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EC number: 225-625-8 | CAS number: 4979-32-2
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 1988 - April 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline study conducted to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- no ophthalmological examinations performed
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- N,N-dicyclohexylbenzothiazole-2-sulphenamide
- EC Number:
- 225-625-8
- EC Name:
- N,N-dicyclohexylbenzothiazole-2-sulphenamide
- Cas Number:
- 4979-32-2
- Molecular formula:
- C19H26N2S2
- IUPAC Name:
- N-(1,3-benzothiazol-2-ylsulfanyl)-N-cyclohexylcyclohexanamine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratory, Portage MI
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: approx 6 weeks
- Weight at study initiation: males: 213.1-240.7g, females: 151.7-170.4
- Fasting period before study: not specified
- Housing: individual stainless steel cages
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib (St. Louis public water supply)
- Acclimation period: not specified
DETAILS OF FOOD AND WATER QUALITY:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70-64˚F
- Humidity (%): 30-60%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified
IN-LIFE DATES: animal arrival 31 May 1988
Administration / exposure
- Route of administration:
- oral: feed
- Details on route of administration:
- Basal Diet: Purina Mills Certified RODENT CHOW #5002
Frequency of Preparation: Approximately weekly
Levels Prepared: T-3 (5000 ppm), T-2 (2500 ppm), T-1 (500 ppm)
Mixing Machine: HOBART HCM-450
Mixing Time: 10 minutes
Batch size: Premix (also used as T-3), 14.6 kilograms; other levels,
9 kgs each.
Mixing Procedure Number: DP-88121-1 - Vehicle:
- other: DCBS contained in the diet
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Test material stability: liquid chromotography using variable wavelength UV/VIS detector.
Homogeneity of Diet Mixtures: Analysis of duplicate samples from top, middle, and bottom of mixer of T-1 and T-3 levels.
Diet Mixture Stability: Analysis of T-1 and T-3 level samples kept frozen (closed container, days) or at ambient temperature (open container, 7 and 14 days).
Dietary Level Verification: Extraction of
SANTOCURE DCBS with 90/10 hexane/methylene chloride, analysis by liquid chromotography using variable wavelength UV/VIS detector; all dietary levels for first 7 weeks, thereafter at least once/week. - Duration of treatment / exposure:
- 3 months
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Remarks:
- control
- Dose / conc.:
- 500 ppm
- Remarks:
- 500 ppm (ca. 36.9 mg/kg bw/d)
- Dose / conc.:
- 2 500 ppm
- Remarks:
- 2500 ppm (ca. 176.7 mg/kg bw/d)
- Dose / conc.:
- 5 000 ppm
- Remarks:
- 5000 ppm (ca. 342.6 mg/kg bw/d)
- No. of animals per sex per dose:
- 15 per dose and sex
- Control animals:
- yes, plain diet
- Details on study design:
- Post-exposure period: no data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
- Cage side observations for moribundity and mortality.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once weekly
BODY WEIGHT: Yes
- Time schedule for examinations: once weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): yes, once weekly
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes - see 'any other information on materials and methods'
CLINICAL CHEMISTRY: Yes - see 'any other information on materials and methods'
PLASMA/SERUM HORMONES/LIPIDS: No
URINALYSIS: Yes - see 'any other information on materials and methods'
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: see 'any other information on materials and methods' - Statistics:
- Dunnett’s Multiple Comparison Test (two-tailed) (1): Body weights and food consumption.
Fisher’s Exact Test (2) with Bonferroni Inequality Procedure (4): Incidence of microscopic lesions.
Terminal body weights, absolute organ weights, organ/body weight ratios and selected noncategorical clinical pathology data were evaluated by decision-tree statistical analysis procedures which, depending on the results of tests for normality (3) and homogeneity of variances (Bartlett’s Test), chose either the parametric (Dunnett’s Test and Linear Regression) or nonparametric (Kruskal-Wallis, Jonckheere’s and/or Mann-Whitney Tests) routines to detect group differences and analyzed for trend.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- there were no clinical signs considered to be related to treatment.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Male and females of the two highest dietary levels had reduced weight gains throughout the study (compared to control: males 2600 ppm:-6.4 %, 5200 ppm:-9 %, females 2600 ppm -10.0%, 5200 ppm: -15.6%. Lowest dietary level males and females were not significant different from control (males 540 ppm 0.3 %, females 540 ppm: -1.8 %). See table 'body weight'.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- slight decrease in food intake at the two highest exposure levels (2600, 5200 ppm, males: -10.5%, -12.4%, females: -9.7%, -20.5%. The lowest food intake values occurred during the first week of exposure, and the animals gradually began to approach control group feeding levels during the remainder of the study. Animals from the 540 ppm group consumed similar food as compared to control (males: -3.7%, females: -0.6%). See table 'food consumption'.
