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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: U.S. EPA Health Effects Test Guidelines OPPTS 870.2400
Deviations:
no
Qualifier:
according to
Guideline:
other: EEC Methods for the Determination of Toxicity Method B.5 Directive 92/69/EEC
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: not reported as such

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: Not reported
- Weight at study initiation: 2402, 2734 & 2657 g
- Housing: Singly in stainless steel, wire-mesh cages suspended above cage boards. Enrichment (e.g., toy) was placed in each cage
- Diet (e.g. ad libitum): Approximately 125 grams of Rabbit LabDiet® 5322 daily during the study
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22ºC
- Humidity (%): 30-70%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): approximate 12-hour light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye of each rabbit was not treated with the test substance and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
Approximately 30 to 60 seconds after exposure; then approximately 1, 24, 48, and 72 hours after treatment. One rabbit was further examined 7 and 14 days after treatment.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treated and control eyes of all rabbits remained unwashed.

SCORING SYSTEM: Draize Scale

TOOL USED TO ASSESS SCORE: Illumination and magnification, and fluorescein stain (24-hour and each subsequent evaluation).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: range
Time point:
other: 1 hour to 14 days
Score:
0
Irritation parameter:
iris score
Basis:
other: range
Time point:
other: 1 hour to 14 days
Score:
0 - 1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
other: range
Time point:
other: 1 hour to 14 days
Score:
1 - 2
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Conjunctival redness (score of 1 or 2), conjunctival chemosis (score of 1), and discharge (score of 1 or 2) were observed in the treated eye of all 3 rabbits. Additionally, iritis (score of 1) was observed in the treated eye of 2 rabbits. Fluorescein stain examinations were negative for corneal injury in the treated eye of all rabbits. The treated eye of the rabbits was normal by 24 hours, 48 hours, or 14 days after instillation of the test substance.
The ocular scores from individual animals with respect to observation time are presented in Table 1. Mean ocular scores calculated in accordance with EEC/GHS are presented in Table 2.
Other effects:
Two of the 3 rabbits pawed the treated eye after instillation of the test substance. One rabbit exhibited hair loss around the eye at 7 days. No clinical signs of systemic toxicity were observed and no body weight loss occurred.

Any other information on results incl. tables

Table 1

Individual Rabbit Ocular Irritation Scores Following Treatment with Test Substance

Reading

Rabbit

Number

Cornea

Iritis

Conjunctiva

Fluorescein

Stain

Opacity

Area

Redness

Chemosis

Discharge

1 Hour

341a

370

372

0

0

0

0

0

0

1

0

1

1

1

1

1

1

1

2

2

2

NA

NA

NA

24 Hours

341

370

372

0

0

0

0

0

0

0

0

0

0

1

2

0

0

1

0

2

2

NEG

NEG

NEG

48 Hours

341

370

372

0

0

0

0

0

0

0

0

0

0

0

1

0

0

1

0

0

1

NEG

NEG

NEG

72 Hours

341

370

372

0

0

0

0

0

0

0

0

0

0

0

1

0

0

1

0

0

0

NEG

NEG

NEG

7 Days

341

370

372

--

--

0

--

--

0

--

--

0

--

--

1

--

--

0

--

--

1

NA

NA

NEG

14 Days

341

370

372

--

--

0

--

--

0

--

--

0

--

--

0

--

--

0

--

--

0

NA

NA

NEG

NA = Not Applicable

NEG = Negative for corneal injury

-- = Not evaluated since all ocular irritation cleared prior to this timepoint

a = Initial rabbit tested

 

Table 2

Mean Scoresa for Ocular Responses for Individual Rabbits

Rabbit Number

Corneal Opacity

Iritis

Conjunctival Redness

Conjunctival Chemosis

341

370

372

0

0

0

0

0

0

0

0.33

1.33

0

0

1.0

a  24hr + 48 Hr + 72hr/3. Calculated according to EEC/GHS.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the test substance produced slight iritis and conjunctivitis when instilled into the rabbit eye. All irritation cleared by 14 days.
Executive summary:

The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand White rabbits. Two of the 3 rabbits pawed the treated eye after instillation of the test substance. Conjunctival redness (score of 1 or 2), conjunctival chemosis (score of 1), and discharge (score of 1 or 2) were observed in the treated eye of all 3 rabbits. Additionally, iritis (score of 1) was observed in the treated eye of 2 rabbits. Fluorescein stain examinations were negative for corneal injury in the treated eye of all rabbits. The treated eye of the rabbits was normal by 24 hours, 48 hours, or 14 days after instillation of the test substance. No clinical signs of systemic toxicity were observed, and no body weight loss occurred. One rabbit exhibited hair loss around the eye at 7 days. Under the conditions of this study, the test substance produced slight iritis and conjunctivitis when instilled into the rabbit eye. All irritation cleared by 14 days.