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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Study period:
2007
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 2000/32/EG, B.12; OECD 474 (1997)
Deviations:
no
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
according guideline

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
Corn oil. Test substance concentrations were blended and
treated with ultra-sonic waves to obtain a homogeneous
suspension.
Duration of treatment / exposure:
animals received the test item once
Frequency of treatment:
once
Post exposure period:
24h, 48 h
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
15 mg/kg bw
Basis:
other: injection
Remarks:
Doses / Concentrations:
7,5 mg/kg bw
Basis:
other: injection
Remarks:
Doses / Concentrations:
3,8 mg/kg bw
Basis:
other: injection
No. of animals per sex per dose:
Male: 15 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 15 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 7.5 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 3.8 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Female: 15 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 15 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 7.5 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 3.8 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Control animals:
yes, concurrent vehicle
Positive control(s):
yes, treated with cyclophosphamide dissolved in physiological saline dosed as a single intraperitoneal injection of 50 mg/kg bw.

Results and discussion

Test results
Sex:
male/female
Toxicity:
yes
Remarks:
Doses producing toxicity: Toxic signs at the highest tested dose of 15 mg/kg; weakly cytotoxic (PCE/NCE) at 15 mg/kg (48 h sampling time).
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Observations:
No lethal effects.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The substance is not subject of classification and labeling.