material was removed using water.

Following evaluation of the exposed skin and to confirm the obtained results the test material was administered to skin of the next two rabbits (rabbit No 2 and No 3) for four hours. The procedure was the same as in case of rabbit No 1.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4

Rabbit

No

Observation

type 1 hour

24

hours

48

hours

72

hours

7 days

Average

after 24,

48 and 72

hours

erythema 1 1 1 0 - 0.7

1

edema 0 0 0 0 - 0

erythema 1 1 1 0 - 0.7

2

edema 0 0 0 0 - 0

erythema 1 1 1 1 0 1

3

edema 0 0 0 0 0 0

Interpretation of results:
slightly 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 skin of rabbits.
Executive summary:

Acute skin irritation/skin corrosion 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 the OECD Guideline for Testing of Chemicals No 404/EU Method B.4 as well as Principles of Good Laboratory Practice (GLP, OECD 1997). The study was performed with white rabbits of New Zealand strain. The undiluted test material was administered in volume of 0.5 mL as a single dose to shaved skin of three rabbits and covered with appropriate band. The exposure time was 4 hours. After 1, 24, 48 and 72 hours as well as 7 and 14 days since the end of exposure time

skin condition was examined.

During observation all test rabbits showed changes on skin in a form of erythema. Classification of the test material was performed according to Annex to Decree of Ministry of Health of September 2nd, 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 skin of rabbits.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
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
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
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
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Test material was slightly irritating to the skin and eye in the key studies. For the skin, mean erythema and edema scores were 0.8 and 0.5, respectively. The mean eye score was 0.4.

One dermal study had slightly higher scores while the remainder were comparable or less than the key study.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Because the tests on the substance resulted in irritation consistent with Category 2 for both eye and skin, the substance will be classified as irritant.