Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 May 2004 to 09 July 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
April 24, 2002
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
29 December, 1992
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
August, 1998
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nousan No. 8147, November 24, 2000 as this is in line with OECD 405.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: Solid, powder / white
- Homogeneity: The test substance was homogeneous by visual inspection.
Specific details on test material used for the study:
TEST MATERIAL
- Name of the test substance used in the study report: DKDS - Reinkristallisat
- Purity: 96.8 w/w%
- pH value: 4.5 (10% aqueous preparation)
- Batch No.: CP 203-362-04-02
- Appearance: Solid, powder / white
- Homogeneity: The test substance was homogeneous by visual inspection.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature. The stability under storage conditions was confirmed by reanalysis

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
Al 077 INRA (SPF)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: 5 - 6 months
- Weight at study initiation: 3.20 kg - 3.66 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2.
- Diet: Kliba-Labordiaet (Kaninchen & Meerschweinchenhaltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water: Tap water ad libitum
- Acclimatization period: At least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 % relative humidity
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 mL bulk volume (about 27 mg of the comminuted test substance)
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
- Route of application: The test substance was applied in a single dose to the conjunctival sac of the right eyelid.
- Rinsing of the eye: About 1 hour after application of the solid test substance the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Readings: Approx. 1, 24, 48 and 72 h after application.
- Illumination used for reading: Daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany)
- Body weight determination: Just before application of the test substance and after the last reading.
- Check for dead or moribund animals: Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
At 24 hours, scleral vessels were injected, in circumscribed area, in animals #2 and #3.

Any other information on results incl. tables

CLINICAL EXAMINATIONS AND ASSESSMENT OF OCULAR FINDINGS

Slight or moderate conjunctival redness (grade 1 or 2) as well as slight conjunctival chemosis (grade 1) were observed in all animals 1 hour after application. In two animals slight conjunctival redness and chemosis persisted up to the 24-hour reading. Slight or moderate discharge (grade 1 or 2) was noted in two animals 1 hour after application. In addition scleral vessels injected in a circumscribed area or circular were noted in the animals up to 24 hours after application. The ocular reactions were reversible in one animal within 24 hours and in two animais within 48 hours after application.

Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0 for corneal opacity and for iris lesions and 0.0, 0.3 and 0.3 for redness of the conjunctiva and for chemosis.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met