Registration Dossier
Registration Dossier
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EC number: 605-268-8 | CAS number: 161797-99-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24/05/2011-21/06/2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- ethyl 2-(4-hydroxyphenyl)-4-methyl-1,3-thiazole-5-carboxylate
- EC Number:
- 605-268-8
- Cas Number:
- 161797-99-5
- Molecular formula:
- C13H14ClNO3S
- IUPAC Name:
- ethyl 2-(4-hydroxyphenyl)-4-methyl-1,3-thiazole-5-carboxylate
- Test material form:
- solid: crystalline
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labes Co., Ltd
- Age at study initiation: 12 weeks
- Weight at study initiation: 2.22-2.38 kg
- Housing: in an animal room
- Diet (e.g. ad libitum): a commercial pellet diet, RC4 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 20%
- Air changes (per hr): 8 times or more/ hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- water
- Amount / concentration applied:
- Twenty five milligrams of the test substance equivalent to 0.1 mL were dropped into the right conjunctival sac of rabbit.
- Observation period (in vivo):
- Eye reactions were observed at 1, 24, 48 and 72 hours after application. As the observed eye reaction did not disappear within this period, the eyes were observed also at 7 days after application to confirm the progress of recovery.
- Number of animals or in vitro replicates:
- 3 female rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
In the initial test, both conjunctival redness and chemosis graded at 1 were observed at 1 hour after application, and conjunctival redness graded at 1 alone was observed at 24 hours after application. The eye reaction disappeared by the observation at 48 hours after application. Since corrosive and severe irritative reactions were not observed as a result of
the initial test, a confirmatory test was executed.
In the confirmatory test, both conjunctival redness and chemosis graded at 1 were observed in 2 animals at 1 hour after application.
One (Animal ID No. 4) of the eye reactions disappeared by the observation at 48 hours after application and the other one (Animal ID No. 3) disappeared at 7 days after application.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A potential eye irritation/corrosion of Manufacturing Intermediate of TMX-67 (Thiazole Derivative (Free Base Form)) to rabbit eye was not classified into any of
categories based on the criteria of GHS under the conditions of this study.
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