Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Directive 83/467/EEC.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Electrode binder [CAS No. 65996-93-2]
- Name of test material (as cited in study report): 101.110
- Substance type: organic
- Physical state: solid, black powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, Bremerförde/Germany
- Age at study initiation: no data
- Weight at study initiation: 2.4 - 2.6 kg
- Housing: cage, single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 7 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +-2 °C
- Humidity (%): 50 - 86 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
other: none
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Observation period (in vivo):
1, 24, 48, and 72 h post-application
Number of animals or in vitro replicates:
6
Details on study design:
Comment: not rinsed
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed


SCORING SYSTEM: according to Draize


TOOL USED TO ASSESS SCORE: hand-slit lamp: no data / biomicroscope: no data / fluorescein: after 24 and 72 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal: #1 - #5
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
animal: #1, #3, #4
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal: #2, #5, #6
Time point:
other: 1 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
No irritation effects after 24 h (scores 0)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU