Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
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

Constituent 1
Reference substance name:
Iron silicate, copper smelting and refining
EC Number:
701-480-0
Cas Number:
67711-92-6
IUPAC Name:
Iron silicate, copper smelting and refining

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.