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EC number: 205-517-7 | CAS number: 141-98-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- O-isopropyl ethylthiocarbamate
- EC Number:
- 205-517-7
- EC Name:
- O-isopropyl ethylthiocarbamate
- Cas Number:
- 141-98-0
- Molecular formula:
- C6H13NOS
- IUPAC Name:
- N-ethyl(propan-2-yloxy)carbothioamide
- Reference substance name:
- Carbamothioic acid, ethyl, O-(1-methyl-ethyl) ester
- IUPAC Name:
- Carbamothioic acid, ethyl, O-(1-methyl-ethyl) ester
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): IPETC
- Physical state: liquid
- Stability under test conditions: stable
- Storage condition of test material: ambient
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG branch Löhndorf, 24601 Löhndorf/Post Wankendorf, Germany
- Age at study initiation: 6.5-7.5 months
- Weight at study initiation: At dosing
Animal no. 1: 2.8 kg
Animal no. 2: 2.5 kg
Animal no. 3: 2.5 kg
At Termination of test
Animal no. 1: 2.8 kg
Animal no. 2: 2.6 kg
Animal no. 3: 2.5 kg
- Housing: Singly in 380mm*425mm*600mm cages
- Diet (e.g. ad libitum): ssniff ® K-H V2333 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: minimum 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark
IN-LIFE DATES: From: July 12, 2012 To: July 21, 2012
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye served as control, right eye as test eye
- Amount / concentration applied:
- 0.1 mL of the test item was administered into one eye each of three animals.
- Duration of treatment / exposure:
- 24 hours after instillation the eyes were rinsed with 20 mL NaCl solution. For 8 hours following test item application, the animals were kept singly in restrain¬ers which allowed free movement of the head but prevented a complete body turn, wiping of the eyes with the paws and excluded irritation of the eye by excre¬ments and urine.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with NaCl solution
- Time after start of exposure: 24
SCORING SYSTEM:
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: (swelling, refers to lids and/or nictitating membrane)
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: (redness, palpebra/bulbar conjunctivae; excl. cornea/iris)
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 Hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- Under the present test conditions, a single instillation of 0.1 mL IPETC per animal into the conjunctival sac of the right eye of three rabbits caused the following changes:
Corneal opacity (grade 1) was observed in animal nos. one and three 24 and 48 hours after instillation.
The fluorescein test performed 24 hours after instillation revealed corneal staining in animal nos. 1 and 3 (up to 1/4 of the surface).
Irritation of the iris (grade 1) was observed in animal no. one 24 hours after instillation.
Conjunctival redness (grade 1) was observed in all animals 60 minutes and in animal nos. 1 and 3 up to 24 hours after instillation.
Chemosis (grade 1) was observed in all animals 60 minutes after instillation.
There were no systemic intolerance reactions.
All symtoms were fully reversible within 72 hours after exposure.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU GHS criteria not met
- Conclusions:
- Under the present test conditions, under the criteria set up in EC-Commission directive 67/548/EEC and EC-Regulation 1272/2008, the test item is concluded to be non-irritating to eyes
- Executive summary:
An in vivo eye irritation/corrosion test with the test substance was performed in 3 rabbits in accordance with OECD Guideline 405. Based on the obtained test results and in accordance with the criteria of Classification, Labelling and Packaging of Substances and Mixtures Regulation (EC) No 1272/2008 (CLP Regulation), the test substance is not classified for eye irritation.
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