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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 437-970-3 | CAS number: 371921-62-9
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
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
- Reference substance name:
- Red 0106-PP1
- IUPAC Name:
- Red 0106-PP1
Constituent 1
Test animals
- Species:
- mouse
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- Corn oil
- No. of animals per sex per dose:
- Male: 500 mg/kg; No. of animals: 6; Sacrifice time: 24 hours
Male: 1000 mg/kg; No. of animals: 6; Sacrifice time: 24 hours
Male: 2000 mg/kg; No. of animals: 6; Sacrifice time: 24 hours
Male: 2000 mg/kg; No. of animals: 6; Sacrifice time: 48 hours
Female: 500 mg/kg; No. of animals: 6; Sacrifice times: 24 hours
Female: 1000 mg/kg; No. of animals: 6; Sacrifice times: 24 hours
Female: 2000 mg/kg; No. of animals: 6; Sacrifice times: 24 hours
Female: 2000 mg/kg; No. of animals: 6; Sacrifice times: 48 hours
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- Doses producing toxicity: The animals in the preliminary test exposed to 2000 mg/Kg b.w. doses expressed toxic reactions. The animals in the main test exposed to 2000 mg/Kg b.w. expressed toxic reactions.
- Additional information on results:
- Observations:
After treatment with RED 0106-PP1the number of normochromatic erythrocytes (NCE) was not substantially increased as compared to the mean value of NCEs of the vehicle control thus indicating that the test item did not exert any cytotoxic effects in the bone marrow.
In comparison to the corresponding vehicle controls there was no statistically significant or biologically relevant enhancement in the frequency of the detected micronuclei at any preparation interval and dose level after administration of the test item. The mean values of micronuclei observed after treatment with RED 0106-PP1 were near the value of the vehicle control group.
Applicant's summary and conclusion
- Conclusions:
- Non mutagenic
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.
