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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
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:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
no
Remarks:
other quality assurance
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals 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.
Approximately 24 hours before the test, fur was be removed by shaving from the dorsal area.

Administration / exposure

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

3

control

female

150

189.5

No dermal reaction

4

sample

female

165.5

192

No dermal reaction

 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 study. No negative effects were observed. An LD 50 of > 2000 mg/kg bw was assessed
Executive summary:

The dermal toxicity of copper slag was assessed during an acute toxicity limit test with rat. The test was performed according to EU B3 Method (Limit-test). All test animals were exposed to 2000 mg copper slag/kg bodyweight. 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 dermal route.