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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:
22 - 28 May 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 2012
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
adopted in 1998
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
adopted in 2008
GLP compliance:
yes (incl. certificate)
Remarks:
GYEMSZI National Institute for Quality- and Organizational Development in Healthcare and Medicines, Budapest, Hungary

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: S&K-LAP Kft., Kartal, Hungary
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: 2765 - 2803 g
- Housing: individual in AAALAC approved metal wire rabbit cages
- Diet: diet for rabbits (Agribands Europe Hungary PLC, Karcag, Hungary), ad libitum
- Water: municipal tap water, ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.1 - 20.1
- Humidity (%): 40 - 75
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
1 h
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The treated eye was rinsed with physiological saline solution.
- Time after start of exposure: 1 h

SCORING SYSTEM: Draize scoring system and OECD 405

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Other effects:
- Lesions and clinical observations: There were no mortalities and no clinical signs of systemic toxicity observed during the study. The general state and behaviour of animals were normal throughout the study period.
- Ophthalmoscopic findings: Fluorescein staining was negative in all animals during the observation period.
- Other observations: Discharge was noted 1 h post application in 3/3 males but was reversible within 24 h. The body weight and body weight changes were considered to be normal with no indication of any treatment related effect.

Any other information on results incl. tables

Table 1 Individual mean scores

Animal number

Effects

24 h

48 h

72 h

Mean scores

Response

Reversible (days)

1

Corneal opacity

Iritis

Redness conjunctivae

Chemosis conjunctivae

Discharge

0

0

1

1

0

0

0

1

0

0

0

0

0

0

0

0.00

0.00

0.67

0.33

0.00

-

-

-

-

-

na

na

3

2

1*

2

Corneal opacity

Iritis

Redness conjunctivae

Chemosis conjunctivae

Discharge

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0.00

0.00

0.33

0.00

0.00

-

-

-

-

-

na

na

2

1*

1*

3

Corneal opacity

Iritis

Redness conjunctivae

Chemosis conjunctivae

Discharge

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0.00

0.00

0.33

0.00

0.00

-

-

-

-

-

na

na

2

1*

1*

-- = negative, na = not applicable, * = in respect of the result 1 h post application

Applicant's summary and conclusion

Interpretation of results:
other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified