Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to OECD guideline 405 (adopted 2002)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
(Harlan Laboratories Ltd.)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Biofert Plusz
Details are presented in "Confidential details on test material"

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan France, 03800 Gannat / France
- Age at study initiation: 12 (one males) or 14 weeks (2 females)
- Weight at study initiation: 2158 – 3101 g
- Housing: individually
- certified diet ad libitum
- tap water ad libitum
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
according to guideline

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: eye, which remains untreated, serves as a control
Amount / concentration applied:
TEST MATERIAL
- Amount: 0.1 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
no washing
Observation period (in vivo):
Scoring 1, 24, 48, and 72 h after instillation
Number of animals or in vitro replicates:
1 male and 2 females
Details on study design:
No signs of ocular injury or irritationin any test animal.
On the day of treatment, 0.1 mL of Biofert Plusz (containing 0.028 g of the dry mass) was placed in the conjunctival sac of the left eye of each animal.
SCORING SYSTEM: according to Guideline
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp
Body Weights: At start of acclimatization, on the day of application and at termination of observation.
Clinical Signs: Daily from acclimatization of the animals to the termination of test.
No necropsy was performed on the animals sacrificed at termination of observation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean after 24, 48, and 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: additionally no effects on iris and cornea and no chemosis
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean after 24, 48, and 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: no effects on iris and cornea and no chemosis
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean after 24, 48, and 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: no effects on iris and cornea and no chemosis
Irritant / corrosive response data:
No abnormal findings in the cornea or iris of any animal at any of the scoring intervals; slight reddening of the conjunctivae (score 1) noted in all three animals 1 h after treatment and persisted in two animals for up to 48 h; slight swelling (chemosis) of the conjunctivae in one female only 1 hour after instillation. Slight reddening of the sclerae was present in all animals 1 hour after treatment. All effects reversible 72 h after instillation. No staining produced by the test item.
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the study.
The body weights of all rabbits were considered to be within the normal range of variability.

Any other information on results incl. tables

Grading of effects on conjunctiva after instillation of 0.1 mL Biofert Plusz
(data refer to rabbit no. 1, 2, and 3, respectively)

 

Effect

 

Draize scores of each rabbit (n=3) at different times after instillation of test material

1 hour

1 day

2 days

3 days

Redness

1 / 1 / 1

0 / 1 / 1

0 / 1 / 1

0 / 0 / 0

Chemosis

0 / 1 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

No effects on cornea and iris

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Biofert Plusz is not irritant to the eye.