Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Sep 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP 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)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: female
- Source: Charles River, 88353 Kißlegg, Germany
- Age at study initiation: not specified
- Weight at study initiation: 3.2-3.8 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 55 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye, which remained untreated, served as control
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
test substance remained in the eye (eye was not rinsed)
Observation period (in vivo):
1, 24, 48 and 72 hours after instillation
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1,2,3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: mean score after 72 hours: 0.0
Irritation parameter:
iris score
Basis:
animal: #1,2,3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: mean score after 72 hours: 0.0
Irritation parameter:
chemosis score
Basis:
animal: #1,2,3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: mean score after 72 hours: 0.0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0 - 2
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: mean score after 72 hours: 1.0
Irritation parameter:
conjunctivae score
Basis:
animal: #2,3
Time point:
other: 24, 48, 72 h
Score:
0 - 1
Max. score:
3
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: mean score after 72 hours: 0.3
Irritant / corrosive response data:
Redness of conjunctivae (grade 1) was observed in all animals 1 hour after instillation. At that time point chemosis of conjunctivae (grade 1) was observed in two animals. The fluorescein test performed after 24 hours revealed no corneal effects.
Other effects:
No relevant systemic intolerance reactions were observed.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Executive summary:

In an eye irritation study according to OECD TG 405 the test substance was instilled into the conjunctival sac of one eye of 3 female rabbits. Eye irritation was assessed after 1, 24, 48 and 72 hours using the Draize scale. In this study BAY 43-9006 shows slight irritant effects (mean irritation index for conjunctivae score = up to 1.0 of max. 3) which were fully reversible within 3 days. No irritation effects were registered for cornea, iris and conjunctival chemosis 24 to 72 hours after instillation. The weight of these evidences indicates that the test substance may be considered as "slightly irritating to the eyes". No systemic intolerance reactions were observed.

According to classification criteria BAY 43-9006 is not an irritant to the eyes.