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EC number: 262-104-4 | CAS number: 60207-90-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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
- Study period:
- 16 Aug 1999 to 18 Nov 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 21 July 1997
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5395 (In Vivo Mammalian Cytogenetics Tests: Erythrocyte Micronucleus Assay)
- Version / remarks:
- August 1998
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 31 July 1992
- Qualifier:
- according to guideline
- Guideline:
- other: MITI, Ministry of International Trade and Industry, Japan, 62 Notification of Basic Industries Bureau, No. 303, (Sho-62)
- Version / remarks:
- 31 March 1987
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole
- EC Number:
- 262-104-4
- EC Name:
- 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole
- Cas Number:
- 60207-90-1
- Molecular formula:
- C15H17Cl2N3O2
- IUPAC Name:
- 1-{[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl}-1H-1,2,4-triazole
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Ico:CD1(CRL)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adults, 7 - 8 weeks old
- Weight at study initiation: 33-39 g males, 24-29 g females
- Housing: 5 animals per cage
- Diet: Certified standard diet, ad libitum
- Water: Tap water ad libitum
- Acclimation period: The animals were kept on location for at least five days prior to being used in the study. Shortly before use the health status of the animals was checked by the laboratory personnel according to veterinary/scientific standards.
ENVIRONMENTAL CONDITIONS
- Temperature: 20.5-22.0°C
- Humidity: 50-79%
- Air changes (per hr): Not reported
- Photoperiod: 12 hours dark/12 hours light
IN-LIFE DATES: 16 Aug 1999 to 18 Nov 1999
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle used: arachis oil
- Concentration of test material in vehicle: 16, 32, 64 mg/mL
- Amount of vehicle: 5 mL/kg bw - Frequency of treatment:
- Single dose
- Post exposure period:
- 24 hours (all groups) and 48 hours (high dose group and negative control group only)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 80 mg/kg bw (total dose)
- Remarks:
- Low dose group
- Dose / conc.:
- 160 mg/kg bw (total dose)
- Remarks:
- Mid dose group
- Dose / conc.:
- 320 mg/kg bw (total dose)
- Remarks:
- High dose group
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Substance: cyclophosphamide (CPA)
Route of administration: Oral gavage
Doses: 64 mg/kg bw
Dosing volume: 10 mL/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow, Polychromatic erythrocytes (PCEs)
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Preliminary toxicity testing
DETAILS OF SLIDE PREPARATION: The animals were sacrificed by CO2 asphyxiation. Bone marrow was harvested in fetal calf serum from the shafts of both femurs, centrifuged and resuspended in fetal calf serum. Smears prepared from this suspension were stained with May-Grunwald/Giemsa solution and mounted.
METHOD OF ANALYSIS: The slides of five animals/sex/dose, showing good differentiation between mature and polychromatic erythrocytes, were scored by a laboratory technician. The incidence of micronucleated polychromatic erythrocytes (MNPCE) among at least 2000 polychromatic erythrocytes (PCE) and the ratio of PCE to normochromatic erythrocytes (NCE) among a total of at least 1000 erythrocytes were determined for each slide. - Evaluation criteria:
- Please, see "Any other information on results incl. tables" section
- Statistics:
- The significance of differences between control and treated groups was assessed by the Chi-Squared-Contingency-Test (F=1, p<0.05).
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- the high dose group
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
In the first step of the tolerability test, the dose of 2000 mg/kg of the test substance, was administered to one female and one male animal. One to two hours after dosing, both mice exhibited recumbence and died within two to three hours after administration. In the second step, a pair of mice was treated with 800 mg/kg of the test substance. Both animals exhibited recumbence and decreased muscle tone. They were found dead three hours after dosing. In the third step, one female and one male were dosed with 320 mg/kg of the test substance. No symptoms of toxicity occurred during the three days observation period . In the confirmatory step, again one male and one female received 320 mg/kg of the test substance. No symptoms of toxicity were observed. Based on these results, the dose of 320 mg/kg for females and males was chosen as the highest one to be administered in the micronucleus test.
