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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:
2000-01-26 to 2000-02-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
February 24, 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
29 December 1992
Deviations:
no
GLP compliance:
yes

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: Charles River Wiga GmbH, Kißlegg, Germany
- Age at study initiation: about 16 weeks
- Weight at study initiation: 3.41 kg (range from 3.34 to 3.52)
- Housing: separately in special rabbit cages (manufacturer: Becker; type K99/30 KU, floor area about 5400 cm², a shelter with an integrated sitting board of about 1820 cm²; overall height: 60 cm)
- Diet: ad libitum, pellets (Altromin Standard Diet TPFW 2113)
- Water: ad libitum, tap water
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 37 - 64
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
CORNEA
Opacity: degree of density (area most dense taken for reading)
0 no ulceration or opacity
1 scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 easily discernible translucent area, details of iris slightly obscured
3 nacreous areas, no details of iris visible, size of pupil barely discernible
4 Opaque cornea, iris not discernible through the opacity

IRIS
0 normal
1 markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 no reaction to light, haemorrhage, gross destruction (any or all of these)

CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
0 blood vessels normal
1 some blood vessels definitely hyperaemic (injected)
2 diffuse, crimson colour, individual vessels not easily discernible
3 diffuse beefy red

Chemosis: lids and/or nictitating membrane
0 no swelling
1 any swelling above normal (including nictitating membranes)
2 obvious swelling with partial eversion of lids
3 swelling with lids about half-closed
4 swelling with lids more than half-closed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation were observed in the cornea and iris. The conjunctivae showed redness (score 1) in two rabbits during hour one of the study. Furthermore no signs of irritation were observed. The untreated eyes were unchanged.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the conducted study, the test substance is not regarded as irritant to the eyes.
Executive summary:

In a primary eye irritation study in accordance with OECD guideline 405 and EU method B.5, 0.1 mL of the undiluted test substance was instilled into the conjunctival sac of the right eye of three female New Zealand White rabbits. The eyes were not washed. Animals were then observed for up to 8 days. Irritation was scored by the method of Draize:

 

 

Mean score
(24, 48, and 72 hours)

Maximum value
(24, 48, or 72 hours)

Animal No.

 

7

8

9

7

8

9

Cornea

A

0.00

0.00

0.00

0

0

0

Iris

A

0.00

0.00

0.00

0

0

0

Conjunctivae

A

0.00

0.00

0.00

0

0

0

 

B

0.00

0.00

0.00

0

0

0

No signs of irritation were observed in the cornea and iris. The conjunctivae showed redness (score 1) in two rabbits during hour one of the study. Furthermore no signs of irritation were observed. The untreated eyes were unchanged. Based on the above results the test substance was non-irritating to eyes.