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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Copper Monochloride CAS No: 7758-89-6, Final 10/2006
Author:
OECD SIDS
Year:
2006
Reference Type:
other: Study cited in OECD SIDS
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes
Type of assay:
other: Mammalian erythrocyte micronucleus test

Test material

Constituent 1
Chemical structure
Reference substance name:
Copper chloride
EC Number:
231-842-9
EC Name:
Copper chloride
Cas Number:
7758-89-6
Molecular formula:
Cl Cu
IUPAC Name:
λ¹-copper(1+) chloride
Details on test material:
- Name of test material (as cited in study report): Copper monochloride (CuCl),
- Analytical purity: purity 99%
- Lot/batch No.: Sigma-Aldrich corporation, LOT No. 17119BO

Test animals

Species:
mouse
Strain:
ICR
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: 8 weeks
- Weight at study initiation: no data

ENVIRONMENTAL CONDITIONS
- no data

Administration / exposure

Route of administration:
other: negative control: oral gavage; positive control: intraperitoneal injection
Vehicle:
- Vehicle(s)/solvent(s) used: 0.5 % CMC (carboxymethyl cellulose);
- Lot/batch no. (if required): LOT No.-32K0007
Details on exposure:
PREPARATION OF DOSING SOLUTIONS:
- no data

DIET PREPARATION
- no data
Duration of treatment / exposure:
single exposure
Frequency of treatment:
duplicate treatments (only positive control group was dosed once)
Post exposure period:
24 h
Doses / concentrations
Remarks:
Doses / Concentrations:
Three dose levels, 15, 30 and 60 mg/kg bw/day, were determined for the micronucleus experiment based on the results of dose range finding experiment
Basis:

No. of animals per sex per dose:
6
Control animals:
yes, concurrent vehicle
Positive control(s):
mitomycin C;
- Route of administration: intraperitoneal injection
- Doses / concentrations: 2.0 mg/kg of Mitomycin C

Examinations

Tissues and cell types examined:
polychromatic erythrocytes
Details of tissue and slide preparation:
CRITERIA FOR DOSE SELECTION:
dose range finding experiment

Evaluation criteria:
at least 1,000 polychromatic erythrocytes per animals were scored for the incidence of micronuclei.
Statistics:
Chi-square test (using a 2 × 2 contingency table)

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
not specified
Positive controls validity:
valid

Any other information on results incl. tables

All animals dosed with copper monochloride exhibited similar PCE/(PCE + NCE) ratios and MNPCE frequencies compared to those of negative control animals. All frequencies of MNPCE in the negative control groups fell
within acceptable ranges, while the positive control groups induced clear increase in the frequencies of MNPCE.

Applicant's summary and conclusion