Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 Apr - 07 May 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Y-15866
- Physical state: colourless liquid
- Analytical purity: 72%
- Lot/batch No.: 3710-10
- Expiration date of the lot/batch: 2013-07-16
- Storage condition of test material: at room temperature (20 ± 5 °C) and light-protected
- Other: stability under storage conditions: yes

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories France, L’Arbresle, France and Charles River Deutschland GmbH, Kisslegg, Germany
- Age at study initiation: 22 weeks (male) and 12-15 weeks (females)
- Weight at study initiation: 4025 g (male) and 2618-2680 g (females)
- Housing: animals were housed individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet: pelleted standard Kliba Nafag 3418 rodent maintenance diet (batch no. 05/10, Provimi Kliba AG, Kaiseraugst, Switzerland), ad libitum. A piece of wood (batch no. 102240, ABEDD® - LAB & VET GmbH, Vienna, Austria) and a haystick 4642 (batch no. 54/09, Provimi Kliba AG, Kaiseraugst, Switzerland) were also provided for each animal.
- Water: community tap water from Füllinsdorf, Switzerland, ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 03 May 2010 (one female) or 04 May 2010 (the male and the second female) To: 07 May 2010

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
5 (one male and one female) or 6 days (one female)
reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
1 male and 2 females
Details on study design:
SCORING SYSTEM: according to the numerical scoring system listed in the Commission Regulation (EC) No 440/2008, B.5, Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean after 24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Slight reddening of the conjunctivae was noted in all animals 1 h after instillation and persisted in one female at the 24 h reading. Slight reddening of the sclerae was noted in the male and one female at the 1 h reading. At the same observation point, slight swelling of the conjunctivae was also present in this female. No abnormal findings were observed in the cornea or for the iris light reflex. No corrosion and no staining were observed in the treated eyes.
Other effects:
No further local or systemic effects were observed.

Any other information on results incl. tables

Table 1. Results of eye irritation study (individual scores)

Rabbit #

Time [h]

conjunctivae

iris

cornea

redness

chemosis

1

1

1

0

0

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0

0

0

0

2

1

1

1

0

0

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.33

0

0

0

3

1

1

0

0

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Executive summary:

The eye irritation potential of Y-15866 was investigated in a study according to OECD guideline 405 and in compliance with GLP. The undiluted test substance (0.1 mL) was placed into the conjunctival sac of the left eye of 3 young adult New Zealand White rabbits (1 male and 2 females). Scoring of irritation effects was performed approximately 1, 24, 48 and 72 h after test substance instillation. The instillation of Y-15866 into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, as well as chemosis. These effects were reversible and were no longer evident up to 48 h after treatment. No abnormal findings were observed in the cornea or for the iris light reflex of any animals at any of the examinations. No corrosion and no staining of the treated eyes and no clinical signs were observed. The individual mean scores after 24, 48 and 72 h for corneal opacity and iris light reflex were 0 for all three animals. The individual mean scores after 24, 48 and 72 h for the conjunctivae were 0, 0.33 and 0 for reddening, respectively, and 0 for chemosis for all 3 animals.