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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
other: Body responsible of the test
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V, Micronucleous
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
(2R,3R)-3-((R)-1-(tert-butyldimethylsiloxy)ethyl)-4-oxoazetidin-2-yl acetate
EC Number:
408-050-9
EC Name:
(2R,3R)-3-((R)-1-(tert-butyldimethylsiloxy)ethyl)-4-oxoazetidin-2-yl acetate
Cas Number:
76855-69-1
Molecular formula:
C13H25NO4Si
IUPAC Name:
(2R,3R)-3-[(1R)-1-[(tert-butyldimethylsilyl)oxy]ethyl]-4-oxoazetidin-2-yl acetate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
mouse
Strain:
CD-1

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
Arachis oil BP
No. of animals per sex per dose:
Male: 50 mg/kg; No. of animals: 7; Sacrifice time: 24 hrs
Male: 100 mg/kg; No. of animals: 7; Sacrifice time: 24 hrs
Male: 200 mg/kg; No. of animals: 7; Sacrifice time: 24 hrs
Male: 50 mg/kg; No. of animals: 7; Sacrifice time: 48 hrs
Male: 100 mg/kg; No. of animals: 7; Sacrifice time: 48 hrs
Male: 200 mg/kg; No. of animals: 7; Sacrifice time: 48 hrs

Results and discussion

Any other information on results incl. tables

Doses producing toxicity: no change in P/N ratio

Other toxic signs: lethargy, hunched posture and decreased respiratory rate were noted with 200 mg/kg

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative