Registration Dossier
Registration Dossier
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EC number: 245-740-7 | CAS number: 23564-05-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 July 1986 - 13 November 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Thiophanate-methyl
- EC Number:
- 245-740-7
- EC Name:
- Thiophanate-methyl
- Cas Number:
- 23564-05-8
- Molecular formula:
- C12H14N4O4S2
- IUPAC Name:
- methyl N-{[2-({[(methoxycarbonyl)amino]methanethioyl}amino)phenyl]carbamothioyl}carbamate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Sizuoka Laboratory Animal Center (Sizuoka)
- Age at study initiation: about 3 months
- Weight at study initiation: 2.91 ± 0.19 kg (at dosing)
- Housing: individually housed in a steel mesh cages (33 x 48 x 35 cm)
- Diet: Standardized pellets of dry diet, RC-4 (Oriental Yeast Co., Ltd., Tokyo), ad libitum
- Water: tap water, ad libitum
- Acclimation period: quarantined for a week prior to use
ENVIRONMENTAL CONDITIONS
- Temperature (°C):19 - 25 (mean temperature: 20.7)
- Humidity (%): 40 - 80 (mean humidity at 9 am: 68.3)
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- 6 animals: eyes were not washed out
3 animals: eyes washed with water 2 minutes after treatment - Observation period (in vivo):
- Readings of ocular lesions were made at 1 hour, 24 hours, 48 hours and 72 hours after the treatment.
- Number of animals or in vitro replicates:
- 3 animals (eyes washed with water) and 6 animals (eyes not washed out)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: 6 animals: no washing; 3 animals: washing with water
- Time after start of exposure: 2 minutes
SCORING SYSTEM: in accordance with scoring system according to OECD 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1-#6 (unwashed)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1 - #3 (washed)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1 - #6 (unwashed)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: #1 - #3 (washed)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 - #6 (unwashed)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 - #3 (washed)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 - #6 (unwashed)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 - #3 (washed)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was determined not to be irritating to the eye.
- Executive summary:
In this assessment of the primary irritation to the eye, 0.1 g of the test item was applied to each left eye of 9 rabbits. The treated eyes of 3 rabbits were washed by water and those of 6 rabbits were not washed. The readings of ocular lesions were made at 1 hour, 24 hours, 48 hours and 72 hours after the application of the test item in comparison with the untreated right eyes. Very mild changes were observed in treated eyes of all animals whose eyes have been washed out and in 4 animals whose eyes have not been washed out. No irritation to the eyes was observed after 24, 48 or 72 hours. Therefore, the test item was determined not to be irritating to the eye.
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