Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
and EU Method B.3 (Acute Toxicity (Dermal))
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:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: males: 329 ± 4 g
females: 215 ± 3 g
- Fasting period before study: overnight
- Housing: one to seven of the same sex / cage during acclimation period and 3 rats individual housing
during the treatment period in polycarbonate cages with stainless steel lid (48 x 27 x 20 cm)
- Bedding: autoclaved sawdust (by SICSA, France)
- Diet (e.g. ad libitum): ad libitum, pellets by SSNIFF Spezialdiäten GmbH, Germany
- Water (e.g. ad libitum): ad libitum, drinking water, filtered
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 C
- Humidity (%): 30-70 %
- Air changes (per hr): 12 / hour (filtered, non-recycled air)
- Photoperiod (hrs dark / hrs light): 12/12 h

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal
- % coverage: 10
- Type of wrap if used: hydrophilic gauze pad, held on with an adhesive hypoallergenic aerated semi-occlusive dressing
and restraining bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): removal of residual test item: by using a dry cotton pad (no washing)
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg / kg in its original form in a single dose
- Constant volume or concentration used: yes
- For solids, paste formed: moistened with purified water


VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle
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
- Frequency of observations: frequently during the hours following treatment. At least once a day thereafter.
and weighing: on days 1, 8 and 15
- Necropsy of survivors performed: yes (macroscopic examinations)
- Other examinations performed: local reactions

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
No clinical signs. No cutaneous reactions.
Body weight:
Slightly reduced in females.
Gross pathology:
No abnormalities.
Other findings:
-

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU