Registration Dossier
Registration Dossier
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EC number: 684-879-1 | CAS number: 848641-69-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov - Dec 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-Ethyl-3-methylimidazolium Diethyl Phosphate
- Cas Number:
- 848641-69-0
- Molecular formula:
- C6H11N2 C4H10O4P
- IUPAC Name:
- 1-Ethyl-3-methylimidazolium Diethyl Phosphate
- Test material form:
- liquid
- Details on test material:
- Batch No 187-9-113-Y
Expiry date: 2021-1-30
Constituent 1
- Specific details on test material used for the study:
- Yellow liquid
Batch no.: Batch 1.3
20% water (Correction factor 1.25)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Manfred Bauer Kaninchen, 74632 Neuenstein, Germany
- Age at study initiation: approx. 8.5 months
- Weight at study initiation: 3.8 - 4.8 kg
- Housing: individually in cages with dimensions of 380 mm x 425 mm x 600 mm
- Diet (e.g. ad libitum): ssniff K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 07.11. To: 07.12.2016
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.125 mL
- Concentration (if solution): 80 %
Due to the water content of the test item of 20% a correction factor of 1.25 was used.
VEHICLE
no vehicle utilised - Duration of treatment / exposure:
- No washing of the eye after application of test substance performed
- Observation period (in vivo):
- The eyes were examined ophthalmoscopically with a slit lamp prior to the administra-tion and 1, 24, 48, 72 hours and 7, 14 and 21 days after the administration.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: n.a.
SCORING SYSTEM:
According to Draize scale
TOOL USED TO ASSESS SCORE:
One day before and 24 hours after administration, fluorescein was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions. The fluorescein test was repeated on each day of observation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Conjunctival redness (grade 1) was observed in all animals 1 hour after administration.
The corneae and the irises were not affected by administration of the test item. - Other effects:
- There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to EC Regualtion 1272/2008 the test item is non-irritating to the eye. Classification and labelling are not necessary.
- Executive summary:
The test substance was tested for its eye irritant potential in rabbit eyes according to OEC 405.
Under the present test conditions, a single instillation of 0.125 mL test item into the conjunctival sac of the right eye of 3 rabbits caused the following changes: Conjunctival redness (grade 1) was observed in all animals 1 hour after administration.
The corneae and the irises were not affected by administration of the test item.
There were no systemic intolerance reactions.
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