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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-2005
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
2007
Reference Type:
publication
Title:
Unnamed
Year:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
In order to substantiate this evaluation, the Tecarn-Tecnologia Ambiental Ltda accredited before the Ministry of Agriculture and is holder of bio-safety certificates.
BOS samples were collected in CST´s processing plants. The crushed stone is from Brasitalia quarry, located in the municipality of Serra, Brasilia. Crushed stone samples were collected and prepared by the company Kaerne Engenharia Ltda. In compliance with the method defined in NBR 10.007.2007.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Duration of exposure:
24 h, consecutive observation period 14 d
Doses:
their skin treated with the maximum dosage recommended for each product (4000 mg/kg)
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
The animals were individually observed with special attention during the first 24 h after the administration of the test substance and for a period of 14 d when they were observed 7 d a week if evident signs were found, or 5 d a week when toxicity signs were not evident. The symptoms to be observed were alterations in the skin, fur, eyes and mucous membranes, dyspnoea, behaviour alterations, tremors, convulsions, salivation, diarrhea, lethargy, sleepiness, coma and death. In the case of mortality, the records include the approximate time of death.

Results and discussion

Preliminary study:
As it was known that there is no evidence of dermal toxicity, main test was made with maximum possible concentration of slags and crushed natural stone
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality reported
Clinical signs:
no clinical signs reported
Body weight:
no data
Gross pathology:
no data
Other findings:
The monitoring of the animals included observation for alternations in the skin, fur, eyes and mucous membranes dyspnoea, behaviour alternations, tremors, convulsions, salivation, diarrhoea, lethargy, sleepiness, coma, and death. In case of death, the time of death would have been reported.

Any other information on results incl. tables

BOS LD50 > 4000 mg/kg

Crushed stone: LD50 > 4000 mg/kg

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
BOS: rats OECD 402: LD50 > 4000 mg/kg
Crushed natural stone: rats OECD 402: LD50 > 4000 mg/kg
Executive summary:

To test the dermal toxicity of slags, steelmaking, converter (BOS) and crushed stone from a quarry in the vicinity of Serra, Brasilia, tests were performed following OECD guideline 402 in Wistar rats. Fine-ground BOS and crushed stone were dosed, in their original form, at 4 g/kg bw (body weight) under semi-occlusive dressing for 24 h. After dosing, the patches were removed and the animals were observed for a post exposure period of 14 days. The LD50 was > 4000 mg/kg bw for each test material.

Slags, steelmaking, converter (BOS) and natural stone from a quarry in Serra, Brasilia, are not toxic via the dermal route, and do not need to be classified as dermal toxicants. No signal word and no hazard statement is required.