Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study according to OECD guideline 402 (adopted 1987). Study was originally judged Klimisch 1. However, according to the "Practical guide 6: How to report read-across and categories" the maximum score for read-across is 2.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
other: Commission Directive 92/69/EEC, B.3
GLP compliance:
yes
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 - 11 weeks
-Weight at study initiation: 190 - 258 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

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:
-Post-observation period: 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 recorded.
-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:
None
Clinical signs:
No adverse effects
Body weight:
No adverse effects
Gross pathology:
No adverse effects

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The acute dermal toxicity of Biofert Plusz was tested in GLP study according to OECD guideline 402. In both male and female Wistar rats the dermal LD50 (related to dry mass) is > 2000 mg/kg bw