RESULTS OF DEFINITIVE STUDY
- In the high dose group (24 hours sampling time), two female and four male animals exhibited creeping movements, recumbence and decreased muscle tone on day of sacrifice. No symptoms of toxicity were noted in the intermediate and low dose groups.
- In the group of 48 hours sampling time dosed with 320 mg/kg test substance, one female and one male showed creeping movements, recumbence and decreased muscle tone on day of sacrifice. One male was found dead on day of sacrifice and was replaced by a reserve animal. No symptoms of toxicity occurred in the other animals.
- At both sampling times (24 and 48 hours) there was no statistically significant increase in the number of micronucleated polychromatic erythrocytes in the animals treated with the respective doses of the test substance, as compared with the negative control animals.
- At the 24 hours sampling time after treatment with the test substance the mean percentage of micronucleated PCEs was 0.07 (80 mg/kg), 0.10 (160 mg/kg) and 0.08 (320 mg/kg ) respectively compared to a negative control value of 0.08.
- At the 48 hours sampling time after treatment with 320 mg/kg of the test substance the mean percentage of micronucleated PCEs was 0.12 compared to a negative control value of 0.10
- In the positive control (24 hours) the percentage of micronucleated cells within polychromatic erythrocytes was significantly increased. The mean percentage of micronucleated PCEs evaluated was 1.80. In comparison with the negative control of 0.08% this value is highly significant (p<0.05).
Any other information on results incl. tables
Table 1. Overall mean percentage of micronucleated PCEs
Treatment time |
320 mg/kg |
160 mg/kg |
80 mg/kg |
Positive control |
Negative control |
24 hours |
0.08 |
0.10 |
0.07 |
1.80 |
0.08 |
48 hours |
0.12 |
|
|
|
0.10 |
Analytical results
The test material in suspension was analysed by HPLC with UV detection to confirm the intended concentrations to be used in the micronucleus test and the stability of the test substance in the vehicle used.
Nominal concentrations |
Actual concentrations |
||
Experiment |
pg/mL |
pg/mL |
% of nominal value* |
24 + 48 h |
64000 |
62250/62899 |
97.3/98.3 |
24 h |
16000 |
18700/18804 |
117/118 |
* acceptable range: 100 ± 20 %
The values found by analysis of all samples were in agreement with the intended concentrations, demonstrating sufficient stability of the test substance in the vehicle.
Applicant's summary and conclusion
- Conclusions:
- In a mouse bone marrow micronucleus assay performed in compliance with GLP and following an OECD 474 guideline, there was no significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow after any treatment time. There was no evidence for clastogenic or aneugenic effects in mice treated with the test substance.
- Executive summary:
In a mouse bone marrow micronucleus assay performed in compliance with GLP and following an OECD 474 guideline, groups of 5 male and 5 female young adult, Ico:CD1 [CRL] mice were dosed orally, by gavage, with the test substance at doses of 0, 0, 80, 160, 320 and 320 mg/kg/day. An additional group was dosed with the positive control, cyclophosphamide at 64 mg/kg/day. One group of mice at each test substance dose level, plus one negative control group and the positive control group were killed after 24 hours. The other negative control group and 320 mg/kg/day group were killed after 48 hours. Femoral bone marrow cells were harvested and polychromatic erythrocytes scored for micronuclei.
In the 320 mg/kg dosage group (24 hours sampling time), four males and two females exhibited creeping movement, recumbence and decreased muscle tone the day after administration. No symptoms of toxicity were noted in the 160 and 80 mg/kg groups. In the 320 mg/kg group (48 hours sampling time) one male was found dead two days after administration and was replaced by a reserve animal. Creeping movement, recumbence and decreased muscle tone were occasionally observed shortly before sacrifice. In the reserve group one female was found dead two days after administration. No statistically significant increase in the number of micronucleated polychromatic erythrocytes was observed in any group when compared with the respective negative control group. The positive control induced the appropriate response.
There was no significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow after any treatment time. There was no evidence for clastogenic or aneugenic effects in mice treated with the test substance.
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