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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin and eye irritation properties of asymmetrical epoxy amine adduct Reaction Product of Bisphenol A diglycidylether (BADGE) with IPDA and MXDA was assessed using a read across approach from data on symmetrical epoxy amine adducts Reaction products of IPDA with bisphenol A diglycidylether (BADGE) and Reaction products of MXDA with bisphenol A diglycidylether (BADGE), as these substances were considered to show similar toxicological properties. Based on the results obtained, Reaction Product of Bisphenol A diglycidylether (BADGE) with IPDA and MXDA was considered not irritating to skin and not irritating to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
from 2007-10-03 to 2007-12-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
2004/73/EC
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
August 1988
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: TETRABBIT Kft. 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: Young adult rabbits, 10 weeks old
- Weight at study initiation: 2834 - 3389 g
- Housing: Animals were housed individually in metal cages
- Diet: The animals received PURINA Base – Lap gr. diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum
- Water: The animals received as tap water from self-service water system ad libitum
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8 - 12 air exchange/hour by central air-condition system
- Photoperiod: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
- Concentration: None

VEHICLE
- Amount(s): None
Duration of treatment / exposure:
4 hours
Observation period:
Animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes, and then at 24, 48, 72 hours, then one week after the patch removal.
Number of animals:
3 male
Details on study design:
TEST SITE
- Area of exposure: approximately 6 cm² of intact skin
- % coverage: Not estimated
- Type of wrap if used: Plastic wrap for 4 hr

REMOVAL OF TEST SUBSTANCE
- Washing: Water of body temperature
- Time after start of exposure: 4 hr

SCORING SYSTEM: Draize (1959)
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
9143/M
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
9135/M
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
9139/M
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
9143/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
9135/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
9139/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight erythema in two animals (score 1), well defined erythema (score 2) in one animal. No edema in all animals. No irritation symptoms /erythema, edema, and/or other signs)) were observed after 1 week. Study was terminated one week after treatment.
Interpretation of results:
GHS criteria not met
Conclusions:
Reaction products of IPDA with bisphenol A diglycidylether (BADGE) was tested for skin irritation in rabbits. The observed symptoms were evaluated as fully reversible alterations.
Executive summary:

In this skin irritation study albino New Zealand White rabbits were treated with Reaction products of IPDA with bisphenol A diglycidylether (BADGE). The test item was applied to the intact skin of rabbits as a single dose of 0.5 g. The irritation symptoms were examined at 1, 24, 48 and 72 hours, then one week after the patch removal.

One hour after the patch removal in two animals very slight erythema (scores 1-1) and in one animal well defined erythema (score 2) was observed on the treated skin surfaces. There was no oedema observed during the study.

24 hours after the patch removal the degree of erythema did not change compared to the previous observation.

48 hours after the patch removal very slight erythema (scores 1-1-1) was found in all animals.

72 hours after the patch removal the irritation symptoms did not change compared to the previous observation.

1 week after the patch removal, no irritation symptoms (erythema, oedema and/or other signs) were observed in any of the animals. Thus, one week after the treatment the study was terminated.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) were as follows:

- erythema: 1, 1, 1.33

- edema: 0, 0, 0

During the study the control areas of all animals were symptom-free. During the study the general state and behaviour of all animals were normal. There were no notable body weight changes during the contact and observation period.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
from 2007-09-20 to 2007-12-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
2004/73/EEC
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: TETRABBIT Kft. 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: Young adult rabbits, 10 weeks old
- Weight at study initiation: 2747 - 2789 g
- Housing: Animals were housed individually in metal cages
- Diet: The animals received PURINA Base – Lap gr. diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum
- Water: The animals received as tap water from self-service water system ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes: 8 - 12 air exchange/hour by central air-condition system
- Photoperiod: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g

VEHICLE
None
Duration of treatment / exposure:
4 hr
Observation period:
Animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes, and then at 24, 48, 72 hours, then one and two weeks after the patch removal.
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm² of intact skin
- Type of wrap if used: Plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing: Water of body temperature
- Time after start of exposure: 4 hr

