Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-11-21 to 1991-02-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

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

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: Broekman Institute, Someren, The Netherlands.
- Age at study initiation: Approx. 12 weeks
- Weight at study initiation: 2789 - 2953 grams
- Housing: Individually in cages with perforated floors equipped with an automatic drinking-system
- Diet (e.g. ad libitum): Standard laboratory rabbit diet approx. 100 gram per day.
- Water (e.g. ad libitum): Free access to tap-water diluted with decalcified water.
- Acclimation period: At least five days before start of treatment under test conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 55%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 1990-11-21 To: 1990-12-03

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
48 h
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Immediately after fluorescein examination on day 2, both eyes of all three animals were rlnsed with approx 100 ml tepid tap-water
- Time after start of exposure: 48 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Max. score:
2
Reversibility:
not fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: overall at 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:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Reversibility of any observed irritating effect: Changes fully reversible within 7 days.
There was no evidence of ocular corrosion.
Other effects:
Blue discolouration of iris, eyelids (treated eye) and fur.
No toxic symptoms were observed i n the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information mildly irritating (M2) Criteria used for interpretation of results: EU
Conclusions:
The test substance should be considered mildly irritating (M2) to the rabbit eye. According to the EEC criteria for classification and labelling requirements for dangerous substances (EEC Directive 83/467/EEC), the substance needs not be labelled as an eye irritant. The same conclusion applies to the new CLP regulation EC 1272/2008.