Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Analogue substance tested; GLP study using standard method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

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
- Source: D. Percival, Moston, Cheshire, UK
- Age at study initiation:12 - 16 weeks
- Weight at study initiation: 2,68 -3,08 kg
- Housing: individual
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: > 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 -21 C
- Humidity (%): 62 -65 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL = ca 81 mg

Duration of treatment / exposure:
4 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Annex VI of 67/548 EG

TOOL USED TO ASSESS SCORE: none

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
> 0.3 - < 0.7
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
> 0.3 - < 0.7
Max. score:
2
Reversibility:
fully reversible within: < 48 h
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
Residual test material was noted in all treated eyes at the
1-hour observation and in two treated eyes at the 24-hour
observation and one treated eye at the 48-hour observation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU
Conclusions:
An analogue substance produced only mild transient effects on the eyes of rabbits. The substance is not expected to cause significant eye irritation.