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EC number: 203-492-7 | CAS number: 107-46-0
- 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
Endpoint summary
Administrative data
Description of key information
In the key oral acute toxicity study (Bushy Run Research Center, 1982) in rats the LD50 was determined to be > 16.0 ml/kg (12.16 g/kg bw) for males and females.
The key inhalation study (Dow Corning Corporation, 1997) in rats gave an LC50 of 15956 ppm (ca. 106 mg/l).
In the key acute dermal toxicity study (Institut Francais de Recherches et Essais Biologiques, 1982), the LD50 for male and female rats was determiend to be >2000 mg/kg.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- not in compliance with GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Hilltop-Wistar albino rats, weighing between 200 and 300 g, received the test material by stomach intubation with a ball-end stainless steel needle. The sample was injected through the needle by means of a syringe and doses were varied by adjusting the volume of the test material. The rats were fasted overnight before dosing. Five males and 5 females were included on each level (16.0 and 8.0 ml/kg).
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Hilltop-Wistar albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- weighing between 200 and 300 g
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE: Not applicable
MAXIMUM DOSE VOLUME APPLIED: Not stated - Doses:
- 8.0 and 16.0 ml/kg
- No. of animals per sex per dose:
- 5/sex/group
- Control animals:
- no
- Details on study design:
- Hilltop-Wistar albino rats, weighing between 200 and 300 g, received the test material by stomach intubation with a ball-end stainless steel needle. The sample was injected through the needle by means of a syringe and doses were varied by adjusting the volume of the test material. The rats were fasted overnight before dosing. Five males and 5 females were included on each level (16.0 and 8.0 ml/kg). The animals were maintained on appropriate commercial diet and municipal water. Both were available ad libitum except during period of fasting, manipulation or restraint. Animal weights were recorded at 0 days (before dose), 7 days and 14 days (just prior to sacrifice). At death or sacrifice, each animal was subjected to gross pathologic evaluation.
- Statistics:
- LD50s were calculated by the moving average method (Thompson, 1947) and were based on a 14-day observation period.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 16 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: corresponding to 12.16 g/kg
- Mortality:
- MALES:
16.0 ml/kg Dead/Dosed: 0/5
8.0 ml/kg Dead/dosed: 1/5
FEMALES:
16.0 ml/kg Dead/Dosed: 0/5
8.0 ml/kg Dead/Dosed: 0/5 - Clinical signs:
- other: MALES: 16.0 ml/kg None noted. 8.0 ml/kg: In the animal that died, sluggishness, unsteady gait at 4 min; death at 15 min. In survivors, none noted. FEMALES: 16.0 ml/kg None noted. 8.0 ml/kg None noted.
- Gross pathology:
- MALES:
16.0 ml/kg : Nothing remarkable.
8.0 ml/kg In animal that died, lungs with dark spots; liver dark; stomach liquid-filled, injected; intestines and kidneys red. In survivors, nothing remarkable.
FEMALES:
16.0 ml/kg : Nothing remarkable.
8.0 ml/kg Nothing remarkable. - Other findings:
- No other findings reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 was determined to be > 16.0 ml/kg, dosed as received, in both male and female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 12 160 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Principles of method if other than guideline:
- The mean actual exposure concentrations were significantly higher than OECD limit test guideline of 5 mg/l.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, NC
- Age at study initiation:Males approximately 8 weeks and females approximately 10 weeks old when exposed.
- Weight at study initiation: 126 - 150 g
- Housing: Individually in stainless steel, wire mesh-bottom cages
- Diet: Purina rodent chow ad libitum except during exposure
- Water: Ad libitum
- Acclimation period: One week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 - 70
- Air changes (per hr): Not stated
- Photoperiod (12 hrs dark /12 hrs light):
IN-LIFE DATES: From: 15th February 1994 To: 3rd March 1994 - Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Stainless steel and glass exposure chambers
- Exposure chamber volume: 120 litre
- Method of holding animals in test chamber:
- Source and rate of air: Ambient air; 10-15 air changes per hour (20.4 - 20.5 litres per minute)
- Method of conditioning air: HEPA and charcoal filters
- System of generating particulates/aerosols: Not applicable
- Method of particle size determination: Not applicable
- Treatment of exhaust air: HEPA and charcoal filters then passed through water scrubber
- Temperature, humidity in chamber: 22.9 - 23.9 °C; 52.0 - 61.2% humidity
TEST ATMOSPHERE
- Brief description of analytical method used: Gas chromatography
- Samples taken from breathing zone: Yes
VEHICLE
Not applicable
TEST ATMOSPHERE
- Particle size distribution: Not applicable
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): Not applicable - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- GC
- Duration of exposure:
- 4 h
- Concentrations:
- 11,000; 14,000 and 18,000 (nominal); 10,067; 14,050 and 16,659 ppm (as measured by gas chromatography)
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, gross pathology - Statistics:
- No statistical analysis included.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 15 956 ppm
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: 95% CL = 14,024-34,045
- Sex:
- male/female
- Dose descriptor:
- other: NOEL
- Effect level:
- 10 067 ppm
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- See Table 1.
