Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-11-11 until 1997-11-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Scientifically valid study according to GLP and current OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
, adopted 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
, adopted 1992
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Ltd, Hollister, CA
- Age at study initiation: 8 - 11 weeks
- Weight at study initiation: males: 273 - 297 g; femals: 224-252 g
- Housing: singly, suspended, stainless-steel, wire mesh cages
- Diet: Certified Rodent Diet (Purina Roden Chow #5002, pellets, ad libitum
- Water: drinking water, ad libitum, regulary analysed
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20-22°C
- Humidity: 49-50 %
- Photoperiod: 12 hours of artificial light

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal skin region
- % coverage: not less than 10 %
- Type of wrap if used: fiber pad and an occlusive wrap.

REMOVAL OF TEST SUBSTANCE
- Washing: using running water
- Time after start of exposure: 24 hours

TEST MATERIAL AND VEHICLE
The test substance was administered at a dose level of 2000 mg/kg bw

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 animals: 5 males, 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: systemically between days 0-14, body weights were recorded on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No adverse effects noted
Mortality:
No mortality was observed.
Clinical signs:
There were no signs of systemic reaction to treatment.
There were no signs of systemic toxicity.
Body weight:
All animals showed expected gains in bodyweitgh over the study period.
Gross pathology:
No abnormalities were noted.
Other findings:
none

Applicant's summary and conclusion