Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
8.2.-15.2.2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was carried out in accordance with internationally valid GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
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
Details on test material:
- Name of test material (as cited in study report): 3,4-Ethylenedioxythiophene
- Comercial name. EDOT
- Substance type: pure organic substance
- Physical state: liquid near colourless to pale yellow
- Analytical purity: > 99%
- Lot/batch No.: 091201
- Expiration date of the lot/batch: 21.1.2011
- Storage condition of test material: Keep in dark at room temperature. Stored in amber glass bottles under the argon atmosphere. Minimalize time for handling with substance without protective argon atmosphere as possible. Maximal time without protective atmosphere is 30 min.
- pH: approximately 4 (by contact of application form with universal indicator pH strip moistened with water, strip producer Lach-Ner, s.r.o. (Neratovice)

Test animals / tissue source

Species:
rat
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic, RČH CZ 21760152
- Age at study initiation: 4-5 moths
- Weight at study initiation: 3.5-3.7 kg
- Housing: Conventional animal room – individually in metallic cages
- Diet (e.g. ad libitum): Standard pelleted diet TM-MAK 1 for rabbits and guinea pigs ad libitum (producer: Ing.Mrkvička Miroslav - Výroba krmných směsí, Mlýn Kocanda, 252 42 Jesenice u Prahy)
- Water (e.g. ad libitum): Drinking tap water ad libitum (quality corresponding to the Regulation No.: 252/2004 Czech Coll. of Law)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C, permanently monitored
- Humidity (%): 30 – 70%, permanently monitored
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark


STUDY TIME SCHEDULE
Animal supply: 27. 01. 2010
Experimental part of study: 08. 02. – 15. 02. 2010

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3 (2 males and 1 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM:
- According to the grading system given in Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

TOOL USED TO ASSESS SCORE: After recording the observations at 24 hours, the eyes of rabbit were further examined with the aid of fluorescein and the ophthalmoscopy.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0 - 1
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 73 hrs
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The following changes were observed on eye at 1 hour after application: conjunctivae – diffuse, crimson colour, individual vessels not easily discernible or diffuse beefy red and chemosis – some swelling above normal in all rabbits. Conjunctivae – some blood vessels hyperaemic (injected) was observed in all rabbits at the 24 hours after application. At 48 and 72 hours after application no signs of eye irritation were observed.
No clinical signs of systemic intoxication were detected.


Examination of eye irritation after single application demonstrated, that the test substance, 3,4-Ethylenedioxythiophene, is not irritating for eye of rabbit.

Executive summary:

The test substance, 3,4-Ethylenedioxythiophene, was tested for the assessment of eye irritation/corrosion effects using albino rabbit (New Zealand Albino breed).

The test was performed according to the Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

The test was performed initially using one animal. Because a corrosive effect was not observed in initial test, the response was confirmed using two additional animals.

The following changes were observed on eye at 1 hour after application: conjunctivae – diffuse, crimson colour, individual vessels not easily discernible; chemosis – some swelling above normal in two rabbits (No.13 and No.14) and conjunctivae – diffuse beefy red; chemosis – some swelling above normal was observed in one rabbits (No.15). Conjunctivae – some blood vessels hyperaemic (injected) was observed in all rabbits at the 24 hours after application. At 48 and 72 hours after application no signs of eye irritation were observed.

No clinical signs of systemic intoxication were detected.

Examination of eye irritation after single application demonstrated, that the test substance, 3,4-Ethylenedioxythiophene, is not irritating for eye of rabbit.