Registration Dossier
Registration Dossier
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EC number: 619-682-1 | CAS number: 224049-04-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 Aug 2005 - 28 Dec 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, 12-Nousan-No.8147, Eye Irritation Study
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,4-dichloro-N-(2-cyanophenyl)-1,2-thiazole-5-carboxamide
- EC Number:
- 619-682-1
- Cas Number:
- 224049-04-1
- Molecular formula:
- C11H5Cl2N3OS
- IUPAC Name:
- 3,4-dichloro-N-(2-cyanophenyl)-1,2-thiazole-5-carboxamide
- Reference substance name:
- 3,4-dichloro-2'-cyano-1,2-thiazole-5-carboxanilide
- IUPAC Name:
- 3,4-dichloro-2'-cyano-1,2-thiazole-5-carboxanilide
Constituent 1
Constituent 2
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. (Ina, Japan)
- Age at study initiation: 16 weeks
- Weight at study initiation: 2.82 - 2.98 kg
- Housing: The animals were caged individually in suspended aluminium cages with stainless steel wire-meshed front and floor (W45 x D55 x H35 cm, Yamato Scientific Co., Ltd., Japan). The cages were placed on racks. Cages were changed once per two weeks with washed and sterilized ones.
- Diet: Approximately 120 g/day of LRC4 (Lot No. 050518, Oriental Yeast Co., Ltd., Japan)
- Water: Filtered tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±2 (actual temperature measured: 21.7 - 22.2 °C)
- Humidity (%): 30 - 70 (actual humidity measured: 51.7 - 71.9%)
- Air changes (per hr): More than 10 per hour
- Photoperiod (hrs dark / hrs light): 12/12 hrs
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye was used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL, equivalent to 0.043 g. - Duration of treatment / exposure:
- 24 hrs
- Observation period (in vivo):
- 72 hrs
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposed eye was washed 24 hrs after exposure started
- Time after start of exposure: 24 hrs
SCORING SYSTEM:
Grading of irritation reactions was performed according to the Draize system. The irritation potential of the substance was classified according to the method of Kay and Calandra (Maximum Mean Total Score, MMTS).
TOOL USED TO ASSESS SCORE:
A hand-slit lamp was used to score corneal opacity, and then fluorescein as an additional aid during the scoring at 24, 48 and 72 hrs.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The test substance caused a mild discharge from the eye of one animal, observed 1 hr after the administration. The reaction was fully reversible within 24 hours. The other two animals did not show any reaction to the exposure to the test substance.
- Other effects:
- No clinical signs of systemic toxicity were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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