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EC number: - | CAS number: 75045-07-7
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: secondary literature - cited from OECD SIDS and US EPA
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- In a combined, repeated-dose reproductive/developmental toxicity study, Sprague-Dawley rats (10/sex/dose) were administered CASRN 61617-00-3 orally in the diet at 1000, 2750 or 7500 ppm (~ 50, 138 or 375 mg/kg-bw/day). Treatment began two weeks prior to mating and continued throughout gestation, up to postnatal day 5 (~ 47 days). Doses were reduced to 900, 2500 or 6750 ppm on day 29 (~ 45, 125 or 338 mg/kg-bw/day) and on day 33, the high-dose group was further reduced to 5500 ppm (~ 275 mg/kg-bw/day) due to observed toxicity (type not specified in robust summary).
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione, zinc salt
- EC Number:
- 262-872-0
- EC Name:
- 1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione, zinc salt
- Cas Number:
- 61617-00-3
- Molecular formula:
- C8H8N2S.1/2Zn
- IUPAC Name:
- Zinc bis[4(or 5)-methyl-2-thioxo-2,3-dihydrobenzimidazol-1-ide]
- Details on test material:
- methyl-2-mercaptobenzimidazole, zinc salt = Vanox ZMTI; purity 99.9%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Details on mating procedure:
- Following 2 weeks of dosing, male and female rats were paired within their dose groups to produce litters
- Duration of treatment / exposure:
- Treatment began 2 weeks prior to mating and continued throughout gestation, up to postnatal day 5 (ca. 47 days)
- Frequency of treatment:
- daily
- Details on study schedule:
- At day 5 post partum, all surviving females, males and offpring were killed and examined macroscopically
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1000, 2750 or 7500 ppm (ca. 50, 138 or 375 mg/kg bw/day) day 1-28
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
900, 2500 or 6750 ppm (ca. 45, 125 or 338 mg/kg bw/d) day 29-32
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
high dose group was further reduced to 5500 ppm (ca. 275 mg/kg bw/d) day 33-45
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 45 - 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: based on increased gestation lenght
- Dose descriptor:
- NOAEL
- Effect level:
- 275 - 338 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: based on no effects observed at the highest dose tested
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
The combined repeated-dose reproductive/developmental toxicity study showed both systemic and reproductive toxicity in orally exposed rats. Significant decrements in body weight gain and organ weights were observed at all levels of treatment, including the lowest dose tested (45-50 mg/kg/day). Female reproductive toxicity, as evidenced by increased gestation length, occurred at all doses. The NOAEL for male reproductive toxicity was approximately 275-338 mg/kg/day, based on no effects at the highest dose tested. Developmental toxicity could not be evaluated due to a high incidence of mortality in the dams.
Applicant's summary and conclusion
- Executive summary:
The administration of Vanox ZMTI to male and female rats at dose levels of up to 7500 ppm (~ 375 mg/kg bw/d) (adjusted to 6750 ppm (~ 338 mg/kg bw/d and then to 5500ppm (~ 275 mg/kg bw/d)) for a period of up to forty seven days; which included a mating period, gestation and early lactation phase, resulted in treatment-related upon mating performance, fertility and the parturition process. The "No Observed Adverse Effect Level" (NOAEL) for reproductive effects upon adults was not established.
The LOAEL for systemic toxicity = 45 -50 mg/kg bw/d.
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