Registration Dossier

Administrative data

Endpoint:
skin 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 404 (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 404 (Acute Dermal 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

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan France, 03800 Gannat / France
- Age at study initiation: 11 (one males) or 15 weeks (2 females)
- Weight at study initiation: 2178 g - 2916 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

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL liquid test item
- Concentration: undiluted liquid test substance

Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48, and 72 h after patch removal
Number of animals:
2 females and 1 male
Details on study design:
Four days and one day before treatment, the left flank was clipped with an electric clipper (no skin injury detected).
0.5 mL of Biofert Plusz placed on gauze patch (ca. 2.5 cm x 2.5 cm); gauze patch applied to the intact skin of the clipped area and patch covered with a semi-occlusive dressing; dressing wrapped around the abdomen and anchored with tape.
After 4 h exposure the dressing was removed and the skin was flushed with lukewarm tap water.
Scoring system according to Guideline.
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.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean after 24, 48, and 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean after 24, 48, and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean after 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation
Irritation parameter:
edema score
Basis:
animal: all 3 animals tested
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no edema
Irritant / corrosive response data:
One hour after patch removal all 3 animals showed erythema score 2 (well-defined erythema) but no edema. Individual results are presented in the Table below.
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

Skin irritation in rabbits after dermal application of Biofert Plusz

Parameter

Time after patch removal

Rabbit 1 (female)

Rabbit 2 (female)

Rabbit 3 (male)

Erythema

1 h

2

2

2

Erythema

24 h

1

1

0

Erythema

48 h

1

0

0

Erythema

72 h

0

0

0

Edema

1 h

0

0

0

Edema

24 h

0

0

0

Edema

48 h

0

0

0

Edema

72 h

0

0

0

 

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 skin.