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EC number: 246-896-9 | CAS number: 25360-10-5
- 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: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- 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 that meets generally accepted scientific standards, well documented and acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- Deviations:
- yes
- Remarks:
- 2 dose levels, limited haematology, blood chemistry and microscopic examination
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- tert-dodecanethiol (CAS # 25103-58-6)
- IUPAC Name:
- tert-dodecanethiol (CAS # 25103-58-6)
- Details on test material:
- Supplier: Phillips Petroleum Company
Test article name: Mercaptan mixture aliphatic, Sulfole 120
Batch : batch no. 444
Purity: no data
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 Laboratories, Inc., Portage, MI, USA
- Age at study initiation: 49 days of age
- Weight at study initiation: 252-270 g for males, 162-172 g for females
- Fasting period before study: no
- Housing: individually
- Diet (ad libitum excepted during exposure): Purina certified roden chow #5002
- Water (ad libitum): tap water
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
As per "Guide for the care and Use of Laboratory animals" (DHEW No. NIH 74-23, 1974)
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- clean air
- Remarks on MMAD:
- MMAD / GSD: at 100 ppm:
Equivalent aerodynamic diameter (µm) 2.7 +/- 1.64 on week 3 and 3.6 +/- 1.64 on week 5 - Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 16 m3 stainless steel and glass chamber
- Method of holding animals in test chamber: individually in suspended stainless steel wire-mesh cages
- Source and rate of air: HVAC system, 2000 L/min
- Method of conditioning air: the air was filtered and the temperature and relative humidity were controlled
- System of generating particulates/aerosols: counter-current vaporization system
- Temperature, humidity, pressure in air chamber: 72-76 °F, 47-57%
- Air flow rate: 2000 L/min
- Air change rate: no data
- Method of particle size determination: Andersen cascade impactor for the 100 ppm group and GC analysis
- Treatment of exhaust air:
TEST ATMOSPHERE
- Brief description of analytical method used: drawing samples of the test atmospheres through sorbent tubes containing XAD-4 resin and analysis with a gas chromatograph equipped with a flame photometric detector
- Samples taken from breathing zone: yes - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The actual concentrations of test material were determined by gas chromatograph (GC) each exposure day. Nominal concentrations were also calculated for all exposures. Aerosol particle size determinations were conducted after two and four weeks of exposure for those groups where a significant amount of aerosol was present.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 6 hours/day; 5 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
25 and 100 ppm
Basis:
other: Desired conc.
- Remarks:
- Doses / Concentrations:
26 ppm and 98 ppm
Basis:
analytical conc.
- Remarks:
- Doses / Concentrations:
42 and 214 ppm
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, sham-exposed
- Details on study design:
- - Rationale for animal assignment (if not random): Computerized selection using homogeneity of body weight variances as the criterion for acceptance.
- Dose selection rationale: no data
- Post-exposure recovery period in satellite groups: none
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: All animals were observed for mortality twice daily.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Detailed observations were conducted weekly.
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes, weekly
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: after 4 weeks of exposure
- Anaesthetic used for blood collection: Yes (identity) / No / No data
- Animals fasted: Yes
- How many animals: all
- Parameters: Hematocrit, hemoglobin concentration, erythrocyte count, mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCHC), leukocyte count (total and differential).
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: after 4 weeks of exposure
- Animals fasted: Yes
- How many animals: all
- Parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, glucose, urea nitrogen, and creatinine.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes , All surviving animals after 4 weeks.
ORGAN WEIGHTS: heart, lungs and trachea, liver, testis, kidney, brain and ovary.
HISTOPATHOLOGY: Yes
Microscopic examination of formalin-fixed hematoxylin-eosin stained paraffin sections from all animals: adrenal (2), liver (2 lobes), kidney, heart, gonad, lungs (all lobes), trachea (distal and bifurcation), brain and all gross lesions. - Statistics:
- Analysis of body weights, clinical laboratory tests and organ weights (absolute and relative both to body and brain weight) will be performed using the methods indicated below.
Parametric analysis was conducted utilizing Bartlett's Chi-Square test for homogeneity of variance followed, where appropriate, by an analysis of variance and then, where appropriate, by Dunnett's -t test. In cases where the data were more amendable to analysis by non-parametric methods, the Conover & Iman Tank transformation method was used. In all cases the level of rejection was at the five (5) percent level.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Essentially no signs were observed in the rats for the first three weeks of the study. The only apparently test material-related sign in the rats was the presence of material (described as dark, red or black) around the nose and eyes which was seen more often in the 100 ppm Group animals than in the control and 25 ppm Groups. This sign was observed with significant incidence (3/10 males, 6/10 females) only during week 4.
BODY WEIGHT AND WEIGHT GAIN
The mean body weight for the 100 ppm Group male rats was significantly reduced below that of the controls at weeks 2, 3 and 4. The mean body weights of the female rats from 100 ppm Group tended to be decreased at all weeks, but the differences were not statistically significant.
FOOD CONSUMPTION
Expressed as g/animal/day, the food.consumption of the high level-exposed rats (100 ppm) was significantly decreased below control values of weeks 1, 2 and 3 in the males and weeks 2 and 3 in the females. The values for the 100 ppm Group rats of both sexes also averaged less than the control values at the other weeks of the study, but the differences were not statistically significant. Expressed on a g/kg/day basis, food consumption of the 100 ppm Group animals (male or female) was significantly decreased below control values at weeks 1 and 2, but not 3 and 4.
HAEMATOLOGY
There were no noteworthy haematology differences in the rats.
CLINICAL CHEMISTRY
There were no serum biochemical changes in the rats that were considered to be exposure related. The one statistically significant change (increased creatinine level in the 100 ppm Group males) was considered to be anomalous as the value was written the normal range for male rats of this age.
