Registration Dossier
Registration Dossier
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EC number: 600-418-9 | CAS number: 1033-16-5
Eye irritation
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:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- 2-(3,5-dichloro-2-hydroxyphenyl)-3,4-dihydroquinazolin-4-one
- EC Number:
- 600-418-9
- Cas Number:
- 1033-16-5
- Molecular formula:
- C14H8Cl2N2O2
- IUPAC Name:
- 2-(3,5-dichloro-2-hydroxyphenyl)-3,4-dihydroquinazolin-4-one
- Test material form:
- solid
- Details on test material:
- Expiration: 03/2029
Storage condition of test material: at the room temperature in tightly closed container
Constituent 1
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.
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