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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 800-181-3 | CAS number: 371756-75-1
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2006-02-22 to 2006-03-15
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 476-99-6
- IUPAC Name:
- 476-99-6
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- deionised water
- Details on exposure:
- substance formulated in vehicle
- Duration of treatment / exposure:
- animals received the test item once
- Frequency of treatment:
- once
- Post exposure period:
- 24 h, 48 h
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
2000 mg/kg body weight
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg body weight
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
500 mg/kg body weight
Basis:
actual ingested
- No. of animals per sex per dose:
- main experiment:
high dose: 24 animals (12 males/12 females)
mid dose: 12 animals (6 males/6 females)
low dose: 12 animals (6 males/6 females) - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide, 40 mg/kg b.w; 24 h;
Examinations
- Tissues and cell types examined:
- bone marrow cells; polychromatic erythrocytes; normochromatic erythrocytes
- Details of tissue and slide preparation:
- according guideline
- Evaluation criteria:
- standard
- Statistics:
- nonparametric Mann-Whitney test
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- within 1 h after treatment with 2000 mg/kg b.w.
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Based on the experimental conditions reported the oral application of the substance to mice did not induce micronuclei as determined by the micronucleus test in the bone marrow cells (polychromatic erythrocytes).
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.
