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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:
14. 04. – 22. 04. 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Expiration: 03/2029
Storage condition of test material: at the room temperature in tightly closed container

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
male/female
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 21760118; with Certificate of good health condition
- Age at study initiation: not specified
- Weight at study initiation: 2.0 - 2.1 kg
- Housing: individually in metallic cages
- Diet: ad libitum (standard pelleted diet for rabbits TM-MAK1)
- Water: ad libitum
- Acclimation period: at least 5 days
no signs of diseases were observed at clinical check-in, in acclimatization period and before start of experiment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30 – 70%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 /12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye (on the right side) served as a control.
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
The test substance was placed in the conjunctival sac of one eye of animal after gently pulling the lower lid away from the ball. After application the lids were gently held together for about one second to prevent loss of the test substance.
Observation period (in vivo):
24, 48, 72 hours
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): careful washing with water
- Time after start of exposure: 24 hour

SCORING SYSTEM:
see Any other information ...

TOOL USED TO ASSESS SCORE:
After recording the observations at 72 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:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 20
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 10
Time point:
24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 10
Time point:
48 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 10
Time point:
72 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 11
Time point:
24 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 11
Time point:
48 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 11
Time point:
72 h
Score:
0
Max. score:
3

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
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 rabbits No. 16 and 17. Conjunctivae – some blood vessels hyperaemic (injected) and chemosis – some swelling above normal was observed in rabbit No. 18 at 1 hour after application. After rinsing the changes in the eyes have improved rapidly.
No pathological changes of eyes of all rabbits were observed for the rest of the study. During the observation period (24, 48 and 72 hours after application) no irritating effects on the 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, 2-(3´, 5´-Dichloro-2´-hydroxyphenyl)-4-quinazolinone, is not irritating to eye of rabbit.
Executive summary:

The test substance, 2-(3´,5´-Dichloro-2´-hydroxyphenyl)-4-quinazolinone, 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 (No. 16). Because no corrosive or severe irritating effects were observed in initial test, the response was confirmed using two additional animals (No. 17 and No. 18).

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 rabbits No. 16 and 17. Conjunctivae – some blood vessels hyperaemic (injected) and chemosis – some swelling above normal was observed in rabbit No. 18 at 1 hour after application. No pathological changes of eyes of all rabbits were observed for the rest of the study. During the observation period (24, 48 and 72 hours after application) no irritating effects on the 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, 2-(3´, 5´-Dichloro-2´-hydroxyphenyl)-4-quinazolinone, is not irritating to eye of rabbit.