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Toxicological information

Eye irritation

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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:
2013
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

Constituent 1
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

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.