Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 Apr - 19 May 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 guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 1987
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit und Soziales, Hamburg, Germany

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: approx. 5.5 months
- Weight at study initiation: 2.2-2.3 kg
- Housing: during the acclimatisation period and after the 8-hour period in restrainers (allowed free movement of the head but prevented a complete body turn), the animals were kept singly in cages (425 mm x 600 mm x 380 mm)
- Diet: ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, Soest, Germany); available ad libitum before and after the exposure period
- Water: tap water; availble ad libitum before and after the exposure period
- Acclimation period: at least 20 days

ENVIRONMENTAL CONDITIONS
- according to guideline

IN-LIFE DATES: From: 28 Apr 2003 To: 19 May 2003

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated left eyes served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
up to 72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE:
not rinsed

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp (prior to administration and 1, 24, 48 and 72 h after administration) and fluorescein (24 hours after administration)

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 h
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 h
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 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
The cornea, iris and conjunctivae were not affected by instillation of the compound.
Other effects:
There were no systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Under the conditions of this eye irritation study in the rabbit the test item did not cause any reaction to cornea, iris and conjunctivae.