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Toxicological information

Skin irritation / corrosion

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Administrative data

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

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
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)

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with 3-aminomethyl-3,5,5-trimethylcyclohexylamine
EC Number:
500-101-4
EC Name:
4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with 3-aminomethyl-3,5,5-trimethylcyclohexylamine
Cas Number:
38294-64-3
Molecular formula:
C41H68N4O4
IUPAC Name:
Reaction product of 3-aminomethyl-3,5,5-trimethylcyclohexanamine with oligomerisation products of 4,4'-propane-2,2-diyldiphenol with 2-(chloromethyl)oxirane
Details on test material:
NA

Test animals

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.

Test system

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)

Results and discussion

In vivo

Resultsopen allclose all
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.

Applicant's summary and conclusion

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.