Manganese ores, reduced

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2003-1-24 to 2003-2-7

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP not specified but conducted to acceptable test standard

Cross-reference

Reason / purpose for cross-reference:

other: read-across target

Reference

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted on read-across material.

Reason / purpose for cross-reference:

read-across source

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mL/kg bw

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

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

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 or test system 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°
- Photoperiod (12hrs dark /12 hrs light):

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:

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: body weight,organ weights, histopathology, other: 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:

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 substance there was slight hair erection, which disappeared in 1-2 hrs. The activity and behaviour were not affected, and at the end of the14 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 were healed by themselves during the first week.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria.

Conclusions:

The acute dermal LD50 of the test material was determined to be in excess of 2000 mg/kg bw.

Executive summary:

The acute dermal toxicity of the read-across substance, silicomanganese slag, was assessed in a study which was conducted in line with the method outlined in the standardised guideline EU Method B.3.

No mortality was observed in Male/Female Sprague-Dawley Stain rats at concentration of 2000 mg/kg bodyweight. The acute dermal LD50 of the test material was therefore determined to be in excess of 2000 mg/kg bw.