Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Fixapret CP konz., PBG = 10073662, after Concentration
- Physical state:liquid (high viscous)
- Analytical purity: 89.6 %
- Lot/batch No.: 000335MCA0

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River WIGa GmbH, Sulzfeld, Germany
- Age at study initiation: male 8 weeks; female 12 weeks
- Housing: single housing
- Diet (e.g. ad libitum): VRF 1(P); SDS Special Diets Services (Altrip) Germany
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 26
- Humidity (%): 20 - 80 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: about 40 cm²
- % coverage: 10


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours


Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred
Clinical signs:
No systemic clinical sings were observed during clinical examination
Body weight:
The mean body weight of the animals increased within the normal range throughout the study period.
Gross pathology:
No abnormalities were noted.
Other findings:
Local effects:
Slightly yellowish discoloration of the application site was observed on study day 1 until study day 9 in all animals after application.

Applicant's summary and conclusion