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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:
From 12 June 2012 to 07 July 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

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 to 20 weeks old
- Weight at study initiation: 2.49 to 2.97 kg
- Housing: individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70 %
- Air changes (per hr): 15 changes /h
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL of the undiluted test item, which was found to weigh approximately 62 mg
Duration of treatment / exposure:
Aftre instillation, the upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test item, and then released.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three male animals
Details on study design:
SCORING SYSTEM: Draize Scale for Scoring Ocular Irritation

1. CONJUNCTIVAE
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3

(B) Chemosis
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids half closed to completely closed 4

(C) Discharge
No discharge 0
Any amount different from normal (does not include small
amounts observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs a
considerable area around the eye 3
THE TOTAL SCORE = (A + B + C) x 2 MAXIMUM TOTAL = 20


2. IRIS
(D) Values
Normal 0
Folds above normal, congestion, swelling, circumcorneal injection
(any or all of these or combination of any thereof) iris still reacting
to light (sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2
THE TOTAL SCORE = D x 5 MAXIMUM TOTAL = 10

3. CORNEA
(E) Degree of Opacity (most dense area used)
No opacity 0
Scattered or diffuse areas, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque, iris not discernible through the opacity 4

(F) Area of Cornea Involved
One quarter (or less) but not zero 1
Greater than one quarter but less than half 2
Greater than half but less than three quarters 3
Greater than three quarters, up to whole area 4
THE TOTAL SCORE = (E x F) x 5 MAXIMUM TOTAL = 80

MAXIMUM TOTAL SCORE POSSIBLE = 110


The 24h examination was performed under ultra-violet light following treatment with Sodium Fluorescein BP

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all three animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
all three animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: all three animals
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
other: all three animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Slight redness of the conjunctivae was noted in all animals at the 1h- and 24h- reading.
Slight chemosis was also noted in all animals at the 1h-reading in all animals and slight discharge was noted at the same observation period in two animals.
All reactions were fully reversible and the animals were clean after 48 hours.

Any other information on results incl. tables

The body weight of the animals were within the range for animals of this strain and age.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not considered to be irritant for eye according the GHS criteria.
Executive summary:

An in vivo eye irritation study was conducted with three male adult New Zealand rabbits according to OECD guideline 405.

0.1 mL of the test substance was instilled in the left eye of each animal and the animals were scored approximately 1, 24, 48 and 72 hours after instillation.

After single application of the test item to the non-irrigated eye of the three rabbits only minimal conjunctival irritation was noted. This included conjunctival redness, chemosis and discharge. All treated eyes appeared normal at the 48-Hour observation.

The test item is not considered to be irritant for the eyes according to GHS criteria.