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- there were no relevant changes in hematologic parameters at either sampling period
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Mean glucose values were slightly to moderate decreased in males of the highest dose group (period 1), in males of the 2600 ppm group (period 2) and in all treated females(period 2). These changes may have been related to treatment; however the male 5200 ppm group (period 1) was largely affected by a low value in one animal. The apparent decrease in values for treated females at period 2 (compared to the control group values) was a function of the slightly higher than expected control group values, and therefore was considered to be of equivocal biological significance.
Inorganic phosphorus values were slightly increased in males of the highest dose groups (2600, 5200 ppm) and in females of the highest dose group. Total protein and albumin values were slightly decreased for females of the 540 and 2600 ppm groups (period 2), and globulin was slightly decreased in all treated females groups. The mean potassium value for the males of the highest dose group (period 1) was slightly increased. All of these changes were either of small magnitude, inconsistent between periods or sex, or not related to dose and therefore were considered equivocal in their relationship to treatment. - Endocrine findings:
- not examined
- Urinalysis findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The only statistically significant absolute organ weight change observed was a slight decrease in absolute heart weights probably resulted from the decreased mean body weight in this group; in addition no biologically relevant change in organ/body weight ratios
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- no significant gross necropsy changes noted at sacrifice.
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- there were no microscopic changes attributable to administration of the test substance
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 36.9 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects
- Dose descriptor:
- LOAEL
- Effect level:
- 176.7 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Slight decrease in body weight gain compared to control (males -6.4%, females -10%)
Target system / organ toxicity
- Critical effects observed:
- no
Any other information on results incl. tables
Analysis of test material and diets:
Results of analyses for neat compound stability conducted over the span of time approximately equal to the study length, indicated the test material was stable. The homogeneity and stability of the diet mixtures was determined to be adequate for study use. The following table shows the overall averages (uncorrected for quality control results):
Test Group: | T1 | T2 | T3 |
Target exposure (ppm): | 500 | 2500 | 5000 |
Study mean concentration (ppm): | 540 | 2600 | 5200 |
St. Deviation (ppm): | 11 | 71 | 130 |
% difference from target: | 8.0 | 4.0 | 4.0 |
Body weight:
Group | Study Mean | % diff. from control (study mean) | % diff. from control (final bw) | % gain from initial |
MN | 417.8 | - | - | 132.9 |
M1 | 419.0 | 0.3 | 0.1 | 133.4 |
M2 | 391.1 | -6.4 | -8.1 | 114.8 |
M3 | 380.2 | -9.0 | -9.3 | 111.4 |
FN | 236.2 | - | - | 73.8 |
F1 | 232.0 | -1.8 | -3.7 | 67.1 |
F2 | 212.5 | -10.0 | -12.9 | 51.0 |
F3 | 199.4 | -15.6 | -20.1 | 38.7 |
Food Consumption:
Group | Study Mean | % diff. from control (study mean) |
MN | 26.7 | - |
M1 | 25.7 | -3.7 |
M2 | 23.9 | -10.5 |
M3 | 23.4 | -12.4 |
FN | 17.6 | - |
F1 | 17.5 | -0.6 |
F2 | 15.9 | -9.7 |
F3 | 14.0 | -20.5 |
Applicant's summary and conclusion
- Conclusions:
- The authors concluded that the No Observed effect level (NOEL) for this study is 500 ppm (36.9 mg/kg bw/day) (Monsanto 1989).
The LOAEL for the study can be concluded as 176.7 mg/kg bw/d (2500ppm) based on the noted effects on body weight and food consumption in male and female animals. - Executive summary:
Study outline
In a 90 day feeding study according to OECD 408, DCBS was administered to male and female Sprague-Dawley rats at target levels of 0, 540 ppm, 2600 ppm and 5400 ppm (study mean concentrations) in the diet (corresponding to mean compound consumption of 0, 36.9, 176.7 and 342.6 mg/kg bw/day).Results
Analysis to verify the stability of the test material both neat and when mixed wiuth the diet, the diet homogeneity and concentrations of the test material in diet were undertaken with satisfactory results. Overall averages of dietary concentrations were found to be 540, 2,600 and 5,200 ppm.
Both sexes at the two highest exposure levels had reduced food consumption (males: -10.5 %, -12.4 %, and females: -9.7 %, -20.5 %) and reduced body weight gain compared to control (males:-6.4 %, -9 %, and females -10.0 %, -15.6 %). The lowest food intake values occurred during the first week of exposure, and the animals gradually began to approach control group feeding levels during the remainder of the study. The authors suggest that this pattern in food consumption after the initial exposure reveal that the animals acclimated themselves to the treated diets. However, the lower weight gain appeared to have resulted from decreased food intake, rather than a direct toxic response to the test chemical. This interpretation was supported by the absence of any significant clinical, gross or microscopic pathologic findings.
Changes seen in some serum chemistry parameters (especially decreased glucose) and organ weights or their ratios may have resulted from the lower food intake and/ or the lower body weight.
Conclusions
The authors concluded that the No Observed effect level (NOEL) for this study is 500 ppm (36.9 mg/kg bw/day) (Monsanto 1989).
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