ORGAN WEIGHTS
Test material exposure-related increases in liver weight were noted at 100 ppm. Since there were no correlative macro- or microscopie liver changes, the increased liver weights in rats cannot be clearly related to the test material exposures.
GROSS PATHOLOGY
There were no clear test article related macroscopic changes observed among rats exposed to either 25 or 100 ppm. An increased incidence of urinary obstruction was observed in females exposed to 100 ppm. The changes were characterized by distention of the ureter and hydronephrosis. There were no calculi reported in either the bladder or the ureter and the bladder was free of other macroscopic changes.
HISTOPATHOLOGY: NON-NEOPLASTIC
Test article related microscopic renal tubular degeneration with regeneration and granular casts were observed in males at both 25 and 100 ppm. The lungs were free of test-article related changes. Hydronephrosis (4 examined) with distention of the ureter(s) (3 examined) was observed in females exposed to 100 ppm. There were no macroscopic calculi observed in either the ureter or the bladder. There were no macroscopic changes in the bladder which therefore remained unexamined microscopically as directed by protocol. The significance of this common spontaneous finding was unclear.
A description of the pertinent findings can be seen below:
Tubular Degeneration:
- Vacuolation and sloughing of tubular epithelial cells primarily in the proximal tubules.
Granular Cast:
- Granular cellular debris occluding the lumen of tubules, usually at the junction of the distal end of the proximal tubule and the beginning of the thin segment of the loop of Henle located near the junction of the inner and outer cortex.
Tubular Regeneration:
- The presence of regenerating epithelium in renal tubules characterized by small basophilie cells with a high nuclear to cytoplasmic ratio. Frequently seen subsequent to tubular degeneration.
The tubular degeneration and regeneration and granular casts seen in male rats exposed to TDM were consistent with "Hydrocarbon Nephropathy". The changes were of trace to mild severity and were invisible macroscopically. However, creatinine was increased significantly in male rats at 100 ppm TDM. Hydronephrosis, observed in females, has been a common spontaneous genetic condition often related to partial obstruction of the ureter(s) either with calculi or by some other more subtle process. In the absence of microscopic examination of the bladder this finding could not be dismissed.
Pertinent but incidental microscopic findings were observed in the lungs and liver. A spontaneous acute pulmonary periarteritis was present in both sexes and in all groups, control and experimental. It was considered to be consistent with an early inflammatory response to viral infection. "Liver masses" and "foci" described macroscopically were focal areas of cell disassociation caused by inadvertent intrahepatic injection of sodium pentobarbital during euthanasia.
Additional microscopic changes were observed in a variety of organs. They were considered to be incidental and usual for rats of this strain and age.
Effect levels
- Dose descriptor:
- LOAEC
- Effect level:
- 26 ppm (analytical)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: = 215 mg/m3. Kidney changes in female rats.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1: PERTINENT ORGAN WEIGHT CHANGES - RATS
Sex |
Males |
Females |
||||
Group |
Control |
25 ppm |
100 ppm |
Control |
25 ppm |
100 ppm |
Body Weight (g) |
331 |
327 |
305 |
207 |
206 |
192 |
Brain Weight (g) |
1.91 |
1.95 |
(1.82) |
1.82 |
1.77 |
(1.72) |
Brain/Body Weight (%) |
5.82 |
6.02 |
6.00 |
8.83 |
8.64 |
9.03 |
Liver (g) |
12.83 |
13.01 |
14.34 |
8.59 |
9.15 |
[10.81] |
Liver/Body Weight (%) |
3.88 |
3.97 |
[4.69] |
4.15 |
4.44 |
[5.60] |
Liver/Brain Weight (% x 10-2) |
6.72 |
6.66 |
(7.89) |
4.74 |
5.16 |
[6.30] |
( )statistically significant p<0.05
[ ] = statistically significant p<0.01
There were no correlative microscopie findings.
Table 2: PERTINENT MICROSCOPIC CHANGES - RATS
Sex |
Males |
Females |
||||
Group |
Control |
25 ppm |
100 ppm |
Control |
25 ppm |
100 ppm |
NUMBER EXAMINED |
10 |
10 |
10 |
10 |
10 |
10 |
KIDNEY |
||||||
Tubular degeneration and regeneration |
1 |
5 |
||||
Granular casts |
4 |
|||||
Hydronephrosis |
1 |
1 |
4 |
|||
URETER |
||||||
Dilatation |
3 |
Applicant's summary and conclusion
- Conclusions:
- Rats exhibited dark red or black material around eyes and nose in both dose groups. Male rats showed a statistically significant decrease in body weight gain and a corresponding depression in food consumption at the high dose. High dose male rats showed a statistically significant increase in creatinine. Liver weights showed exposure related increase. Since no macroscopic or microscopic changes in rat livers were noted, these weight increases cannot be clearly related to exposure. Male rats at both concentrations exhibited mild renal tubular degeneration and granular cysts which were consistent with hydrocarbon nephropathy. High dose female rats exhibited hydronephrosis.
- Executive summary:
In a 4-week inhalation study (comparable to OECD TG 407), rats exposed to nominal concentrations of 0, 26 (0.22 mg/L) and 98 ppm (0.81 mg/L) (the high concentration was a saturated vapour) t-dodecyl mercaptan for six hours/day, five days/week. Body weight reduction in males (98 ppm; 0.81 mg/L) with a corresponding reduction in food consumption was observed. High-dose males showed an increase in creatinine, and liver weights showed an exposure-related increase. Male rats at both concentrations exhibited mild renal tubular degeneration and granular cysts which were consistent with species-specific hydrocarbon nephropathy. Highdose female rats exhibited hydronephrosis. The LOAEC was 26 ppm (0.22 mg/L).
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