Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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 402 (adopted 1987)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Remarks:
(Harlan Laboratories Ltd)
Test type:
standard acute method
Limit test:
yes

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:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories Ltd.
- Age at study initiation: 9 (males) or 11 weeks (females)
- Weight at study initiation: 245-258 g (males) and 190-205 g (females)
- 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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 10% of the total body surface (one day before treatment, the backs of the animals were clipped with an electric clipper; re-shaved on test days 6, 9 and 13)
- % coverage: semi-occlusive dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
- Washing: dressing was removed and the skin was washed up with lukewarm tap water and dried with disposable paper toweis

TEST MATERIAL
undiluted test substance
Duration of exposure:
24 h
Doses:
7.12 mL of the liquid Biofert Plusz corresponding to 2000 mg/kg bw dry mass
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations (clinical signs including local effects): Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were reeorded.
- Frequency of weighing: On test days 1 (prior to administration), 8 and 15.
- Necropsy: yes, at termination (day 15)
- Other examinations performed: no
Statistics:
not used

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
other: dry mass
Remarks on result:
other: dose corresponds to 7.12 mL/kg bw of the liquid test substance; no clinical signs, no relevant effects on body weight, no findings at necropsy
Mortality:
no mortality
Clinical signs:
No clinical signs observed during the course of the study.
Body weight:
The body weight of the animals was within the range common1y recorded for this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.
Other findings:
no

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
In male and female Wistar rats the dermal LD50 is > 2000 mg/kg bw (related to dry mass).