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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
no
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Details on test material:
Sample No. DEH2005977

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
PEG 400
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: formulated in PEG 400
Duration of treatment / exposure:
24 h; 48 h
Frequency of treatment:
orally once
Doses / concentrationsopen allclose all
Dose / conc.:
500 mg/kg bw (total dose)
Dose / conc.:
1 000 mg/kg bw (total dose)
Dose / conc.:
2 000 mg/kg bw (total dose)
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Positive control(s):
cyclophosphamide
- Route of administration: orally
- Doses / concentrations: 40 mg/kg b.w.

Examinations

Tissues and cell types examined:
polychromatic erythrocytes (PCE)
Details of tissue and slide preparation:
CRITERIA FOR DOSE SELECTION:
The highest dose (2000 mg/kg) was estimated by a pre-experiment to be suitable; The animals treated with 2000 mg/kg b.w. expressed toxic reactions (ruffled fur);


Evaluation criteria:
the negative and positive controls are in the range of historical control data

Results and discussion

Test results
Key result
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
The registration substance was investigated for its clastogenicity in mouse according to the OECD Guideline 474. The registration substance did not induce increase of micronuclei in bone marrow cells in mouse.
Executive summary:

The registration substance was investigated for its clastogenicity in mouse according to the OECD Guideline 474. The registration substance was suspended in PEG and given to mouse per gavage at dose of 0, 500, 1000 and 2000 mg/kg. 24 or 48h after the treatment the bone marrow was collected and the polychromatic erythrocytes were investigated for the micronuclei. The treatment of up to the dose of 2000 mg/kg did not alter the number of polychromatic erythrocytes and the number of cells with microcleis. The registration substance did not induce increase of micronuclei in bone marrow cells in mouse.