Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 January 2003 to 7 February 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
A non-GLP study performed to a standardised guideline with a sufficient level of detail to assess the quality of the relevant results. Since the study was conducted with silicomanganese slag, rather than with the registered substance itself, it has been assigned a reliability score of 2 in line with the criteria of Klimisch (1997). Use of data generated with silicomanganese slag, to address information requirements of ferromanganese slag, is considered to be justified on the basis of the similar compositions of the two substances. Both substances are UVCB substances, containing metallic oxides; each substance is obtained as a by-product in the manufacture of SiMn and FeMn alloy, respectively.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
yes
Remarks:
(no raw data for each animal)
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Slag SiMn
- Physical state: Greenish Solid
- Lot/batch No.: 002/AN-03

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males 91.3 -99.7 g; females 94.0 - 101.8 g
- Housing: polypropylene cages with vents on top, with dimensions 445(w) x 695 (l) x 290(h) allowing 10 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C



Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal region
- % coverage: >10%
- Type of wrap if used: gauze pad and hypoallergenic medical tape

REMOVAL OF TEST MATERIAL
- Washing (if done): with water
- Time after start of exposure: 24 hr

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2mL of substance aqueous suspension
- For solids, paste formed: no


Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
Five
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: performed but no details
- Necropsy of survivors performed: yes
- Other examinations performed: general condition, external alterations, body weight, organ weights, histopathology
Statistics:
Not reported

Results and discussion

Preliminary study:
A previous study conducted several years earlier gave no mortality at 400 mg/kg and thus the use of 2000 mg/kg for this study.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
Not reported
Body weight:
The rate of body weight increase did not differ significantly from control
Gross pathology:
No apparent macroscopic injuries in any of the observed organs. Colour and consistency were normal.
Other findings:
- Other observations:
General condition: After the administration of the test material there was slight hair erection, which disappeared in 1-2 hours. The activity and behaviour were not affected, and at the end of the 14 days they were normal.

External alterations: No changes were detected in the health status of the conjunctiva and mucous membranes. Initially superficial injuries were observed in the dorsal area that was in contact with the test material but these healed by themselves during the first week.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the acute dermal LD50 of SiMn slag was estimated to be greater than 2000 mg/kg in male and female rats.
Executive summary:

The acute dermal toxicity of tSiMn slag was investigated in a study which was conducted in accordance with the standardised guideline EU Method B.3.

Under the conditions of the study the acute dermal median lethal dose (LD50) of the test material in male and female rats was determined to be greater than 2000 mg/kg bw.

Since the study was conducted with silicomanganese slag, rather than with the registered substance itself, it has been assigned a reliability score of 2 in line with the criteria of Klimisch (1997). Use of data generated with silicomanganese slag, to address information requirements of ferromanganese slag, is considered to be justified on the basis of the similar compositions of the two substances. Both substances are UVCB substances, containing metallic oxides; each substance is obtained as a by-product in the manufacture of SiMn and FeMn alloy, respectively.