Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-06-20 to 2006-10-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-study according to OECD test guideline 402

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
February 1987
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation, India
- Age at study initiation: 10 to 11 weeks
- Weight at study initiation:Male : Minimum: 283, Maximum: 298, Female : Minimum: 237, Maximum: 266
- Fasting period before study: no
- Housing: individually in polypropylene rat cages covered with stainless steel grid tops
- Diet: Rat pellet feed (Amrut brand), was provided ad libitum
- Water: Drinking water filtered through an Aquaguard water filter system was provided ad libitum.
- Acclimation period: 6 days prior to dosing.

ENVIRONMENTAL CONDITIONS
- Temperature: :19 to 23 °C
- Humidity: 64 to 67 %
- Air changes: minimum 15 air changes/h
- Photoperiod: photoperiod was 12 h artificial light and 12 h darkness, light hours being 06:00 h -18:00 h

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: approx. 10% of body area
- Type of wrap if used: porous gauze dressing and non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: cotton moistened with distilled water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw
- Constant volume or concentration used: yes

Duration of exposure:
24h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2, 3 and 6 hours post dermal application on day 0; from day 1 twice/day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
none
Body weight:
comparable gain in treated and control group
Gross pathology:
no findings in treated group

Applicant's summary and conclusion