Registration Dossier
Registration Dossier
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: 249-596-6 | CAS number: 29385-43-1
Toxicological information
Genetic toxicity: in vivo
Currently viewing:
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed and documented study, no Guideline mentioned but equivalent to Guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Methyl-1H-benzotriazole
- EC Number:
- 249-596-6
- EC Name:
- Methyl-1H-benzotriazole
- Cas Number:
- 29385-43-1
- Molecular formula:
- C7H7N3
- IUPAC Name:
- 5-methyl-1H-1,2,3-benzotriazole
- Test material form:
- solid: pellets
- Details on test material:
- - Name of test material (as cited in study report): Preventol CI 7-100
- Physical state: solid
- Analytical purity: 99.3 %
- Composition of test material, percentage of components: 40 % 4-Methylbenzotriazole and 60 % 5-Metyhlbenzotriazole
- Storage condition of test material: at 4 °C
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 31 - 44 g
- Assigned to test groups randomly: [yes, under following basis: company randomising plan]
- Housing: standard Kakrolon cages type I and II
- Diet: Altromin 1324 ad libitum
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 2°C
- Humidity (%): 50 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: Polyethylenglycole
- Justification for choice of solvent/vehicle: suitable solvent for Tolyltriazole
- Concentration of test material in vehicle: no data
- Amount of vehicle (if gavage or dermal): no data - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: the test item was solved in polyethylene glycol and
administered by gavage - Duration of treatment / exposure:
- not applicable
- Frequency of treatment:
- once
- Post exposure period:
- 24 / 48 / 72 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
600 mg / kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Justification for choice of positive control(s): common substance, reommended by the OECD Guideline
- Route of administration: gavage
- Doses / concentrations: 20 mg / kg bw
Examinations
- Tissues and cell types examined:
- bone marrow from the femur
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: a range finding study indicated the dose
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
DETAILS OF SLIDE PREPARATION:
The bonemarrow is purged with fetal calve serum
Dyeing with an Ames Hema-Tek Slide Stainer
METHOD OF ANALYSIS:
manual counting with a microscope (magnification 1000) - Evaluation criteria:
- for the test item the number of polychromatic cells with micro nuclei is compared to the controls
A difference is significant, if the error probability is below 5 % - Statistics:
- distrribution free rank sum test according to wilcoxon
Chi2-Test
Mean values and 1s-range
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 500 - 1000 mg/kg bw
- Clinical signs of toxicity in test animals: apathy, horrent fur, narcotic state, prone position, spasm, breathlessness
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): normal
- Ratio of NCE/PCE (for Micronucleus assay): 1000:1715
Any other information on results incl. tables
| Group | evaluable polychromatic Erythrocytes | Ratio NCE/PCE | Micronuclei per 1000 NCE | Micronuclei per 1000 PCE |
| negative control | 10000 | 1320 | 0.5 | 1.2 |
| Tolyltriazole, 24 h | 10000 | 1540 | 0.9 | 1.7 |
| Tolyltriazole, 48 h | 10000 | 1715 | 0.6 | 1.4 |
| Tolyltriazole, 72 h | 10000 | 994 | 0.5 | 1.0 |
| positive control | 10000 | 1393 | 0.8 | 14.7 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Tolyltriazole does not show genetic toxicity in this study.
Toxic effects were observed in a range finding study at 750 mg /kg bw
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.
