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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:
1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no
Remarks:
This study was conducted prior to creation of the REACH regulation. The study was well documented and is sufficient for classification.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test material was stored frozen.

FORM AS APPLIED IN THE TEST (if different from that of starting material): The test material was warmed to approximately 28°C and administrated undiluted.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HRP, Inc.
- Weight at study initiation: 3003 g
- Housing: The animal was individually housed in a screen-bottom cage in temperature- and humidity-controlledquarter
- Diet (e.g. ad libitum): ad libitum; Laboratory Rabbit Diet HF #5326, PMI Feeds, Inc.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days

IN-LIFE DATES: From: 18 March 1994 To: 15 April 1994

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single exposure; the eye remained unwashed
Observation period (in vivo):
1, 24, 48, 72, and 96 hours and days 7, 14, 21, and 28 after treatment
Number of animals or in vitro replicates:
1 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eye remained unwashed
- Time after start of exposure: N/A

SCORING SYSTEM: Draize method (1959)
(1) Cornea
(A) Opacity - Degree of density (area most dense taken for reading)
No opacity ................................................................................ 0
Scattered or diffuse area, 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 invisible..................................................................4.*.
(B) 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.
A x B x 5 Total Maximum = 80

(2) Iris
(A) Values
Normal .................................................................................... 0
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris is still reacting to light (sluggish reaction is positive)……………..1*
No reaction to light, hemorrhage, gross destruction (any or all of these).................2*
A x 5 Total Maximum= 10

(3) 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 ............................................................................... O
Any swelling above normal (includes nictitating membrane).................................1
Obvious swelling with partial eversion of the lids ........................................ 2*
Swelling with lids about half closed....................................................3.*.
Swelling with lids about 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 the lids.................2
Discharge with moistening of the lids and hairs, and considerable area around the eye.....3
Score (A + B + C) x 2 Total Maximum = 20

The total score for the eye is the sum of all scores obtained for the cornea, iris, and conjunctivae.
* Indicates a positive effect. (FHSA Interpretation)

TOOL USED TO ASSESS SCORE: Sodium fluorescein examinations were used to aid in revealing possible corneal injury at 24 and 72 hours and days 7, 14, 21, and 28.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
24/48/72 h
Score:
43
Reversibility:
not fully reversible within: 28 days
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 96 hour
Score:
41
Reversibility:
not fully reversible within: 28 days
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
7 d
Score:
49
Reversibility:
not fully reversible within: 28 days
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
14 d
Score:
34
Reversibility:
not fully reversible within: 28 days
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
21 d
Score:
34
Reversibility:
not fully reversible within: 28 days
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 28 days
Score:
32
Reversibility:
not fully reversible within: 28 days
Irritant / corrosive response data:
The test article produced corneal and iridal involvement and severe conjunctival irritation. Ocular irritation was still present in the rabbit at day 28 after treatment. The sodium fluorescein examination at 24 and 72 hours was positive and at days 7, 14, 21 and 28 was negative. A maximum average primary eye irritation score of 49 of a possible 110.0 was assigned at the 7 day evaluation.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on the results of the study, the test article is corrosive to the eyes.
Executive summary:

The objective of this study was to assess the relative level of irritation/corrosion produced following a single exposure of a test material to one eye of an albino rabbit. The study was conducted according to OECD 405 (1981). One albino rabbit (New Zealand White strain) received 0.1 mL of the test article in the conjunctival sac of one eye. The contralateral eye served as an untreated control. The eye was evaluated for irritation at 1, 24, 48, 72 and 96 hours and at 7, 14, 21 and 28 days after treatment. At the 24 and 72 hour and 7, 14, 21 and 28 day evaluations, sodium fluorescein was used to aid in revealing possible corneal injury. The test article produced corneal and iridal involvement and severe conjunctival irritation. Ocular irritation was still present in the rabbit at day 28 after treatment. The sodium fluorescein examination at 24 and 72 hours was positive and at days 7, 14, 21 and 28 was negative. A maximum average primary eye irritation score of 49 of a possible 110.0 was assigned at the 7 day evaluation. Based on the results of the study, the test article is corrosive to the eyes.