Registration Dossier
Registration Dossier
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EC number: 932-124-4 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 February-28 February, 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Calcium dihydroxide precipitated with carbon dioxide during sugar juice purification
- EC Number:
- 932-124-4
- IUPAC Name:
- Calcium dihydroxide precipitated with carbon dioxide during sugar juice purification
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Sugar Factory Lime (Wet)
- Analytical purity: 100 % (UVCB)
- Composition of test material, percentage of components: 31% water
- Lot/batch No.: SFL-OC-2013-W1
- Expiration date of the lot/batch: 31 December 2013
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature 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 Laboratories UK Ltd., Leicestershire, UK.
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.12 and 2.58 kg
- Housing: individually housed in suspended cages
- Diet: 2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK
- Water: ad libitum mains drinking water
- Acclimation period: 5 days minimum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 15/h minimum
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 11/02/2013 - 28/02/2013
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye of each animal used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL (97 mg) - Duration of treatment / exposure:
- Animals were exposed to the test material for up to 72 hours.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours following treatment
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not applicable
- Time after start of exposure: Not applicable
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 & 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: Mean of 24, 48 & 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 & 72 hrs
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: Mean of 24, 48 & 72 hrs
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 & 72 hrs
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: Mean of 24, 48 &72 hrs
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 & 72 grs
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: Mean of 24, 48 & 72 hrs
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Other effects:
- Both animals showed expected gain in body weight during the study.
Any other information on results incl. tables
Individual Scores and Individual Total Scores for Ocular Irritation
Rabbit Number and Sex |
72960 Male |
73002 Male |
||||||
IPR = 1 |
IPR = 1 |
|||||||
Time after treatment |
1 h |
24 h |
48 h |
72 h |
1 h |
24 h |
48 h |
72 h |
CORNEA |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
E = Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F = Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
|
|
|
|
|
|
|
|
D |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (D x 5) |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
CONJUNCTIVAE |
|
|
|
|
|
|
|
|
A = Redness |
2 |
2 |
1 |
0 |
2 |
1 |
0 |
0 |
B = Chemosis |
2 |
1 |
0 |
0 |
1 |
1 |
0 |
0 |
C = Discharge |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Score (A + B + C) x 2 |
10 |
6 |
2 |
0 |
8 |
4 |
0 |
0 |
Total Score |
1 |
6 |
2 |
0 |
8 |
4 |
0 |
0 |
IPR = Initial pain reaction; Class 1 – Reaction by animal = A few blinks only, normal within one or two Minutes; Descriptive reading = Practically no initial pain
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- SFL is not irritating to the eyes of rabbits.
- Executive summary:
The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit. A single application of the test item to the non-irrigated eye of two rabbits produced iridial inflammation and moderate conjunctival irritation. One treated eye appeared normal at the 48-Hour observation and the other treated eye appeared normal at the 72-Hour observation. The test item produced a maximum group mean score of 11.5 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labeling and Packaging of Substances and Mixtures.
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