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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:
28 Jan 1989 - 1 Mar 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study (OECD)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
RCC BNOTOX B.V., 's-Hertogenbosch, The Netherlands

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Prifrac 2922
- Analytical purity: not specified
- Physical state: solid
- Storage condition of test material: at room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: ca. 14 weeks
- Weight at study initiation: 2670 - 2834 g
- Housing: individually in cages with perforated floors
- Diet (e.g. ad libitum): pelleted standard LKK-20 rabbit maintenance diet (Hope Farms, Woerden, The Netherlands), ca. 100 g/day
- Water (e.g. ad libitum): tap water diluted with decalcified water; ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 7.5 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 52.45 +/- 0.45 mg
Duration of treatment / exposure:
single application
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
According to Draize (1944)

TOOL USED TO ASSESS SCORE: fluorescein (2% in water; 24 hours after application and on days 4, 8, 15 and 22 in all animals)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean 24 - 72 h
Score:
0.9
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean 24 - 72 h
Score:
0.8
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean 24 - 72 h
Score:
2.9
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean 24 - 72 h
Score:
1.6
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritant / corrosive response data:
No corrosion was observed.
Other effects:
- Lacrimation was observed in all animals.
- Fluorescein treatment revealed corneal epithelial damage in all animals at all time points.
- No toxic symptoms were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Readings:

Time point Animal Corneal Opacity Iris Conjunctival  Discharge Additional findings
Opacity Area Erythema Edema
1 h 1 1 4 1 0 3 0 L
2 2 4 1 0 3 0 L
3 1 4 1 0 3 0 L
24 h 1 1 1 1 3 2 1 L
2 1 4 1 3 2 1 L
3 1 1 1 3 1 1 L
48 h 1 1 3 0 3 1 2 L
2 1 2 1 3 1 2 L
3 0 2 0 3 1 2 L
72 h 1 1 4 1 3 2 3 L
2 1 4 1 2 2 3 L
3 1 2 1 3 2 3 L
7 days 1 2 4 0 3 1 1 v
2 2 4 0 2 1 0 v
3 2 1 0 3 1 0 v
14 days 1 2 3 0 1 0 1 v
2 2 3 0 1 0 0 v
3 2 1 0 2 1 0 v
21 days 1 1 4 0 1 0 0 v
2 2 1 0 1 0 0 v
3 2 1 0 1 0 0 v
mean 24 - 48 hours 1 1.0 2.7 0.7 3.0 1.7 2.0
2 1.0 3.3 1.0 2.7 1.7 2.0
3 0.7 1.7 0.7 3.0 1.3 2.0
Mean 0.9 0.8 2.9 1.6

L: lacrimation

V: neovascularisation on the cornea

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU