Registration Dossier
Registration Dossier
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EC number: 217-385-8 | CAS number: 1830-54-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dimethyl 3-oxoglutarate
- EC Number:
- 217-385-8
- EC Name:
- Dimethyl 3-oxoglutarate
- Cas Number:
- 1830-54-2
- Molecular formula:
- C7H10O5
- IUPAC Name:
- dimethyl 3-oxoglutarate
- Details on test material:
- Name of test material (as cited in study report): LZ409
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance):
- Substance type: organic
- Physical state: light yellow liquid
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Other: stored in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited, Shaw's Farm
- Age at study initiation:
- Weight at study initiation: 2.39-2.50 kg
- Housing: The animals were housed individually in stainless steal cages with a Noryl muolded dual level interior and perforated floor beneath which was an absorbent paper lined tray.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h/12h
IN-LIFE DATES: From: To:
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Observation period (in vivo):
- 1 h, 24 h, 48h, 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand held magnifier and pen torch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 1, 24, 48
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: Discharge
- Irritant / corrosive response data:
- Test Eye: Conjuctival redness(some blood vessels definitely hyperaemic) was noted up to 48 h after instillation of the test item in 2 animals. Slight conjuctival discharge was noted in only pne anilam 1 h after instillation.
Control Eye: No responses were noted in any control eye. - Other effects:
- No additional observations noted during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not classified as eye irritant according to EU regulations.
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