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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study, comparable to guideline study with acceptable restrictions (purity of test substance not indicated)
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Reference Type:
- publication
- Title:
- Teratology studies on benzothiazolesulfenamides
- Author:
- Stevens M., W.
- Year:
- 1 982
- Bibliographic source:
- Toxicologist, 2, 73
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- 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:
- Santocure NS
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- M/F ratio per cage: 1:1
- Duration of treatment / exposure:
- days 6-15 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- days 6 tot 20 of gestation
- No. of animals per sex per dose:
- 25 animals per dose
- Control animals:
- yes
- Details on study design:
- Sex: female
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 500 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 500 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Clinical signs and mortality: No mortality occured in any of the treated animals 50 and 150 mg/kg bw/d: no biologically meaningfuldifferences in appearance or behavior in rats when compared to the control group Matting of the ventral or anogenital haircoat was noted in all four dosage groups with the greatest incidence occuring in rats in the 500 mg/kg bw/d dose group (4, 1, 2 and 10 respectively).A post-dose response of reduced activity was noted in two of these 10 rats of the highest dose group on gestation day 6 and 7. Incidentalfindings of hair loss and/or red matter on the nasal region were noted on several rats in the treated groups as well as the control group at various times during gestation
Necropsy observations at Cesarean section
control: 1/25 hydrometra
150 mg/kg bw/d: 1/25 ovarian cyst
500 mg/kg bw/d: 1/25 fibrinous pleuritis and congested lungs, 1/25 hydrometra, 1/25 ovarian cyst
Body weights
50 and 150 mg/kg bw/d: no biologically relevant differences compared to control 500 mg/kg bw/d: very slight decrease in mean maternal body weight gain (ca. 1 -2 %) during the treatment period. however, no differences were noted in comparing the corrected gestation day 20 body weights (gestation day 20 body weight minus uterus weight) of the treated groups to the control group
Cesarean section observations
50, 150, 500 mg/kg bw/d:no biologically meaningful or statistically significant differences in the mean numbers of postimplantation loss, early resorptions, mean fetal body weight or fetal sex distribution compared to control Slight decrease were noted in the mean numbers of corpora lutea (4 %, 1%, 4 % at 50, 150 and 500 mg/kg bw/d, respectively)and total implantations in all three treatment groups (7 %, 6% amd 8 % at 50, 150 and 500 mg/kg bw/d). These decreases were attributed to random occurence as ovulation and implantation occur prior to treatment. A corresponding decrease in the mean numbers of viable fetuses in these groups was not considered biologically meaningful as the values were comparable to the historical control value.
Fetal morphological observations: 50, 150 and 500 mg/kg bw/d: no biologically meaningful differences in the total numbers of fetuses or litters with malformations compared to control A slight increase in the number of litters and fetuses with undeveloped renal papillae and/or distended ureters was noted in the three treated groups but was not considered biologically meaninful since this increase was within the range estabished in the historical control data. Renal papillae not developed and/or distended ureters:
control: fetuses: 3(1.7%), litters: 2( 8.3 %)
50 mg/kg bw/d:fetuses: 7(4.6 %), litters: 5( 22.7 %)
150 mg/kg bw/d:fetuses: 8(5.1 %), litters: 5( 21.7 %)
500 mg/kg bw/d:fetuses: 7(4.8 %), litters: 6( 27.3 %)
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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