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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28.11.-5.12.2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was carried out in accordance with internationally valid GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

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): Centralit- Substance type: pure substance- Physical state: white crystalline powder- Analytical purity: 99.9% (w/w)- Expiration date of the lot/batch: 16.9.2016- Stability under test conditions: stable- Storage condition of test material: in the dark place at laboratory temperature- pH: approximately 7

Test animals / tissue source

Species:
rabbit
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- Age at study initiation: 2 – 5 months- Weight at study initiation: 3.1 – 3.6 kg- Housing: individually in metallic cages - Diet (e.g. ad libitum): standard pelleted diet TM-MAK 1 for rabbits and guinea pigs- Water (e.g. ad libitum): drinking tap waterENVIRONMENTAL CONDITIONS- Temperature (°C): 20 +/- 3°C- Humidity (%): 30-70%- Air changes (per hr): approximately 15 air changes per hour- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour darkSTUDY TIME SCHEDULEAnimal supply: 16. 11. 2011Experimental part of study: 28. 11. – 05. 12. 2011

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
72 h
Observation period (in vivo):
1, 24, 48, 72 hours
Number of animals or in vitro replicates:
1 male - initial test2 males - confirmatory test
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): noSCORING SYSTEM: according to the grading system given in Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Council Regulation (EC) No.440/2008.TOOL USED TO ASSESS SCORE: After recording the observations at 24 hours, the eyes of rabbit were 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 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria 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 in all rabbits and some swelling above normal in one rabbit. At 24, 48 and 72 hours after application no irritating effects of eye was observed in all animals. No clinical signs of systemic intoxication were detected. Evaluation of results after single application demonstrated that the test substance, Centralit, is not irritating for eye of rabbit.
Executive summary:

The test substance, Centralit, 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 or severe irritating effects were 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 in all rabbits and some swelling above normal in one rabbit (No. 16). At 24, 48 and 72 hours after application no irritating effects of eye was observed in all animals.

No clinical signs of systemic intoxication were detected.

Evaluation of results after single application demonstrated that the test substance, Centralit, is not irritating for eye of rabbit.