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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

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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:
1987

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

Constituent 1
Chemical structure
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

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