SCORING SYSTEM: Draize 1959
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
9138/M
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 2 weeks
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
9132/M
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 2 weeks
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
9145/M
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 2 weeks
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.56
Max. score:
4
Reversibility:
fully reversible within: 2 weeks
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
9138/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 2 weeks
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
9132/M
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 2 weeks
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
9145/M
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 2 weeks
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 2 weeks
Irritant / corrosive response data:
Very slight erythema in two animals (score 1 and 1.67), well defined erythema (score 2) in one animal. Very slight edema (score 0.33) in two animals, no edema in one animal. No irritation symptoms (erythema, edema, and/or other signs) were observed after 2 weeks. Study was terminated two weeks after treatment.
Interpretation of results:
GHS criteria not met
Conclusions:
Reaction products of MXDA with bisphenol A diglycidylether (BADGE) was tested for skin irritation in rabbits. Very slight to well defined erythema and very slight oedema could be detected. The observed symptoms were evaluated as fully reversible alterations.
Executive summary:

In this skin irritation study albino New Zealand White rabbits were treated with Reaction products of MXDA with bisphenol A diglycidylether (BADGE). The test item was applied to the intact skin of rabbits as a single dose of 0.5 g. The irritation symptoms were examined at 1, 24, 48 and 72 hours, then one and two weeks after the patch removal.

One hour after the patch removal no irritation symptoms (erythema, oedema and/or other signs) were observed in any of the animals.

24 hours after the patch removal in two animals (No.: 9138, 9145) very slight erythema (scores 1-1) and in one animal (No:. 9132) well defined erythema (score 2) was observed on the treated skin surfaces. In two animals (No.: 9132, 9145) very slight oedema (scores 1-1) appeared at this time.

48 hours after the patch removal no oedema was found on the treated skin surfaces of animals. In two animals (No.: 9132, 9145) well defined (scores 2-2) in one case (No.: 9138) very slight erythema (score 1) was found.

72 hours after the patch removal the irritation symptoms did not change compared to the previous observation.

1 week after the patch removal, very slight erythema (scores 1-1-1) was found in all animals.

2 weeks after the patch removal, no irritation symptoms (erythema, oedema and/or other signs) were observed in any of the animals. Thus, two weeks after the patch removal the study was terminated.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) were as follows:

- erythema: 1.00, 2.00, 1.67

- edema: 0, 0.33, 0.33

The total mean scores over all animals (considering readings at 24, 48 and 72 hours after patch removal) were as follows:

- erythema: 1.56

- edema: 0.22

During the study the control areas of all animals were symptom-free. During the study the general state and behaviour of all animals were normal. There were no notable body weight changes during the contact and observation period.

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
For read-across justification please refer to IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
9143/M
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
9135/M
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
9139/M
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
9143/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
9135/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
9139/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
For read-across justification please refer to IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
9138/M
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 2 weeks
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
9132/M
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 2 weeks
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
9145/M
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 2 weeks
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.56
Max. score:
4
Reversibility:
fully reversible within: 2 weeks
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
9138/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 2 weeks
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
9132/M
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 2 weeks
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
9145/M
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 2 weeks
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 2 weeks
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
from 2007-10-03 to 2007-12-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
2004/73/EC
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
August 1998
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: TETRABBIT Kft. 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: Young adult rabbits, 10 weeks old
- Weight at study initiation: 3126 - 3240 g
- Housing: Animals were housed individually in metal cages
- Diet: The animals received PURINA Base – Lap gr. diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum
- Water: The animals received tap water from self-service water system ad libitum
- Acclimation period: 16 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes: 8 - 12 air exchange/hour by central air-condition system
- Photoperiod: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g

VEHICLE
- None
Duration of treatment / exposure:
1 h
Observation period (in vivo):
1, 24, 48, 72 hr, one week
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Not applied

SCORING SYSTEM: Draize 1959

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
9103/M
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
9111/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
9175/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
9103/M
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
9111/M
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
9175/M
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
9103/M
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
9111/M
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
9175/M
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
24/48/72 h
Score:
1.31
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
9103/M
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
9111/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
9175/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: discharge
Basis:
animal #1
Remarks:
9103/M
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: discharge
Basis:
animal #2
Remarks:
9111/M
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
other: discharge
Basis:
animal #3
Remarks:
9175/M
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
other: discharge
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
3
Reversibility:
fully reversible within: 7 days
Interpretation of results:
GHS criteria not met
Conclusions:
The test item Reaction products of IPDA with bisphenol A diglycidylether (BADGE), applied to the rabbits' eye mucosa, caused slight to severe conjunctival irritant effects and in one case slight corneal alteration, which were fully reversible within one week.
Executive summary:

The acute eye irritation study of the test item Reaction products of IPDA with bisphenol A diglycidylether (BADGE) was performed in three albino New Zealand White rabbits. The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 405, 2002). The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. The treated eyes of the test animals were not washed out following the instillation of 0.1 g of the test item, administered in pure state, in single dose. The eyes were examined at 1, 24, 48, 72 hours and one week after application.

