Slags, silicomanganese-manufg.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-1-24 to 2003-2-7

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A non-GLP study performed to a standardised guideline with a sufficient level of detail to assess the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

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

Test material information

Constituent 1

Reference substance name:

Slags, silicomanganese-manufg.

EC Number:

273-733-9

EC Name:

Slags, silicomanganese-manufg.

Cas Number:

69012-33-5

Molecular formula:

UVCB identified to contain the following formulae: Na2O, MgO, Al2O3, SiO2, P2O5, K2O, CaO, TiO2, V2O5, Cr2O3, Fe2O3,BaO, ZrO2, ZnO, SrO, SiMn

IUPAC Name:

Slags, silicomanganese-manufacturing

Details on test material:

- Name of test material (as cited in study report): Slag SiMn
- Appearance: Greenish Solid
- Lot/batch No.: 002/AN-03

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Weight at study initiation: 91.3 -99.7 g (males); 94.0 - 101.8 g (females)
- 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 SUBSTANCE
- 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:

5 males and 5 females

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: body weight, organ weights, histopathology, general condition, external alterations

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:

other: Not reported

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 substance there was slight hair erection, which disappeared in 1-2 hrs. 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 substance but these healed by themselves during the first week.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study the acute dermal LD50 of the test substance was determined to be in excess of 2000 mg/kg bw.

Executive summary:

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

During the study 5 male and 5 female rats received a dermal application of 2000 mg/kg bw test substance. Twenty four hours after application the test site was washed to remove the test substance. The animals were observed for a further 13 days. No mortality occurred during the study and no adverse clinical signs were reported. Body weight gains appeared normal.

Therefore, under the conditions of the study the acute dermal LD50 of the substance was determined to be in excess of 2000 mg/kg bw.