One animal in the mid-dose group was sacrificed for human reasons on Day 2. This was not included in the statistical analysis. - Clinical signs:
- other: During the 4-hour exposure, some of the animals exposed to concentrations of 14,050 and 16,659 ppm test material experienced prostration and convulsions. Ataxia was also observed in the high exposure group. The primary clinical sign after the exposure was
- Body weight:
- No apparent effects on body weight gains were observed.
- Gross pathology:
- In animals that died, congestion and/or haemorrhage of various lobes of the lung were observed in males and females. Congestion of the lungs was also noted in one female from each of the two higher exposure groups at the final sacrifice of the animals that survived exposure.
- Other findings:
- - Potential target organs: Lung
- Other observations: Response was generally consistent between males and females. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- An acute inhalation LC50 of 15,956 ppm with (95% confidence limits of 14,024-34,045) was determined for male and female rats in an reliable study conducted according to an appropriate test protocol, and in compliance with GLP. This is equivalent to ca. 106 mg/l.
Reference
Table 1: Concentrations, exposure conditions and number of evident toxicity per animals treated
Nominal Conc. (ppm) |
Analytical Conc. (ppm) |
Number dead/Number exposed |
||
Males |
Females |
Combined |
||
11000 |
10067 |
0/5 |
0/5 |
0/10 |
14000 |
14050 |
1/5 |
1/5 |
2/10 |
18000 |
16659 |
3/5 |
3/5 |
6/10 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 106 000 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- It was not compliant with GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA CREDO
- Weight at study initiation: 180-200g
- Housing: in individual cages (37.5x17x15 cm)
- Diet: IFFARAT feed, ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1C
- Humidity (%): 50 +/- 10
- Air changes (per hr): 8
IN-LIFE DATES: From: To: - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: shaved dorsal skin
- Type of wrap if used: an aluminium sheet, held in place with adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.62 ml/kg
- Duration of exposure:
- Single application, not rinsed
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5M, 5F
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- No statistical analysis reported in the study report.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died during the study.
- Clinical signs:
- other: No skin reactions were noted during the exposure or over the 14 day observation period.
- Gross pathology:
- Not reported.
- Other findings:
- Not reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An acute dermal LD50 value of >2000 mg/kg was determined for male and female rats in a reliable study conducted according to an appropriate test protocol. Not conducted according to GLP.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Other results from supporting studies in rats are in agreement with the conclusion that D4 is not harmful via the oral route.]
In the key acute oral study (Bushy Run Research Center, 1982) Hilltop-Wistar rats (5 animals/sex/dose) were administered 8 or 16 ml/kg bw of HMDS by oral gavage then observed for 14 days. Animal weights were recorded at 0 days (before dosing), 7 days and 14 days (just prior to sacrifice). At death or sacrifice, each animal was subjected to gross pathologic evaluation. The only death was a male in the low dose group, which showed sluggishness and unsteady gait at 4 minutes and death at 15 minutes. Necropsy revealed lungs with dark spots, dark liver, liquid-filled, injected stomach, and red intestines and kidneys. There were no adverse findings in the animals that survived. The LD50 was >16 ml/kg bw (equivalent to 12160 mg/kg bw). A number of supporting studies (Reliability 2 or 4) confirm that the acute oral LD50 for HMDS in rats is well in excess of the dosing limit of current guidelines and it is therefore not harmful for acute exposures via the oral route.
In the key acute inhalation study (Dow Corning Corporation, 1997) Sprague-Dawley rats (5 animals/sex/dose) were exposed to HMDS at concentrations of 10067; 14050 and 16659 ppm for 4 hours then observed for 14 days.
At death or sacrifice, each animal was subjected to gross pathologic evaluation
Animals exposed to concentrations of 14050 and 16659 ppm experienced prostration and convulsions. Ataxia was also observed in the high exposure group. The primary clinical sign after the exposure was porphyrin staining of the eyes and face; this was evident in some of the animals of the two higher exposure groups for the entire observation period. In animals that died, congestion and/or hemorrhage of various lobes of the lung were observed in males and females. Congestion of the lungs was also noted in one female from each of the two higher exposure groups at the final sacrifice of the animals that survived exposure. The LC50 was 15,956 ppm with (95% confidence limits of 14,024-34,045). There are no reliable supporting studies for the acute inhalation route for HMDS.
In the key acute dermal study (Institut Francais de Recherches et Essais Biologiques, 1982) Sprague-Dawley rats (5 animals/sex) had HDMS applied to their skin under occlusive conditions at a dose of 2000 mg/kg bw, the skin was not rinsed and the animals were then observed for 14 days. There were no mortalities, clinical signs of toxicity, adverse necropsy findings or indications of local skin irritation. There are an additional two studies that support the conclusion that HMDS is not harmful for acute exposures via the dermal route.
Justification for classification or non-classification
Based on the available oral, dermal and inhalation toxicity data, HMDS does not meet the criteria for classification for acute toxicity
according to Regulation (EC) 1272/2008.
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