One hour after the application of Reaction products of IPDA with bisphenol A diglycidylether (BADGE) into the eyes of rabbits moderate conjunctival redness, slight to moderate chemosis and moderate to severely increased discharge excretion. In one animal diffuse areas of opacity were observed on whole surface of cornea. Iris alterations were not recorded throughout the study.

72 hours after the application in two cases slight redness was found. In above mentioned animal the degree and extension of opacity density did not change to the previous observations. One animal became symptom-free at this time. One week after treatment the study was terminated, as all animals were free of symptoms of irritation.

The general state and the behaviour of animals were normal throughout the study period. There were no notable body weight changes during the contact and observation period.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:

- cornea opacity: 1.00, 0.00, 0.00

-iris: 0.00, 0.00, 0.00

-conjunctival redness: 1.67, 1.00, 1.33

-conjunctival chemosis: 1.00, 0.00, 0.00

-conjunctival discharge: 0.67, 0.00, 0.00

Conclusions:

The test item Reaction products of IPDA with bisphenol A diglycidylether (BADGE), applied to the rabbits' eye mucosa, caused slight to severe conjunctival irritant effects and in one case slight corneal alteration, which were fully reversible within one week. No classification and labelling for eye irritation is necessary according to the criteria of Regulation (EC) No 1272/2008.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
from 2007-09-20 to 2007-12-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
2004/73/EEC
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
August 1998
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: TETRABBIT Kft. 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: Young adult rabbits, 10 weeks old
- Weight at study initiation: 2880 - 2977 g
- Housing: Animals were housed individually in metal cages.
- Diet: The animals received PURINA Base – Lap gr. diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum.
- Water: The animals received tap water from self-service water system ad libitum.
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes: 8 - 12 air exchange/hour by central air-condition system
- Photoperiod: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g

VEHICLE
- None
Duration of treatment / exposure:
1 hr
Observation period (in vivo):
1, 24, 48, 72 hr; 1 week
Number of animals or in vitro replicates:
3 male
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Not performed

SCORING SYSTEM: Draize 1959

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
9174/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
9129/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
9130/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
9174/M
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
9129/M
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
9130/M
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
9174/M
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 1 week
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
9129/M
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 1 week
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
9130/M
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 1 week
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.45
Max. score:
3
Reversibility:
fully reversible within: 1 week
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
9174/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
9129/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
9130/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
other: discharge
Basis:
animal #1
Remarks:
9174/M
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
other: discharge
Basis:
animal #2
Remarks:
9129/M
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
other: discharge
Basis:
animal #3
Remarks:
9139/M
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
other: discharge
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Interpretation of results:
GHS criteria not met
Conclusions:
Reaction products of MXDA with bisphenol A diglycidylether (BADGE) was tested for irritation properties in the rabbit eye. The test item caused moderate conjunctival irritant effects, which were fully reversible within one week. No classification and labelling for eye irritation is necessary according to Regulation (EC) No 1272/2008.
Executive summary:

The acute eye irritation study of the test item Reaction products of MXDA with bisphenol A diglycidylether (BADGE) was performed in three albino New Zealand White rabbits. The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 405, 2002).

The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. The treated eyes of the test animals were not washed out following the instillation of 0.1 g of the test item, administered in pure state, in single dose. The eyes were examined at 1, 24, 48, 72 hours and one week after application.

One hour after the application of Reaction products of MXDA with bisphenol A diglycidylether (BADGE) into the eyes of rabbits moderate conjunctival redness was found.

Conjunctival chemosis, any amount different from normal discharge, cornea and iris alterations were not recorded throughout the study.

24 hours after treatment the irritation symptoms did not change compared to the previous observation.

48 hours after treatment in two animals the irritation symptoms did not change compared to the previous observation. In one animal, slight conjunctival redness was found.

72 hours after the application in two cases slight redness was found. One animal became symptom-free at this time.

One week after treatment the study was terminated, as all animals were free of symptoms of irritation.

