Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

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

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 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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

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

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.