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EC number: 407-430-1 | CAS number: 3741-80-8 CP22595; SANTOCURE TBS1
- 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:
- screening for reproductive / developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study, basic data given (abstract and tables)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 997
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)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- N-tert-butylbenzothiazole-2-sulphenamide
- EC Number:
- 202-409-1
- EC Name:
- N-tert-butylbenzothiazole-2-sulphenamide
- Cas Number:
- 95-31-8
- Molecular formula:
- C11H14N2S2
- IUPAC Name:
- N-tert-butylbenzothiazole-2-sulphenamide
- Details on test material:
- purity 96.4%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 5% gum arabic
- Details on mating procedure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Males 42 days, females 38 days (from 14 days prior to mating to day 3 of lactation)
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 40, 200, 1000 mg/kg bw and day
Basis:
- No. of animals per sex per dose:
- 13 per dose and sex
- Control animals:
- yes
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 40 mg/kg bw/day
- Sex:
- female
- Basis for effect level:
- other: no effects
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 200 mg/kg bw/day
- Sex:
- female
- Basis for effect level:
- other: slight histopathological changes in kidney and in the liver
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 000 mg/kg bw/day
- Sex:
- female
- Basis for effect level:
- other: no biologically relevant effects
- Remarks on result:
- other: Generation: fertility
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- other: no further infomation available
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Maternal toxicity:
40 mg/kg bw and day
no effects
200 mg/kg bw and day
temporary salivation after each administration at autopsy on postpartum day 4, slight vacuolar degeneration in the proximal tubules of kidney was observed slight increase in the relative kidney weights slight hypertrophy of hepatocytes in the central zone
1000 mg/kg bw and day
temporary salivation after each administration food consumption was decreased prior mating and along with slight suppressiomn of body weight gain during pregnancy at autopsy on postpartum day 4, slight vacuolar degeneration in the proximal tubules of kidney was observed slight increase in the relative kidney weights slight hypertrophy of hepatocytes in the central zone increase in relative liver weights deposition of brown pigment in the spleen (tended to increase but in many cases comparable to control group)
Fertility:
40 mg/kg bw/d:
No effects on copulation and ovulation, no dose-related abnormalities with regard to parturition and lactation Fertility index was lower than control level; however the low index observed seemed to be an accidental finding because all females in the
200 mg/kg bw/d group were found to be fertile, thus the authors concluded that this decreased is not biologically relevant
200 mg/kg bw/d:
No effects on copulation and ovulation, no dose-related abnormalities with regard to parturition and lactation no effects on fertility index
1000 mg/kg bw/d: No effects on copulation and ovulation, no dose-related abnormalities with regard to parturition and lactation Fertility indice was lower than control level, however, the relvance of this finding is questionable. This decrease was not reflected by other fertility parameter like the number of corpora lutea, number of implantation sites and implantation index (see table). The values noted at 1000 mg/kg bw and day were all within the variation range of the current negative control and were not statistically significant. Moreover, the decrease of the fertility index noted was not dose-dependent. No test substance-related adverse effects on the reproductive organs were indicated in the 90 day toxicity study (Monsanto Co 1985). Fetal: No adverse effects on viability, the sex ratio and body weights of pups in any of the treated animals. TBBS at the dose levels applied did not demonstrate teratogenicity
Summary of reproductive performance in parental rats
Applicant's summary and conclusion
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