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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Genetic toxicity: in vivo

Currently viewing:

Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
publication
Title:
Effects of seven chemicals on DNA damage in the rats urinary bladder
Author:
Wada K., Yoshida, T., Takahashi, N.& Matasumoto, K.
Year:
2014
Bibliographic source:
CLH Report, Proposal for Harmomised classification and labelling
International Chemical identification: 2,2-BIS(BROMOMETHYL)PROPANE-1,3-DIOL
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
Deviations:
no
GLP compliance:
not specified
Remarks:
The source is publication and the information was not mentioned
Type of assay:
mammalian comet assay

Test material

Constituent 1
Reference substance name:
2,2-bis(bromomethyl)-1,3-propanediol
IUPAC Name:
2,2-bis(bromomethyl)-1,3-propanediol
Details on test material:
U-14C labeled BMP, in absolute ethanol (1mCi/ml) was obtained from Midwest Research Institute (Kansas City, MO). The radiochemical purity of BMP
was determined by reverse-phase HPLC-UV/visible-radiometric analysis to be 97.3%. The specific activity was reported to be 65.1mCi/mmol (247uCi/mg). Non radiolabeled BMP was obtained from Sigma-Aldrich (St. Louis, MO). Chemical purity of the unlabeled was 98%.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
none
Details on exposure:
Test substance was administered twice at 21 hours apart and animals were sacrificed 3 hours after the second administration.
Frequency of treatment:
Twice at 21 hours apart
Post exposure period:
3 hours
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (actual dose received)
Dose / conc.:
300 mg/kg bw/day (actual dose received)
Dose / conc.:
600 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
5/group

Results and discussion

Test results
Key result
Sex:
not specified
Genotoxicity:
positive
Remarks:
Positive in urinary bladder. Negative in liver.
Toxicity:
no effects

Applicant's summary and conclusion

Conclusions:
Positive in urinary bladder.
Negative in liver.
DNA damage (% tail DNA) in urinary bladder was increased in animals treated with the substance at high dose of 600mg/kg/day: significant (p<0.05).
No statistical increase was in the liver.
No decrease in body weight, no abnormal necropsy findings and no carcinogenic changes in urinary bladder was observed.
Executive summary:

In vivo mammalian alkaline comet assay (OECD 489) was performed on Spargue-Dawley rat males. the test substance was administered by oral gavage, at concentrations of 0, 300, 600 mg/kg/day, twice at 21 hours apart. Animals were sacrificed 3 hours after second administration. Comet assy was done on cells extraction from urinary bladder tissue. Histopathology was carried out on bladder samples from rats treated with 600 mg/kg/daytest substance. Results show positive (DNA damage was increased)  in urinary bladder and negative in liver. There was no decrease in body weight, no abnormal necropsy findings, and no carcinogenic changes in urinary bladder were observed.