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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
1 (reliable without restriction)
Justification for type of information:
Copper is the ion which will be interesest in toxiocolgy matters. So here will be make a data waiving form copper silfate pentahydrate to copper hydroxide nitrate
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
Deviations:
no
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Reference substance name:
7758-99-8
Cas Number:
7758-99-8
IUPAC Name:
7758-99-8
Constituent 2
Reference substance name:
copper sulfate pentahydrate
IUPAC Name:
copper sulfate pentahydrate
Details on test material:
CAS# 7758-99-8, c=99-100in %

Test animals

Species:
other: rat and mice
Strain:
other: rat: F344/N; mice: B6C3F
Sex:
not specified

Administration / exposure

Route of administration:
other:
Vehicle:
other:
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
drinking water: 2 weeks
dosed feed: 2 and 13 weeks
Frequency of treatment:
rats:
mice:
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0, 300, 1000, 3000, 10000 ppm
Basis:
other: 2 weeks, in drinkiing water
Remarks:
Doses / Concentrations:
0, 1000, 2000, 4000, 8000, 16000 ppm
Basis:
other: 2 weeks, in diet feed
Remarks:
Doses / Concentrations:
0,, 500, 1000, 2000, 4000, 8000 ppm
Basis:
other: 13 weeks, in diet feed
Remarks:
Doses / Concentrations:
0, 1000, 2000, 4000, 8000, 16000 ppm
Basis:
other: 13 weeks, in diet feed, group for special pathology
No. of animals per sex per dose:
rats: 5 per sex and dose
mice: 5 per sex and dose
Control animals:
yes

Results and discussion

Effect levels

open allclose all
Dose descriptor:
NOEL
Effect level:
1 000 ppm
Sex:
male/female
Basis for effect level:
other: rat
Dose descriptor:
NOEL
Effect level:
2 000 ppm
Sex:
male/female
Basis for effect level:
other: mice

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
In summary, under the exposure conditions employed in this study, ingestination of cupric sulfate in drinking water or feed produced hyperplasia and hyoerkeratois of the forestomach mucossia (irritant effect of the substance).
There is a copper accumulation in liver, kidney tissue and the plasma.
There was determined a NOEL value from 1000ppm for rat ant 2000ppm for mice.