Registration Dossier
Registration Dossier
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EC number: 266-113-4 | CAS number: 66071-94-1 Substance obtained by the partial removal of water from the liquid resulting from steeping corn in a water and sulphur dioxide solution which is allowed to ferment by the action of naturally occurring lactic acid-producing microorganisms.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study in compliance with guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Corn, steep liquor
- EC Number:
- 266-113-4
- EC Name:
- Corn, steep liquor
- Cas Number:
- 66071-94-1
- Molecular formula:
- not applicable: UVCB substance
- IUPAC Name:
- Corn, steep liquor
- Details on test material:
- Name: Corn Steep Liquor
Batch No: E 108 C
UVCB substance
Purity: 100%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- instillation into the conjunctival sac of the left eye on day 1 (the right eye is used as control)
- Observation period (in vivo):
- Any conjunctival, iris and corneal lesion was evaluated approximately one hour, 24 hours, 48 hours and 72 hours after instillation of Corn Steep Liquor.
Mean indices were calculated from results obtained for each rabbit at times 24, 48 and 72 hours. - Number of animals or in vitro replicates:
- 3 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- other: redness score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- other: redness score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- other: redness score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Other effects:
- The application of the test item did not induce colouration of the application site and did not interfere with grading of any eye lesion.
Any other information on results incl. tables
One hour after instillation, all animals had lacrimation (score 3), chemosis (score 3 or 4) and redness (score 2 or 3).
24 hours after instillation, all animals had still lacrimation (score 3), chemosis (score 2) and redness (score 3).
From time 48 hours, ocular lesions decrease because all animals had lacrimation (score 1 or 2), redness (score 1 or 2) and only one animal had chemosis (score 1).
No ocular lesion was persisted on day 8.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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