Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented and scientifically good . Not according to GLP nor to specific test guidelines.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Principles of method if other than guideline:
A study was conducted to evaluate the acute dermal toxicity of the test material in rats. The rats were exposed to a dose of 2.000mg/kg bw of the tes material and observed during a period of 14 days
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Slags, lead-zinc smelting
EC Number:
297-907-9
EC Name:
Slags, lead-zinc smelting
Cas Number:
93763-87-2
Molecular formula:
not applicable
IUPAC Name:
Slags, lead-zinc smelting
Details on test material:
name of test substance: Ferrosita (Spanish brand name for Waelz-slag)
origin of test substance: Befasa Zinc Aser S.A.

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: firma Harlan
- Weight at study initiation: ± 190g
- Housing: individual cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Duration of exposure:
14 days observation period
Doses:
2000mg/kg bw
No. of animals per sex per dose:
4
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
no statistics reported

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths
Clinical signs:
no data
Body weight:
slight increases
Gross pathology:
no data
Other findings:
none

Any other information on results incl. tables

none              

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The sample Ferrosita is not harmful neither toxic via the dermal route
Executive summary:

This study report demonstrated no acute dermal toxicity for the sample 'Ferrosita'