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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Version April 24, 2002
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
Version August 1998
Deviations:
no
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nousan No. 8147, November 24, 2000 as this is in line with the OECD Guideline 405
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Identifier: CAS 80675-49-6
- Lot/batch No.: L-7015-20
- Yellow powder
- Storage conditions: Ambient temperature, no protection from light necessary
Specific details on test material used for the study:
- Identifier: CAS 80675-49-6
- Lot/batch No.: L-7015-20
- Analytical purity: 95%
- Yellow powder
- Storage conditions: Ambient temperature, no protection from light necessary

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: New Zealand white A 1077 INRA (SPF) rabbits from Centre Lago S. A., 01540 Vonnas, France.
- Age at study initiation: 5 – 6 months
- Weight at study initiation: 3.57 kg – 3.68 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area 3000 cm²
- Diet: 130 g/animal per day, Kliba-Labordiaet (Kaninchen & Meerschweinchenhaltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland
- Water: ad libitum, tap water
- Acclimation period: at least 5 days before application

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL bulk volume (about 17 mg of the comminuted test substance)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
Readings were performed approx. 1, 24, 48, and 72 h after application and weekly thereafter (max. up to day 28).
Number of animals or in vitro replicates:
2 female and 1 male rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the treated eye of each animal was rinsed with 3 to 6 mL of hand warm tap water for 1 - 2 minutes using a syringe with a blunt probe.
- Time after start of exposure: about 24 hours after application of the test substance

SCORING SYSTEM: according to the OECD Guideline 405

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all tested animals
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
all tested animals
Time point:
24/48 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all tested animals
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48 h
Score:
0
Max. score:
3
Irritant / corrosive response data:
- Slight conjunctival redness (grade 1) was observed in all animals 1 hour after application and persisted in one animal up to the 24-hour reading.
- Slight discharge (grade 1) was noted in all animals only 1 hour after application.
- The ocular reactions were reversible in two animals within 24 hours and in one animal within 48 hours after application.
Other effects:
In addition injected scleral vessels in a circumscribed area or circular were noted in the animals during the observation period.

Any other information on results incl. tables

Table 1: Individual ocular observations (only values until reversibility shown)

Readingperiods

Animal

Cornea

Iris

Conjunctivae

Opacity

Area involved

Redness

Chemosis

Discharge

 

After 1 hour

1

0

0

0

1

0

1

2

0

0

0

1

0

1

3

0

0

0

1

0

1

 

After 24 hours

1

0

0

0

0

0

0

2

0

0

0

1

0

0

3

0

0

0

0

0

0

 

After 48 hours

1

0

0

0

0

0

0

2

0

0

0

0

0

0

3

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met