Slags, nickel smelting

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented study performed according to internationally accepted method

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Principles of method if other than guideline:

Study was performed to assess the adverse effects of copper slag occurring after oral administration of a single dose of 2000 mg/kg/bw .

GLP compliance:

no

Remarks:

other quality assurance

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Slag, copper smelting

IUPAC Name:

Slag, copper smelting

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

The animals were kept to acclimate to laboratory conditions during the five days preceding the survey.
The rats were housed in a cage with individual identification. The diet was standard for these animals.
The temperature of the animal room was maintained at 22 + / - 3, the relative humidity in the range of 30-70% and also maintained a photoperiod of 12/12 light / dark

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Doses:

Single dose 2000 mg/kg/bw

No. of animals per sex per dose:

1

Control animals:

yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No

Other findings:

The animals survived and there were no changes in their behavior.

Any other information on results incl. tables

Table 1

Animal	Sample	Sex	Weight initial (g)	Weigh final (g)	Observation
1	control	female	150	189.5	-
2	sample	female	142.5	165	-

The animals survived and no changes observed in their behavior.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Good quality atudy. No negative effects were observed. An LD 50 of > 2000 mg/kg bw was assessed

Executive summary:

The oral toxicity of copper slag was assessed during an acute toxicity limit test with rat. The test was performed according to EU B1 Method (Limit-test). All test animals were exposed to 2000 mg copper slag/kg bodyweight, administered by the feed. After 14 days of observation, none of the animals showed negative effects. An LD 50 of > 2000 mg/kg bw was assessed.

Therefore copper slag is considered as nontoxic via oral route.