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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:
6 February - 3 June 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Lot No. of test material: 07-170-FIL-2/3
- Appearance: White powder
- Expiration date: May 2010
- Purity: 98.4%
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Nichols Rabbitry Inc., Lumberton, TX
- Age at study initiation: Approx. 13 weeks old
- Weight at study initiation: Male: 2.7 kg; Females: 2.4 - 2.6 kg
- Housing: Suspended, wire bottom, stainless steel cage; 1 animal per cage
- Diet: PMI Feeds Inc. Lab Rabbit Diet #5321; 8 oz daily
- Water: Municipal water supply available ad libitum from automatic water system
- Acclimation period: Not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 12 air changes/ hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: From: 11 February 2008 To: 14 February 2008

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL by volume equivalent to 57.8 mg of test material
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
1 male and 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: All treated eyes were washed with room temperature deionised water for one minute immediately after recording the 24 hour observation.
- Time after start of exposure: 24 hours

OBSERVATIONS:
The treated eyes of all animals were examined without magnification under white room lighting provided by daylight-type fluorescent ceiling fixtures and (if needed) an additional source of white light affixed to the examination table or using a hand-held flashlight. The grades of ocular reaction were recorded at 1, 24, 48 and 72 hours after treatment. The corneas of all treated eyes were examined immediately after the 24 hour observation with a fluorescein sodium ophthalmic solution. Any of the corneas which exhibited fluorescein staining at the 24 hour observation were re-examined with the fluorescein sodium ophthalmic solution at each consecutive observation until fluorescein staining of the cornea no longer occurred.

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein sodium ophthalmic solution and a Finoff ocular transilluminator with cobalt blue filter

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: All animals
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
other: All animals
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
other: All animals
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
Rabbit No. 2300-M
Time point:
24 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
Rabbit No. 2295-F
Time point:
24 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
Rabbit No.
Time point:
24/48 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible
Irritant / corrosive response data:
There were no positive effects observed during the study. No irritation was observed in any eyes at 72 hours.
Other effects:
- Other observations: Fluorescein staining did not occur in any of the eyes.

- Actual temperature: 18 - 22°C
- Actual relative humidity: 41 - 84% (Humidity was outside of the protocol range but did not affect the study outcome)

Any other information on results incl. tables

Table 1: Ocular reactions

 

Rabbit No. 2300-M

Rabbit No. 2295-F

Rabbit No. 2297-F

 

Hours after treatment

Hours after treatment

Hours after treatment

 

1

24

48

72

1

24

48

72

1

24

48

72

I. Cornea

A. Opacity

0

0

0

0

+

0

0

0

+

0

0

0

B. Area

0

0

0

0

4

0

0

0

4

0

0

0

C. Fluorescein staining

-

0

-

-

-

0

-

-

-

0

-

-

D. Stippling

0

0

0

0

0

0

0

0

0

0

0

0

SCORE

0

0

0

0

0

0

0

0

0

0

0

0

II. Iris

A. Grade

0

0

0

0

0

0

0

0

0

0

0

0

SCORE

0

0

0

0

0

0

0

0

0

0

0

0

III. Conjunctivae

A. Redness

1

1

0

0

1t

1

0

0

1

1

1

0

B. Chemosis

0

0

0

0

0

0

0

0

0

0

0

0

C. Discharge

0

0

0

0

0

0

0

0

0

0

0

0

D. Necrosis or ulceration

0

0

0

0

0

0

0

0

0

0

0

0

SCORE

2

2

0

0

2

2

0

0

2

2

2

0

TOTAL SCORE

2

2

0

0

2

2

0

0

2

2

2

0

M – male

F – female

t – trace of test substance in eye

Duration of study: 72 hours

 

Table 2: Scores and score summary

Time after treatment

Rabbit Number

Average score

2300-M

2295-F

2297-F

Hour 1

2

2

2

2.0

Hour 24

2

2

2

2.0

Hour 48

0

0

2

0.7

Hour 72

0

0

0

0.0

Maximum average irritation score:

2.0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Formononetin is considered to be non-irritating to eyes.