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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restricitons.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: lack of details on test substance
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: lack of details on test substance
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Optimet TM RG
IUPAC Name:
Optimet TM RG
Details on test material:
- Name of test material (as cited in study report): Optimet TM RG
- Physical state: solid
- Analytical purity: not reported
- Lot/batch No.: 10GUS013

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated right eye served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
Until the observation period of 22 days (Exception: A trace of test item was seen for two animals one hour after introduction into the conjunctival sac and in order to allow satisfactory conditions for grading, the treated eye was rinsed)
Observation period (in vivo):
Any conjunctival, iris and corneal lesion was evaluated approximately one hour, 24 hours, 48 hours, 72 hours and 8 days after instillation for two animals and 15 days and 22 days after instillation of Optimet TM RG for one animal.
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): a trace of test item was seen for two animals one hour after introduction into the conjunctival sac and in order to allow satisfactory conditions for grading, the treated eye was gently rinsed using 10mL of sterile isotonic saline solution. The controlateral eye was similary rinsed and used for control purposes.

SCORING SYSTEM: Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 22 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
2
Max. score:
3
Reversibility:
other: due to a technician error, the animal was euthanased before the observation on day 8
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 24, 48, and 72 hours
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 22 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
3.33
Max. score:
4
Reversibility:
other: due to a technician error, the animal was euthanased before the observation on day 8
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 24, 48, 72 hours
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
One hour after instillation, all animals had severe chemosis (score 2 to 4) with lacrimation (score 2) and redness of the conjunctivae (score 1 to 2).
24, 48 and 72 hours after instillation, chemosis (score 3 to 4) and redness of the conjunctivae (score 2 to 3) persisted in three animals. Lacrimation (score 1 to 2) persisted in two animals 24 hours after, in one animal 48 hours after and recurred in two animals 72 hours after. The fourth animal had a slight chemosis (score 1) and a slight redness of the conjunctivae (score 1) 24 hours after instillation and no ocular lesion persisted at time 48, 72 hours and 8 days after instillation. Iris lesions (score 1) were observed 24 and 48 hours after instillation for one animal.
On D8 and D15, only one of three observed animals had chemosis (score 1 to 2) and redness of the conjunctivae (score 1). No ocular lesion persisted 22 days after instillation.

Any other information on results incl. tables

Table 1: Mean Index:

Treatment

Animal number

Chemosis

Redness

Iris

Cornea

OptimetTMRG

OptimetTMRG

OptimetTMRG

OptimetTMRG

1

2

3

4

4

0.33

3.33

1.67

2.67

0.33

2

1.33

0.67

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information DSD: Xi, R36: irritating to eyes; CLP: Eye Irritant - Category 2 Criteria used for interpretation of results: other: DSD and CLP
Executive summary:

Bouchard, A. (2010)

In a primary irritation study, the eye irritation potential of OptimetTM RG (Batch No.10GUS013) was tested. 0.1 g of the test substance was introduced into the conjunctival sac of the left eye of each of the four animals. The untreated right eye served as a control.

The application of the test item did not induce colouring of the application site and did not interfere with grading of any eye lesion but a trace of test item was seen for two animals one hour after introduction into the conjunctival sac and in order to allow satisfactory conditions for grading, the treated eye was gently rinsed using 10 mL of sterile isotonic saline solution. The controlateral eye was similary rinsed and used for control purposes.

Any conjunctival, iris and corneal lesion was evaluated approximately one hour, 24 hours, 48 hours, 72 hours and 8 days after instillation for two animals and 15 days and 22 days after instillation of OptimetTM RG for one animal.

Mean indices were calculated from results obtained for each rabbit at times 24, 48 and 72 hours.

Results obtained were as follows:

One hour after instillation, all animals had severe chemosis (score 2 to 4) with lacrimation (score 2) and redness of the conjunctivae (score 1 to 2).

24, 48 and 72 hours after instillation, chemosis (score 3 to 4) and redness of the conjunctivae (score 2 to 3) persisted in three animals. Lacrimation (score 1 to 2) persisted in two animals 24 hours after, in one animal 48 hours after and recurred in two animals 72 hours after. The fourth animal had a slight chemosis (score 1) and a slight redness of the conjunctivae (score 1) 24 hours after instillation and no ocular lesion persisted at time 48, 72 hours and 8 days after instillation. Iris lesions (score 1) were observed 24 and 48 hours after instillation for one animal.

On D8 and D15, only one of three observed animals had chemosis (score 1 to 2) and redness of the conjunctivae (score 1). No ocular lesion persisted 22 days after instillation.

 

Under the experimental conditions adopted, OptimetTM RG was found to be irritant for the eye of the rabbit.

Classification according to Directive No.67/548/EC and subsequent amendments and CLP Regulation No.1272/2008:

Symbol: Xi.

Indication of danger: IRRITANT – Category 2.

Risk phrase: R36: irritating to eyes.

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