Registration Dossier

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:
2002-05-27 until 2002-08-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Good laboratory practice guideline study (OECD).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): CAVASOL W6 HP
- Physical state: solid powder
- Analytical purity: 95.9% (GC)
- Impurities (identity and concentrations): as stated in substance data
- Composition of test material, percentage of components: as stated in substance data
- Lot/batch No.: 63B001
- Expiration date of the lot/batch: 2003-02-28
- Stability under test conditions: stable
- Storage condition of test material: in original container, 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: Harlan , Horst, The Netherlands
- Weight at study initiation: 1.7- 2.0 kg
- Age: At least 6 weeks old
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 °C
- Humidity (%): 30 - 70 % rel. humidity
- Air changes (per hr): 15/h
- Photoperiod (hrs dark / hrs light): 12hdark, 12 h light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untrated eye served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: as laid down in OECD Guideline 405


TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24 + 48 + 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24 + 48 + 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24 + 48 + 72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24 + 48 + 72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance has not to be classified as irritant according to the EU regulations.
Executive summary:

An eye irritation study was conducted with Cavasol W6 HP on three New Zealand White Rabbits by administering 0.1 ml of the substance. The mean scores of the 24, 48 and 72 hour readings did not exceed the limit values according to Directive 93/21 EEC in any case.