Registration Dossier

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:
from 2003-01-27 to 2003-02-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted February 24, 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
92/69/EEC
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
August 1998
Deviations:
no
Qualifier:
according to
Guideline:
other: MAFF Testing Guideline of 12 Nosan No. 8147
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Uvinul A Plus
- Physical state at room temperature: pasty melt (occasionally solidified)
- Physical state at about 60°C: liquid, high viscous
- Colour at room temperature and at 60°C: Yellow
- Storage condition of test material: Room temperature, protected from light
- Analytical purity: 97.9 % (w/w) (purity verified by analysis)
- Lot/batch No.: 30956/121D2+/122D stripped
- Homogeneity: The test substance was homogeneous by visual inspection. Additionally, for a better handling the test substance was melted at about 60°C.
- Stability: The stability under storage conditions was determined by reanalysis.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Strain / quality: New Zealand White A1077 INRA (SPF)
- Sex: males and females
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: About 3 months
- Weight at study initiation: 2.30 - 2.61 kg
- Housing: Single housing. The animals were housed in fully air-conditioned rooms.
Stainless steel wire mesh cages with grating, floor area: 3000 cm2.
- Diet (e.g. ad libitum): Kliba laboratory diet, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: At least 5 days before beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2003-01-27 (first application) To: 2003-02-06

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: one eye of each animal was left untreated
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (undiluted)
- Temperature of the substance when volume to be applied is measured: 60°C
- Temperature of the substance when applied to eye: Cooled down to body temperature
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with tap water
- Time after start of exposure: 24 h

SCORING SYSTEM:
According to the quoted guidelines. In addition to specific observations recommended by regulatory authorities, evaluations were made of discharge from the eye and the area of cornea affected by the lesions.

Area of cornea involved (ar):*
1 = >0; <=1/4
2 = >1/4; <1/2
3 = >1/2; <3/4
4 = >3/4
* The assessment of these ocular reactions is performed independently of the quoted guidelines.

Discharge (di):*
0 = No discharge
1 = Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 = Discharge with moistening of the lids and hairs just adjacent to lids
3 = Discharge with moistening of the lids and hairs, and considerable area around the eye
* The assessment of these ocular reactions is performed independently of the quoted guidelines.

Description of any ocular findings not covered by this scale was recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24,48,72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24,48,72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24,48,72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24,48,72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 24,48,72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: 24,48,72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: 24,48,72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Mean scores calculated for all animals over 24, 48 and 72 hours were 0.0 for corneal opacity, iris lesions, chemosis, and discharge. The respective mean value for redness was 0.1.
Mean scores calculated individually for each animal over 24, 48 and 72 hours were always 0.0 for corneal opacity, iris lesions, chemosis, and discharge and redness, except for one animal for which a mean value for redness of 0.3 was recorded.
Other effects:
no other effects observed

Any other information on results incl. tables

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

Opacity

Area of cornea involved

Redness

Chemosis

Discharge

-

1h

01

0

0

0

1

0

1

-

02

0

0

0

2

0

1

-

03

0

0

0

2

0

2

-

24 h

01

0

0

0

0

0

0

-

02

0

0

0

0

0

0

-

03

0

0

0

1

0

0

-

48 h

01

0

0

0

0

0

0

-

02

0

0

0

0

0

0

-

03

0

0

0

0

0

0

-

72 h

01

0

0

0

0

0

0

-

02

0

0

0

0

0

0

-

03

0

0

0

0

0

0

-

Mean

01

0.0

-

0.0

0.0

0.0

-

-

02

0.0

-

0.0

0.0

0.0

-

-

03

0.0

-

0.0

0.3

0.0

-

-

Mean

-

0.0

-

0.0

0.1

0.0

-

-

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
According to the conditions of the test, the test substance has not to be classified as irritating to the eye following EU and the GHS requirements.