The general state and the behaviour of animals were normal throughout the study period. There were no notable body weight changes during the contact and observation period.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:

-cornea opacity: 0.00, 0.00, 0.00

-iris: 0.00, 0.00, 0.00

-conjunctival redness: 1.00, 1.67, 1.67

-conjunctival chemosis: 0.00, 0.00, 0.00

-conjunctival discharge: 0.00, 0.00, 0.00

Conclusions:

The test item Reaction products of MXDA with bisphenol A diglycidylether (BADGE), applied to the rabbits' eye mucosa, caused moderate conjunctival irritant effects, which were fully reversible within one week. No classification and labelling for eye irritation is necessary according to Regulation (EC) No 1272/2008.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
For read-across justification please refer to IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
9103/M
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
9111/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
9175/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
9103/M
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
9111/M
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
9175/M
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
9103/M
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
9111/M
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
9175/M
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.31
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
9103/M
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
9111/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
9175/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: discharge
Basis:
animal #1
Remarks:
9103/M
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: discharge
Basis:
animal #2
Remarks:
9111/M
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
other: discharge
Basis:
animal #3
Remarks:
9175/M
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
other: discharge
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
3
Reversibility:
fully reversible within: 7 days
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
For read-across justification please refer to IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
9174/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
9129/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
9130/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
9174/M
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
9129/M
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
9130/M
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
9174/M
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 1 week
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
9129/M
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 1 week
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
9130/M
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 1 week
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.45
Max. score:
3
Reversibility:
fully reversible within: 1 week
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
9174/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
9129/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
9130/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
other: discharge
Basis:
animal #1
Remarks:
9174/M
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
other: discharge
Basis:
animal #2
Remarks:
9129/M
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
other: discharge
Basis:
animal #3
Remarks:
9139/M
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
other: discharge
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin and eye irritation properties of asymmetrical epoxy amine adduct Reaction Product of Bisphenol A diglycidylether (BADGE) with IPDA and MXDA was assessed using a read across approach from data on symmetrical epoxy amine adducts Reaction products of IPDA with bisphenol A diglycidylether (BADGE) and Reaction products of MXDA with bisphenol A diglycidylether (BADGE), as these substances were considered to show similar toxicological properties.

Skin irritation

IPDA

In a skin irritation study albino New Zealand White rabbits were treated with Reaction products of IPDA with bisphenol A diglycidylether (BADGE). The test item was applied to the intact skin of rabbits as a single dose of 0.5 g. The irritation symptoms were examined at 1, 24, 48 and 72 hours, then one week after the patch removal.

One hour after the patch removal in two animals very slight erythema (scores 1-1) and in one animal well defined erythema (score 2) was observed on the treated skin surfaces. There was no oedema observed during the study.

24 hours after the patch removal the degree of erythema did not change compared to the previous observation.

48 hours after the patch removal very slight erythema (scores 1-1-1) was found in all animals.

72 hours after the patch removal the irritation symptoms did not change compared to the previous observation.

1 week after the patch removal, no irritation symptoms (erythema, oedema and/or other signs) were observed in any of the animals. Thus, one week after the treatment the study was terminated.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) were as follows:

- erythema: 1.00, 1.00, 1.33

- edema: 0, 0, 0

During the study the control areas of all animals were symptom-free. During the study the general state and behaviour of all animals were normal. There were no notable body weight changes during the contact and observation period. Reaction products of IPDA with bisphenol A diglycidylether (BADGE) was tested for skin irritation in rabbits. The observed symptoms were evaluated as fully reversible alterations. No classification and labelling is necessary according to the criteria of Regulation (EC) No 1272/2008.

MXDA

In a skin irritation study albino New Zealand White rabbits were treated with Reaction products of MXDA with bisphenol A diglycidylether (BADGE). The test item was applied to the intact skin of rabbits as a single dose of 0.5 g. The irritation symptoms were examined at 1, 24, 48 and 72 hours, then one and two weeks after the patch removal.

One hour after the patch removal no irritation symptoms (erythema, oedema and/or other signs) were observed in any of the animals.

24 hours after the patch removal in two animals (No.: 9138, 9145) very slight erythema (scores 1-1) and in one animal well defined erythema (score 2) was observed on the treated skin surfaces. In two animals very slight oedema (scores 1-1) appeared at this time.

48 hours after the patch removal no oedema was found on the treated skin surfaces of animals. In two animals well defined (scores 2-2) in one case very slight erythema (score 1) was found.

72 hours after the patch removal the irritation symptoms did not change compared to the previous observation.

1 week after the patch removal, very slight erythema (scores 1-1-1) was found in all animals.

2 weeks after the patch removal, no irritation symptoms (erythema, edema and/or other signs) were observed in any of the animals. Thus, two weeks after the patch removal the study was terminated.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) were as follows:

- erythema: 1.00, 2.00, 1.67

- edema: 0, 0.33, 0.33

The total mean scores over all animals (considering readings at 24, 48 and 72 hours after patch removal) were as follows:

- erythema: 1.56

- edema: 0.22

During the study the control areas of all animals were symptom-free. During the study the general state and behaviour of all animals were normal. There were no notable body weight changes during the contact and observation period. Reaction products of MXDA with bisphenol A diglycidylether (BADGE) was tested for skin irritation in rabbits. Very slight to well defined erythema and very slight oedema could be detected. The observed symptoms were evaluated as fully reversible alterations. No classification and labelling for skin irritation is necessary according to Regulation (EC) No 1272/2008.

Eye irritation

IPDA

An acute eye irritation study of the test item Reaction products of IPDA with bisphenol A diglycidylether (BADGE) was performed in three albino New Zealand White rabbits. The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 405, 2002). The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. The treated eyes of the test animals were not washed out following the instillation of 0.1 g of the test item, administered in pure state, in single dose. The eyes were examined at 1, 24, 48, 72 hours and one week after application.

One hour after the application of Reaction products of IPDA with bisphenol A diglycidylether (BADGE) into the eyes of rabbits moderate conjunctival redness, slight to moderate chemosis and moderate to severely increased discharge excretion. In one animal diffuse areas of opacity were observed on whole surface of cornea. Iris alterations were not recorded throughout the study. 72 hours after the application in two cases slight redness was found. In above mentioned animal the degree and extension of opacity density did not change to the previous observations. One animal became symptom-free at this time. One week after treatment the study was terminated, as all animals were free of symptoms of irritation. The general state and the behaviour of animals were normal throughout the study period. There were no notable body weight changes during the contact and observation period.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:

-cornea opacity: 1.00, 0.00, 0.00

-iris: 0.00, 0.00, 0.00

-conjunctival redness: 1.67, 1.00, 1.33

-conjunctival chemosis: 1.00, 0.00, 0.00

-conjunctival discharge: 0.67, 0.00, 0.00

The test item Reaction products of IPDA with bisphenol A diglycidylether (BADGE), applied to the rabbits' eye mucosa, caused slight to severe conjunctival irritant effects and in one case slight corneal alteration, which were fully reversible within one week. No classification and labelling for eye irritation is necessary according to the criteria of Regulation (EC) No 1272/2008.

MXDA

The acute eye irritation study of the test item Reaction products of MXDA with bisphenol A diglycidylether (BADGE) was performed in three albino New Zealand White rabbits. The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 405, 2002).

The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. The treated eyes of the test animals were not washed out following the instillation of 0.1 g of the test item, administered in pure state, in single dose. The eyes were examined at 1, 24, 48, 72 hours and one week after application. One hour after the application of Reaction Product of Bisphenol A (BADGE) with MXDA into the eyes of rabbits moderate conjunctival redness was found.

Conjunctival chemosis, any amount different from normal discharge, cornea and iris alterations were not recorded throughout the study. 24 hours after treatment the irritation symptoms did not change compared to the previous observation. 48 hours after treatment in two animals the irritation symptoms did not change compared to the previous observation. In one animal, slight conjunctival redness was found. 72 hours after the application in two cases slight redness was found. One animal became symptom-free at this time. One week after treatment the study was terminated, as all animals were free of symptoms of irritation. The general state and the behaviour of animals were normal throughout the study period. There were no notable body weight changes during the contact and observation period.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:

-cornea opacity: 0.00, 0.00, 0.00

-iris: 0.00, 0.00, 0.00

-conjunctival redness: 1.00, 1.67, 1.67

-conjunctival chemosis: 0.00, 0.00, 0.00

-conjunctival discharge: 0.00, 0.00, 0.00

The test item Reaction products of MXDA with bisphenol A diglycidylether (BADGE), applied to the rabbits' eye mucosa, caused moderate conjunctival irritant effects, which were fully reversible within one week. No classification and labelling for eye irritation is necessary according to Regulation (EC) No 1272/2008.

General conclusion

Based on results obtained from the studies performed with both read across substances, Reaction Product of Bisphenol A diglycidylether (BADGE) with IPDA and MXDA is considered not irritating to skin and not irritating to eyes.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes. As a result the substance is not considered to be classified for skin and eye irritation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EC) No 2017/776.