Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Not reported
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Incomplete reporting on materials and methods with an insufficient level of detail on results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
30D11
Appearance: clear, colourless liquid with a pungent odour.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 2.0 - 3.1 kg
- Diet (e.g. ad libitum): Purina Rabbit Chow available ad libitum.
- Water (e.g. ad libitum): Water available ad libitum.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL.
Duration of treatment / exposure:
A single treatment.
Observation period (in vivo):
14 days.
Number of animals or in vitro replicates:
9
Details on study design:
The eyes were judged free of irritation and corneal damage (confirmed by sodium fluorescein examination) prior to initiation of study.
Administration: A single application of 0.1 mL was made into the conjunctival sac of the left eye of nine rabbits. Three eyes were irrigated with 20 mL of tap water two seconds after application, three eyes were irrigated four seconds after application, and three eyes were not irrigated but were held closed for one second. Untreated right eyes served as controls.

Observations and Records:

Gross Signs of Eye Irritation and Systemic Toxicity - Observations recorded at 24, 48, and 72 hours and 4, 7, 10, and 14 days following application. Eye irritation graded and scored according to the numerical scoring system of Draize (see below).
Body Weights - Recorded initially and terminally.
Terminal Fluorescein Examination: On Day 7, Day 10, or Day 14, treated eyes were examined with 2.0% sodium fluorescein stain for evidence of corneal damage.

SCORING SYSTEM: Draize Scale for Ocular Irritation.

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 orcombination 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


Results and discussion

In vivo

Irritant / corrosive response data:
The test material was severely irritating to the eye. The response was not significantly altered by washing.
Other effects:
Principal Toxic Effects - One animal with the eye irrigated after two seconds died by day 4. Blinking and preening were noted immediately following instillation of the test material in several animals, and moderate weight loss was observed in four animals.

Gross Signs of Eye Irritation -
- From 24 hours through day 14, irritation included blanched conjunctivae, marked conjunctival erythema in one irrigated eye, slight to marked chemosis and discharge, slight to moderate iritis, and slight to marked corneal opacity. In two eyes irrigated after two seconds, corneal vascularization was noted on day 7, day 10, and day 14. Four irrigated eyes and the three non-irrigated eyes could not be completely graded by day 10 or day 14 due to extreme irritation and destruction of the eye.
-Terminal Fluorescein Examination - On day 14, the examination revealed evidence of corneal damage in two eyes irrigated after two seconds, in two eyes irrigated after four seconds, and in the three non-irrigated eyes. The remaining two irrigated eyes were not stained due to death or complete destruction of eye.

Any other information on results incl. tables

No further information on results is available.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test material was severely irritating to the eye and caused irreversible damage. Eye response was not significantly altered by washing and generally included blanched conjunctivae, slight to marked chemosis and discharge, slight to moderate irititis, slight to marked corneal opacity and, in four animals, complete destruction of the eye.
Executive summary:

The test material was severely irritating to the eye and caused irreversible damage. Eye response was not significantly altered by washing and generally included blanched conjunctivae, slight to marked chemosis and discharge, slight to moderate irititis, slight to marked corneal opacity and, in four animals, complete destruction of the eye.