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EC number: 205-286-2 | CAS number: 137-26-8
- 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: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 Oct 1990 - 29 Jan 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 484 (Genetic Toxicology: Mouse Spot Test)
- Version / remarks:
- adopted in 1986
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.24 (Mouse Spot Test)
- Deviations:
- yes
- Remarks:
- consecutively to negative results, statsitical analysis was not performed
- GLP compliance:
- yes
- Type of assay:
- mouse spot test
Test material
- Reference substance name:
- Thiram
- EC Number:
- 205-286-2
- EC Name:
- Thiram
- Cas Number:
- 137-26-8
- Molecular formula:
- C6H12N2S4
- IUPAC Name:
- thiram
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: NMRI (female), DBA/2 (male)
- Details on species / strain selection:
- The mouse is the most suitable species with strains expressing coat colour mutations which are well characterized with regard to the genetic background.
In addition, the mouse is an experimental animal in many physiological , pharmacological, and toxicological studies. Data from such experiments also may be useful for the design and the performance of the mouse spot test. - Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Laboratory for Mutagenicity Testing, Darmstadt, Germany (females), BRL- Tierfarm Füllinsdorf, Germany (males)
- Age at study initiation: minimum 10 weeks
- Weight at study initiation: approx. 30 g
- Housing: individually after treatment in Makrolon Type II cages with wire mesh top
- Diet: pelleted standard diet (ALTROMIN, Lage/Lippe, Germany)
- Water: tap water, ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 20 -80
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 4 Oct 1990 To: 29 Jan 1991
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose); 1%
- Justification for choice of solvent/vehicle: toxicity profile in animals - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The dose was adjusted to the most recent body weight.
- Duration of treatment / exposure:
- single oral dose at Day 9 of pregnancy
- Frequency of treatment:
- single oral dose
- Post exposure period:
- 3 weeks. Offspring was examined between day 39-43 after birth. For a detailed study schedule, please refer to "Any other information on materials and methods incl. tables".
Doses / concentrationsopen allclose all
- Dose / conc.:
- 75 mg/kg bw/day
- Dose / conc.:
- 750 mg/kg bw/day
- No. of animals per sex per dose:
- Treated animals were:
Solvent control: 21 pregnant females
Positive control: 30 pregnant females
75 mg/kg bw: 29 pregnant females
750 mg/kg bw: 79 pregnant females - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Ethylnitrosurea (ENU)
- Route of administration: orally, once
- Doses / concentrations: 20 mg/kg bw
- Volume: 10 mL/kg bw
- Solvent: physiological saline, pH 4.5
- The solution was prepared on the day of administration.
Examinations
- Tissues and cell types examined:
- The offspring were coded and scored for the occurrence of pigmented spots.
Three classes of spots were distinguished:
1. WMVS (white mid-ventral spots);
White spots within 5 mm of the mid-ventral line which are presumed to result from cell killing.
2. MDS (misdifferentiation spots):
Yellow, agouti-like spots associated with mammaet genital ia, throat, axillary and inguinal areas and mid-forehead, which are presumed to result from misdifferentiation.
3. RS (recessive spots) :
pigmented and white spots randomly distributed on the coat which are presumed to result from somatic mutation.
All three classes of spots were scored but only the last, RS, is of genetic relevance. Microscopic analysis of mounted coloured hairs was performed only if there were doubts in classification of a spot. - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: A pre-experiment with 750 mg/kg bw was conducted.
- Evaluation criteria:
- The test article is classified as mutagenic if it induces a statistically significant dose-related increase in the frequency of genetically relevant spots or a statistically significant positive response for at least one of the test points compared with the negative control.
The test article is classified as non-mutagenic if it induces no statistically significant dose-related increase in the frequency of genetical ly relevant spots and no statistically significant positive response for at least one of the test points compared with the negative control.
Both biological and statistical significance should be considered together in the evaluation. - Statistics:
- A statistical analysis of the results was not necessary to perform as after treatment with the test article the frequency of recessive spots which are presumed to result from somatic mutation were in the range of the negative control value.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- 750 mg/kg bw = MTD
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 750 mg/kg bw
- Results: A pre-experiment was realised in order to evaluate the toxicity of the test susbtance. After a single oral dose of 750 mg/kg bw, the treated animals expressed toxic reactions (reduction of spontaneous activity, ptosis, apathy); this dose was estimated to be the MTD.
RESULTS OF DEFINITIVE STUDY
In the mutation assay the mean litter size was not reduced after treatment with the test article indicating no embryotoxic effects. Experimental conditions as well as criteria for the determination of test responses are well defined and appropriate. Controls gave the expected response. In the vehicle test group one recessive spot (RS) was observed. After treatment with 75 or 750 mg/kg bw thiram, the frequency of RS was 0.75 and 0.62%, respectively, which are in the range of the historical control data (0.00%- 1.00%). The positive control showed a distinct increase in induced RS frequency.
Summarized results can be found in Attachment 1 in the attached background material.
Applicant's summary and conclusion
- Conclusions:
- The study was conducted according to the OECD guideline 484 and under GLP conditions. During the mutagenicity assay described and under the experimental conditions reported, the test article did not induce mutations in somatic cells of the mouse.
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