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 Analytical purity not given, responsibility of the sponsor.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Analytical purity not reported, responsibility of the sponsor
GLP compliance:
yes (incl. certificate)
Remarks:
The Department of Health of the Government of the United Kingdom, 2009

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): HiPeaK
- Physical state: white powder
- Analytical purity: not given, responsibility of the sponsor
- Lot/batch No.: 9086
- Storage condition of test material: RT in the dark under nitrogen

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories Ltd., UK
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.03 - 2.50 kg
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL corresponding to 92 mg (as measured by gently compacting the required volume into an adapted syringe)

Duration of treatment / exposure:
Single treatment without washing
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 h
Other effects:
No systemic toxicity, abnormal body weight changes or clinical signs were observed during the study period.

Any other information on results incl. tables

Table 1: Individual scores

Rabbit No. / sex

Scoring [h]

Cornea

Iris

Conjunctiva

Redness

Chemosis

1

1

0

0

2

2

 

24

0

0

1

1

 

48

0

0

1

0

 

72

0

0

0

0

 

168

0

0

0

0

 

Mean 24-72 h

0

0

0.66

0.33

2

1

0

0

2

2

 

24

0

0

1

1

 

48

0

0

1

1

 

72

0

0

1

0

 

168

0

0

0

0

 

Mean 24-72 h

0

0

1

0.66

3

1

0

0

2

2

 

24

0

0

1

1

 

48

0

0

1

1

 

72

0

0

1

0

 

168

0

0

0

0

 

Mean 24-72 h

0

0

1

0.66

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Although slight, reversible irritation was observed, the test substance has not to be classified according to DSD and CLP.