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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:
20 November 2001 - 30 November 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Test was conducted according to OECD Test Guideline No. 405, 1987, under GLP Standards, and QA.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Directive 92/69/EEC
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
1998
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Remarks:
Statement of Compliance

Test material

Constituent 1
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Locron P
- Physical state: white powder
- Analytical purity: confidential
- Lot/batch No.: confidential
- Stability under test conditions: no data
- Storage condition of test material: at approx. 20 °C in a fume cupboard

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: no data
- Weight at study initiation: 2.9 - 3.2 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
At 1, 24, 48, and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed out thoroughly with isotonic saline at approx. 37 °C
- Time after start of exposure: 24 hours and at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed

SCORING SYSTEM: subjective numerical according to OECD Guideline 405 (corneal (opacity and area), iridic and conjunctival irritation (redness/chemosis/discharge)).

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
One hour up to 48 hours after administration the conjunctivae of all animals showed definitely injected blood vessels up to diffuse crimson color, so that individual vessels were not easily discernible. Swelling with lids about half closed was observed in all animals one hour after administration. In addition, serious-colorless eye discharge was noted. 72 hours after administration all signs of irritation had completely disappeared.
Other effects:
None

Any other information on results incl. tables

Table 7.3.2 Individual scores

 

1h

24h

48h

72h

Mean 24/48/72h

Corneal opacity

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

Iris

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

Redness

2 / 2 / 2

2 / 2 / 2

1 / 1 / 1

0 / 0 / 0

1 / 1 / 1

Chemosis

3 / 3 / 3

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

Discharge

2 / 2 / 2

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test material Locron P is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Executive summary:

An eye irritation study was performed according to OECD Guideline 405 and in compliance with GLP. One eye of three rabbits each was exposed to 0.1g of the test substance for 24 hours. Observation occurred at 1, 24, 48 and 72 hours. One hour up to 48 hours after administration the conjunctivae of all animals showed definitely injected blood vessels up to diffuse crimson color, so that individual vessels were not easily discernible. Swelling with lids about half closed was observed in all animals one hour after administration. In addition, serous-colorless eye discharge was noted. 72 hours after administration all signs of irritation had completely disappeared.

Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0 / 0.0 / 0.0 for cornea score; 0.0 / 0.0 / 0.0 for iris score; 1.0 / 1.0 / 1.0 for conjunctivae score and 0.0 / 0.0 / 0.0 for chemosis score.

Under the test conditions, the test material Locron P is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.