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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-518-7 | CAS number: 107-75-5
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Study of artificial flavouring substances for mutagenicity in the Salmonella/microsome, Basc and micronucleus tests
- Author:
- Wild D et al.
- Year:
- 1 983
- Bibliographic source:
- Food and Chemical Toxicology 21, 707– 719
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 7-hydroxycitronellal
- EC Number:
- 203-518-7
- EC Name:
- 7-hydroxycitronellal
- Cas Number:
- 107-75-5
- Molecular formula:
- C10H20O2
- IUPAC Name:
- 7-hydroxy-3,7-dimethyloctanal
- Details on test material:
- - Supplier: ICN-K&K, Plainview, NY, USA
No further data given
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 - 14 weeks
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: olive oil
- Duration of treatment / exposure:
- 30 h
- Frequency of treatment:
- once
- Post exposure period:
- 30 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
345, 603, 861 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 4 animals per dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- no data
Examinations
- Tissues and cell types examined:
- polychromatic erythrocytes of bone marrow
- Details of tissue and slide preparation:
- The smears were stained according to the method of Schmid (Schmid W. 1976; Chemical Mutagens; edited by A . Hollaender; Vol4; p31; Plenum Press, New York )
Slides were scored as described by Wild (Wild D. 1980; Archs Toxicol.; 43; 249). - Statistics:
- Statistical significance was determined according to the methods of Kastenbaum & Bowman (Kastenbaum M. 1970; Mutation Res. 9; 527)
Results and discussion
Test results
- Sex:
- female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
Any other information on results incl. tables
Results expressed as mean number of micronucleated polychromatic erythrocytes (PE) per 1000 PE:
345 mg/kg bw: 1.5 (4/4 animals survived)
603 mg/kg bw: 1.0 (4/4 animals survived)
861 mg/kg bw: 2.0 (4/4 animals survived)
vehicle control: 1.5 (4/4 animals survived)
mean of the vehicle controls for all substances tested: 1.85
A structurally and metabolically related substance (Hydroxycitronellol CAS. 107-74-4)
was tested under similar testing conditions:
516 mg/kg bw: 2.2 (4/4 animals survived)
860 mg/kg bw: 2.2 (4/4 animals survived)
1204 mg/kg bw: 2.6 (3/7 animals survived)
vehicle control: 2.0 (4/4 animals survived)
mean of the vehicle controls for all substances tested: 1.85
Applicant's summary and conclusion
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.
