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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
and EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. QA statement)
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 or test system 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