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:
2005-07-26 to 2005-11-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
2004
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
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 OECD 405
Version / remarks:
2000
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: V3186/11

Letter of Confirmation: CAS No 90530-15-7 and 93940-97-7 refer to the same substance and substance composition.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: 3 - 4 months
- Weight at study initiation: 2 .79 kg - 3 .18 kg
- Housing: single housing, Stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet: Kliba-Labordiät (Kaninchen & Meerschweinchenhaltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water: Tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 -70
- Air changes: fully air conditioned rooms
- Photoperiod (hrs dark / hrs light): 12 h light (6.00 a.m. - 6.00 p.m.) 12 h darkness (6.00 p.m . - 6.00 a.m.)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Duration of treatment / exposure:
About 24 hours after application of the liquid test substance the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
Observation period (in vivo):
Readings: Approx. 1, 24, 48 and 72 h after application and then in weekly intervals maximally up to day 28.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: rinsing with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe
- Time after start of exposure: 24 h

SCORING SYSTEM: according to guidelines. The evaluation is based on the criteria of Annex VI of the Commission Directive 67/548/EEC that were in place on the date of report signature.

TOOL USED TO ASSESS SCORE: illumination used for reading: Daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible

Any other information on results incl. tables

Table 1. Individual Scores

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

opacity

Area of cornea involved

redness

chemosis

Discharge

1 h

01

0

0

0

2

2

2

49

02

0

0

0

2

2

2

 

03

0

0

0

2

2

2

49

24 h

01

1

4

1

2

2

1

PC, 48

02

1

4

1

1

1

2

PC, 48

03

1

4

1

2

2

1

PC, 48

48 h

01

1

3

1

1

1

1

PC, 48

02

1

3

0

1

1

0

PC, 48

03

1

3

0

2

2

1

PC, 48

72 h

01

1

2

0

1

1

0

PC, 48

02

1

2

0

1

1

0

PC, 48

03

1

2

0

1

1

0

PC, 48

7 d

01

0

0

0

0

0

0

 

02

0

0

0

0

0

0

 

03

0

0

0

0

0

0

 

Mean

24 – 72 h

01

1.0

 

0.7

1.3

1.3

 

 

02

1.0

 

0.3

1.0

1.0

 

 

03

1.0

 

0.3

1.7

1.7

 

 

Mean

 

1.0

 

0.4

1.3

1.3

 

 

Explanation of findings:

PC = Pupil contracted

48 = Scleral vessels injected, circumscribed area

49 = Scleral vessels injected, circular

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria