Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
2012
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

Constituent 1
Chemical structure
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:
O-isopropyl ethylthiocarbamate
Constituent 2
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

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
- Humidity (%):
- Air changes (per hr):
- 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:
cornea opacity score
Basis:
mean
Time point:
other: 24 hourss after dosing
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 Hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours after dosing
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness, palpebra/bulbar conjunctivae; excl. cornea/iris)
Basis:
mean
Time point:
other: 60 minutes after dosing
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Remarks:
(swelling, refers to lids and/or nictitating membrane)
Basis:
mean
Time point:
other: 60 minutes after dosing
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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