Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 206-337-1 | CAS number: 328-84-7
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- February 24th, 1992 to June 1st, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Test material form:
- liquid
- Details on test material:
- Clear colourless liquid
- Specific details on test material used for the study:
- Purity 99.7 %
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPFbreeding colony
- Strain: Hoe: NMRKf (SPF71)
- Age at study initiation: 7 weeks
- Weight at study initiation: males: 25 g - 33 g (average 28.7 g); females: 21 g - 26 g (average 23.5 g)
- Housing: 5 animals per makrolon cage
- Diet: Altromin 1324 rat/mice diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/- 20%
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Sesame oil
Concentration of test material in vehicle: 25 mg/mL
Amount of vehicle: 10 mL/kg bw - Post exposure period:
- 24, 48, 72 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 500 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Positive control(s):
- Endoxan R (cyclophosphamide)
- Route of administration: oral
- Doses / concentrations: 50 mg/kg bw
Examinations
- Tissues and cell types examined:
- Polychromatic erythrocytes gained from femoral bone marrow.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The results indicate that, under the conditions of the present study, 3,4-dichlorobenzotrifluoride is not mutagenic in the micronucleus test.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
