Registration Dossier
Registration Dossier
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EC number: 614-070-0 | CAS number: 674773-12-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- methyl 5-amino-4-cyano-3-(2-methoxy-2-oxoethyl)thiophene-2-carboxylate
- Cas Number:
- 674773-12-7
- Molecular formula:
- C10H10N2O4S
- IUPAC Name:
- methyl 5-amino-4-cyano-3-(2-methoxy-2-oxoethyl)thiophene-2-carboxylate
- Reference substance name:
- dimethyl 5-amino-4-cyanothiophene-2,3-dicarboxylate
- IUPAC Name:
- dimethyl 5-amino-4-cyanothiophene-2,3-dicarboxylate
- Details on test material:
- - Name of test material (as cited in study report): Thiofaminomet (dimethyl 5-amino-4-cyanothiophene-2,3-dicarboxylate)
- Physical state: greenish yellow powder
- Lot/batch No.: 45
- Expiration date of the lot/batch: 09 2004 (based on the bottle label)
- Storage condition of test material: at room temperature
- Date of analysis: 30 10 2003
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: Breeder: Ferenc Sándor, Address: Vörös Hadsereg 131., H-2173, Kartal, Hungary
- Age at study initiation: 11 weeks
- Weight at study initiation: 2983-3336 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): PURISTAR standard diet for rabbits produced by AGRIBRANDS Europe Hungary, ad libitum
- Water (e.g. ad libitum): tap water for human consumption ad libitum, from automatic self-supplying system
- Acclimation period: 16 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12 hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the contralateral eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of test item Thiofaminomet in pure state, in a single dose - Duration of treatment / exposure:
- The eyes of the test animals were not washed out after the application of the test item
- Observation period (in vivo):
- 72 hours (the eyes were examined at 1, 24, 48, and 72 hours after the treatment)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes of the test animals were not washed out after the application of the test item
SCORING SYSTEM:
- Draize (1959)
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 6
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: slight redness, and moderately increased discharge excretion
- Irritant / corrosive response data:
- One our after treatment some blood vessels hyperaemic occured in every animal. In all cases the discharge with moistening of the lids and hairs just adjacent to lids was found. Chemosis, corneal and iris alterations were not found during the study.
One our after the treatment the obseved highest irritation index was 6.
24 hours after the treatment primary irritation symptoms were not found in the treated animals.
48 and 72 hours after the treatment every animals was symptom-free.
72 hours after the treatment the study was terminated, since no primary irritation symptoms occured. - Other effects:
- The general state and behaviour of animals were normal during the whole study.
Chemosis, corneal, and iris alterations were not found during the study.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion the test item applied to the rabbits's eye mucosa proved to be slightly irritant according to the irritation index.
The observed symptoms can be evaluated as fully reversible alterations.
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