Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 Aug - 28 Aug 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 2012
Deviations:
yes
Remarks:
no anesthetics and systemic analgesics used
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
adopted 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
adopted August 1998
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), November 2000
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): AF-654
- Physical state: white powder
- Lot/batch No.: #CE-201
- Expiration date of the lot/batch: 01 Jan 2005
- 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: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 1.651 - 1.785 kg
- Housing: individually in labelled cages with perforated floors (Scanbur, Denmark)
- Diet: standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany), approximately 100 g per day and pressed hay twice a week
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.4 - 22.2
- Humidity (%): 43 - 89
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: not required: the untreated eye of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 16.8 mg (15.8 - 17.7 mg) (corresponding to a volume of approximately 0.1 mL)
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
72 hours
reading time points: 1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: 2% fluorescein in water (pH 7.0)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
Irritation of the conjunctivae was seen as redness, chemosis and discharge for all animals 1 hour after instillation. Redness was still visible 24 hours after instillation but was completely reversed thereafter. No iridial irritation or cornea opacity were observed. Treatment of the eyes with 2%
fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.
Other effects:
No staining of ocular tissues by the test substance was observed.
Remnants of the test substance were present in the eyes of two animals and on the outside of the eyelid in one animal on day 1.
No mortality and no symptoms of systemic toxicity were observed.

Any other information on results incl. tables

Table 1. Results of eye irritation study.

 

Rabbit #

 

Time [h]

 

conjunctivae

 

iris

 

cornea

 

 

conjunctivae

 

iris

 

cornea

 

redness

swelling

redness

swelling

1

 

 

 

 

1

2

1

0

0

 

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.3

0.0

0.0

0.0

Time to reversion

48.0

24.0

0.0

0.0

2

 

 

 

 

1

1

1

0

0

 

 

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.3

0.0

0.0

0.0

Time to reversion

48.0

24.0

0.0

0.0

3

 

 

 

 

1

2

1

0

0

 

 

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.3

0.0

0.0

0.0

Time to reversion

48.0

24.0

0.0

0.0

 

 

 

Time [h]

conjunctivae

 

iris

cornea

 

redness

swelling

 

 

avg. time to reversion

48.0

24.0

0.0

0.0

average

score

1

1.67

1.00

0.00

0.00

 

24

1.00

0.00

0.00

0.00

48

0.00

0.00

0.00

0.00

72

0.00

0.00

0.00

0.00

24+48+72

0.33

0.00

0.00

0.00

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: not classified
CLP: not classified