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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 248-131-4 | CAS number: 26952-14-7
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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-09-22 to 1992-11-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is rated "reliable with restrictions" because though this study did not specify the use of GLP guidance it was conducted in close accordance to OECD TG 474
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-09-22 to 1992-11-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is rated "reliable with restrictions" because though this study did not specify the use of GLP guidance it was conducted in close accordance to OECD TG 474
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Route of administration:
- inhalation: vapour
- Vehicle:
- - Vehicle(s)/solvent(s) used: Air
- Concentration of test material in vehicle: 1000 ppm - Duration of treatment / exposure:
- 6 hours/day
- Frequency of treatment:
- Daily for 10 consecutive days
- Post exposure period:
- Samples collected 24 hours post last exposure
- Remarks:
- Doses / Concentrations:
1000 ppm
Basis: - No. of animals per sex per dose:
- 5/sex/dose group
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
- Justification for choice of positive control(s): Not provided
- Route of administration: Oral gavage
- Doses / concentrations: 40 mg/kg - Tissues and cell types examined:
- Bone marrow suspended in fetal bovine serum; 1000 polychromatic erythrocytes (PCE) were examined from each exposed animal for the presence of micronuclei. In addition, the ratio of PCEs to NCEs were determined for each animal by counting 1000 erythrocytes (PCEs and NCEs)
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- MRD 92-321 did not induce a statistically significant decrease in the mean percent of polychromatic erythrocytes which is a measure of bone marrow toxicity. Hence, the test chemical was not toxic to the B6C3F1 mouse bone marrow.
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- negative
MRD 92-321 did not induce a statistically significant decrease in the mean percent of polychromatic erythrocytes which is a measure of bone marrow toxicity. Hence, the test chemical was not toxic to the B6C3F1 mouse bone marrow under the conditions of the test. The test material also did not induce a statistically significant increase in the mean number of micronucleated polychromatic erythrocytes. Based on these results, the test material is not clastogenic to the bone marrow of the B6C3F1 mouse. - Executive summary:
In an in-vivo micronucleus assay, five male and five female B6C3F1 mice were exposed nose only for six hours/day for ten consecutive days to 1000 ppm of MRD 92-321 (C6 alkene) in air. The positive control, cyclophosphamide in water, was administered via oral gavage at a dose of 40 mg/kg, while air served as the negative control. Bone marrow samples were collected at approximately 24 hours after the last exposure and evaluated for micronucleus formation.
MRD 92-321 did not induce a statistically significant decrease in the mean percent of polychromatic erythrocytes which is a measure of bone marrow toxicity. The test material also did not induce a statistically significant increase in the mean number of micronucleated polychromatic erythrocytes. The positive and negative control gave appropriate results. Based on these results, the test material is not clastogenic to the bone marrow of the B6C3F1 mouse.
This study received a Klimisch score of 2 and is classified as “reliable with restrictions” because though this study did not specify the use of GLP guidance it was conducted in close accordance to OECD TG 474.
[This study was selected as a supporting study because …………………]
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Alkenes, C6
- IUPAC Name:
- Alkenes, C6
- Reference substance name:
- Alkenes, C6-
- EC Number:
- 271-208-9
- EC Name:
- Alkenes, C6-
- Cas Number:
- 68526-52-3
- IUPAC Name:
- Alkenes, C6-
- Details on test material:
- - Name of test material (as cited in study report): MRD 92-321 (C6 Alkene; hexene)
- Substance type: Alkenes, C6
- Physical state: Colourless liquid
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: vapour
- Vehicle:
- - Vehicle(s)/solvent(s) used: Air
- Concentration of test material in vehicle: 1000 ppm - Duration of treatment / exposure:
- 6 hours/day
- Frequency of treatment:
- Daily for 10 consecutive days
- Post exposure period:
- Samples collected 24 hours post last exposure
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000 ppm
Basis:
- No. of animals per sex per dose:
- 5/sex/dose group
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
- Justification for choice of positive control(s): Not provided
- Route of administration: Oral gavage
- Doses / concentrations: 40 mg/kg
Examinations
- Tissues and cell types examined:
- Bone marrow suspended in fetal bovine serum; 1000 polychromatic erythrocytes (PCE) were examined from each exposed animal for the presence of micronuclei. In addition, the ratio of PCEs to NCEs were determined for each animal by counting 1000 erythrocytes (PCEs and NCEs)
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- MRD 92-321 did not induce a statistically significant decrease in the mean percent of polychromatic erythrocytes which is a measure of bone marrow toxicity. Hence, the test chemical was not toxic to the B6C3F1 mouse bone marrow.
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- negative
MRD 92-321 did not induce a statistically significant decrease in the mean percent of polychromatic erythrocytes which is a measure of bone marrow toxicity. Hence, the test chemical was not toxic to the B6C3F1 mouse bone marrow under the conditions of the test. The test material also did not induce a statistically significant increase in the mean number of micronucleated polychromatic erythrocytes. Based on these results, the test material is not clastogenic to the bone marrow of the B6C3F1 mouse. - Executive summary:
In an in-vivo micronucleus assay, five male and five female B6C3F1 mice were exposed nose only for six hours/day for ten consecutive days to 1000 ppm of MRD 92-321 (C6 alkene) in air. The positive control, cyclophosphamide in water, was administered via oral gavage at a dose of 40 mg/kg, while air served as the negative control. Bone marrow samples were collected at approximately 24 hours after the last exposure and evaluated for micronucleus formation.
MRD 92-321 did not induce a statistically significant decrease in the mean percent of polychromatic erythrocytes which is a measure of bone marrow toxicity. The test material also did not induce a statistically significant increase in the mean number of micronucleated polychromatic erythrocytes. The positive and negative control gave appropriate results. Based on these results, the test material is not clastogenic to the bone marrow of the B6C3F1 mouse.
This study received a Klimisch score of 2 and is classified as “reliable with restrictions” because though this study did not specify the use of GLP guidance it was conducted in close accordance to OECD TG 474.
[This study was selected as a supporting study because …………………]
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.
