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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:
23 - 26 Feb 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

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
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: pale yellow liquid
- Analytical purity: 100% (UVCB)
- Lot/batch No.: N567701
- Storage condition of test material: at room temperature in the dark
- Other: density 860 g/m³

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: 8 weeks
- Weight at study initiation: 1.49-1.58 kg
- Housing: individually housed in labelled cages with perforated floors (Scanbur, Denmark)
- Diet: standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, the Netherlands), approximately 100 g/day. Hay (BMI, Helmond, the Netherlands) was provided once a week.
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 23 Feb 1998 To: 26 Feb 1998

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single application without washing
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eye was not washed after application

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: during the 24-hour reading time point, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal and the extent of corneal epithelial damage was assessed using a UV-light.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
At the 1-hour reading time point 3/3 rabbits had slight conjunctivae (score 1, 1, 1), which was still present in 1/3 rabbits at the 24-hour reading time point. The effect had cleared completely within 48 hours. No other eye irritation effects were observed in any rabbit at any time point (see Table 1).
Other effects:
There was no mortality, and no clinical signs were observed during the study period.

Any other information on results incl. tables

Table 1: Eye irritation scores

Rabbit #

 

Time [h]

 

conjunctivae

 

iris

 

cornea

 

redness

swelling

1

 

 

 

 

1

1 (AB)

0

0

0

24

1 (A)

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.33

0.0

0.0

0.0

2

 

 

 

 

1

1 (ABC)

0

0

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.00

0.0

0.0

0.0

3

 

 

 

 

1

1 (AB)

0

0

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.00

0.0

0.0

0.0

 

 

Time [h]

conjunctivae

 

iris

cornea

 

redness

swelling

 

 

average

score

1

1.00

0.00

0.00

0.00

24

0.33

0.00

0.00

0.00

48

0.00

0.00

0.00

0.00

72

0.00

0.00

0.00

0.00

24+48+72

0.11

0.00

0.00

0.00

A = eyelids

B = nictating membrane

C = sclera

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified