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EC number: 213-668-5 | CAS number: 999-97-3
- 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
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- Auto flammability
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- Additional physico-chemical information
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- Endpoint summary
- Stability
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- 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 an acute oral toxicity study with 1,1,1,3,3,3-hexamethyldisilazane (CAS 999-97-3, EC 213-668-5), conducted according to a protocol comparable to the now-deleted OECD Test Guideline 401 but without information on GLP compliance, the LD50 was concluded to be 1.1 ml/kg bw/day (equivalent to 847 mg/kg bw based on a density of 0.77 g/cm³) (Bayer, 1988).
In an acute inhalation toxicity study conducted according to OECD Test Guideline 403 and in compliance with GLP, the LC50 value for 1,1,1,3,3,3-hexamethyldisilazane in the Sprague-Dawley rat was determined to be 1516 ppm (equivalent to 10000 mg/m³) (Dow Corning Corporation, 2007).
In an acute dermal toxicity study conducted according to a protocol similar to OECD Test Guideline 402, but without information on GLP compliance, the LD50 for 1,1,1,3,3,3-hexamethyldisilazane was concluded to be 544 mg/kg bw in females and 585 mg/kg bw in males (based on a density of 0.77 g/cm³) (Bushy Run Research Centre, 1981).
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
- Study period:
- 03.06.80 to 05.08.80
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline. It was not compliant with GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- Study was conducted prior to the adoption of OECD test guidelines and GLP
- GLP compliance:
- no
- Remarks:
- Pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Fasting period before study: Yes, but period not given.
- Housing: Groups of 5 in Makrolon Type II cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 ±2
- Humidity (%): 60 ±5
- Air changes (per hr): about 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 03.06.80 To: 05.08.80 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 1.5 ml/kg bw
- Doses:
- 0.1, 1.0, 1.2, 1.4 and 1.5 ml/kg bw
- No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily observations and weighing once per week.
- Necropsy of survivors performed: yes
- Other examinations performed: Not clear - Statistics:
- The acute oral LD50 was determined by probit-regression analysis.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1.1 mL/kg bw
- 95% CL:
- >= 1 - <= 1.2
- Remarks on result:
- other: equivalent to 847 mg/kg bw based on a density of 0.77 g/cm³
- Mortality:
- See Table 1.
- Clinical signs:
- other: At doses of 1.0 ml/kg bw and above paralysis of hind limbs, sedation, anaesthesia and poor general condition were observed.
- Gross pathology:
- Redness of the stomach mucosal membrane among animals that died during the study and those sacrificed at the end of the observation period.
- Other findings:
- None reported
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- In an acute oral toxicity study with 1,1,1,3,3,3-hexamethyldisilazane (CAS 999-97-3), conducted according to a protocol comparable to the now-deleted OECD Test Guideline 401 but without information on GLP compliance, the LD50 was concluded to be 1.1 ml/kg bw/day (equivalent to 847 mg/kg bw based on a density of 0.77 g/cm³).
Reference
Table 1 Summary of mortality
Dose (ml/kg bw) | Dead/dosed | Days to death | Mortality (%) |
Males | |||
0.1 | 0/5 | - | 0 |
1.0 | 2/5 | 3 | 40 |
1.2 | 1/5 | 2 | 20 |
1.4 | 5/5 | 4 | 100 |
1.5 | 5/5 | 2 | 100 |
Females | |||
0.1 | 0/5 | - | 0 |
1.0 | 2/5 | 3 | 40 |
1.2 | 4/5 | 4 | 80 |
1.4 | 4/5 | 7 | 80 |
1.5 | 5/5 | 2 | 100 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 847 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:
- 30.08.2006 to 17.07.2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- Exposure period of six hours.
- GLP compliance:
- yes
- Test type:
- other: Similar to OECD 403
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portage
- Age at study initiation: ≥10 weeks
- Weight at study initiation: Males: ≥223 g. Males: ≥347 g
- Fasting period before study: No
- Housing: Individually in suspended wire-mesh cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Six/seven days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 32-64
- Air changes (per hr): 12.1 to 17.1
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 05.10.2006 To: 03.01.2007 - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Test substance vapour was generated using a heated stainless steel J-tube containing a column of stainless steel beads into which test substance was metered.
- Exposure chamber volume: 450 litre
- Method of holding animals in test chamber: None
- Source and rate of air: Building aor was passed through a Nash Air Compressor
- Method of conditioning air: Compressed air was passed through a series of filters to remove contaminants.
- Treatment of exhaust air: No data
- Temperature, humidity, pressure in air chamber: No data
TEST ATMOSPHERE
- Brief description of analytical method used: Chamber atmosphere was analysed using a Varian 3400 gas chromatograph equipped with a flame ionization detector.
- Samples taken from breathing zone: No data - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Chamber atmosphere was analysed using a Varian 3400 gas chromatograph equipped with a flame ionization detector.
- Duration of exposure:
- 6 h
- Concentrations:
- Target: 900, 1200 and 3450 (5.9, 7.8 and 22.6 mg/L); Nominal: 913, 1242, and 3755 ppm; Measured: 885, 1167 and 3400 ppm
- No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (animals killed on Day 15)
- Frequency of observations and weighing: Daily observations. Body weight measured on days 1 (first day of exposure), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: None - Statistics:
- The mean lethal nominal chamber concentration (LC50), 95% confidence interval and approximate slope of the dose response curve were calculated using a SAS/STAT Spearman-Karber analysis. Means and standard deviations were determined for other data as appropriate.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 1 516 ppm
- Exp. duration:
- 6 h
- Remarks on result:
- other: equivalent to 10000 mg/m3
- Mortality:
- All animals on the 3755 ppm group died during the latter part of the six-hour exposure. In the 1242 ppm group 50% of the animals died prior to the scheduled terminal sacrifice. No animals died in the 913 ppm group.
- Clinical signs:
- other: There were no signs of toxicity before death in the animals of the highest dose group. In the lowest dose group clinical observations were: inactivity, lacrimation, eye lids partially closed, cold to the touch, muscles soft/limp, respiration slow/noisy an
- Body weight:
- Body weight gains for 913 ppm group averaged approximately 12%, while those for the surviving animals in the 1242 ppm group averaged approxiately -1% over the 15 day observation period.
- Gross pathology:
- In the 3755 ppm group, five animals (three females and two males) presented with liver congestion, one of which also presented with spleen congestion, and two animals (males) presented with intestine (jejunum) congestion. This represents a non-specific finding that indicates some increased circulation to the organ. The remaining three animals showed no visible lesions. All of the animals in this group died during the exposure. In the 913 ppm group, one male animal presented with kidney foci depressed (minimal) and the remaining animals showed no visible lesions. The minimal focal depressions in the kidneys of the one male represent a common spontaneous finding with no toxicological significance. All of the animals in this group were necropsied at the scheduled terminal sacrifice on day 15. In the 1242 ppm group, three animals (one male and two females), found dead on days 4 or 5, presented with decreased stomach ingesta, two of which (females) also presented with liver discoloration (pale). The decreased stomach ingesta indicates that the animals were too sick to eat. Pale livers can be caused by lipidosis or from autolysis; since these animals were found dead, it is assumed the latter. The two other animals which were found dead (on day 2) and the remaining animals which were necropsied at the scheduled terminal sacrifice showed no visible lesions.
- Other findings:
- None reported
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In an acute inhalation toxicity study (reliability score 1) conducted according to OECD Test Guideline 403 and in compliance with GLP, the LC50 value for 1,1,1,3,3,3-hexamethyldisilazane in the Sprague-Dawley rat was determined to be 1516 ppm (equivalent to 10000 mg/m³).
Reference
Table 1 Mortality results and time to death.
Sex | Exposure concentration (ppm) | Number of deaths | Time to death |
Male | 3755 | 5/5 | During exposure period |
1242 | 3/5 | Two on Day 2 and one on Day 5 | |
913 | 0/5 | No deaths | |
Female | 3755 | 5/5 | During exposure period |
1242 | 2/5 | One on each of Days 4 and 5 | |
913 | 0/5 | No deaths |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 10 000 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:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline. 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:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 2-3 Kg
- Fasting period before study: No data
- Housing:No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: No data - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: Impervious sheet
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Males: 1.0, 0.71 and 0.5 ml/kg bw; females: 16.0, 4.0, 1.0, 0.5 and 0.25 ml/kg bw
- Concentration (if solution): Undiluted
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- 1.0, 0.71, and 0.50 mL/kg bw (770, 550, and 385 mg/kg bw based on a density of 0.77 g/cm3) in males and 16.0, 4.0, 1.0, 0.5, and 0.25 mL/kg bw (12,320, 3080, 770, 385, 193 mg/kg bw based on a density of 0.77 g/cm3) in females
- No. of animals per sex per dose:
- Four (except 16 and 4 ml/kg bw levels used two females each)
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made daily. Weights were measured before dosing and on Days 7 and 14.
- Necropsy of survivors performed: yes - Statistics:
- LD50s were calculated using the 'moving average method'.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 585 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 544 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Males: 4/4, 1/4 and 0/4 at 1.0, 0.71 and 0.5 ml/kg bw, respectively.
Females: 2/2, 2/2, 4/4, 0/4 and 0/4 at 16.0, 4.0, 1.0, 0.5 and 0.25 ml/kg bw, respectively. - Clinical signs:
- other: See Table 1
- Gross pathology:
- See Table 1
- Other findings:
- See table 1
- Interpretation of results:
- Category 3 based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In an acute dermal toxicity study conducted according to a protocol that was comparable to OECD Test Guideline 402, but without information on GLP compliance, the LD50s for 1,1,1,3,3,3-hexamethyldisilazane (CAS 999-97-3) was concluded to be 544 mg/kg bw in females and 585 mg/kg bw in males (based on density of 0.77 g/cm3).
Reference
Table 1 Summary of mortality, clinical and necropsy findings.
Group (ml/kg bw) | Number of deaths/total exposed | Time to death (d) | Clinical observations | Necropsy findings |
Males | ||||
0.5 | 0/4 | - | Sluggishness on Days 1 and 2 (2/4), skin erythema, edema, necrosis on Day 1 and desquamation by Day 14. | Trachea red (1/4), liver with tan foci (coccodiae; 1/4) |
0.71 | 1/4 | 3 | Prostration in one animal, skin erythema and necrosis, and scabs by Day 14. | Nothing remarkable |
1.0 | 4/4 | 1, 1, 2, 3 | Prostration in two animals, skin erythema, edema and necrosis | Lung & liver dark (1/4), trachea red (2/4), bladder distended filled with red/yellow liquid (1/4) |
Females | ||||
0.25 | 0/4 | - | Capillary injection, erythema, necrosis, spots of ecchymosis on Day 1, desquamation, scabs at 14 days. | Lungs mottled dark red (2/4) and trachea slight redness along mucous lining (1/4) |
0.5 | 0/4 | - | Sluggishness on Day 1, skin erythma, edema and necrosis on Day 1 with desquamation and scabs by Day 14. | Lungs and trachea dark red (1/4) |
1.0 | 4/4 | 1, 1, 1, 3 | Lethargy, slow and shallow breathing (1 hour), skin erythema and necrosis | Lungs mottled dark red (2/4) and trachea dark red (1/4) |
4.0 | 2/2 | 1, 1 | Signs of discomfort, lethargy slow and shallow breathing (30 mins), skin erythema and necrosis | Lungs with dark red patches |
16.0 | 2/2 | 0, 0 (within 2 hours) | Signs of discomfort, skin erythema and necrosis | Nothing remarkable |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 544 mg/kg bw
Additional information
In the key acute oral toxicity study conducted according to a protocol similar to the now deleted OECD Test Guideline 401 and without information on GLP compliance (Bayer, 1988), Wistar rats (5/sex/dose) were exposed by oral gavage to 1,1,1,3,3,3-hexamethyldisilazane at doses of 0.1, 1.0, 1.2, 1.4 and 1.5 ml/kg bw. The animals were then observed for 14 days for signs of toxicity. Animals were weighed before dosing and on day 7 and 14 of the observation period. At doses of 1.0 ml/kg bw and above paralysis of hind limbs, sedation, anaesthesia, poor general condition and reduced body weight were observed. Necropsy revealed redness of the stomach mucosal membrane among animals that died during the study and those that were sacrificed at the end of the observation period. No deaths or signs of toxicity were observed at the lowest dose. There were 4/10, 5/10 (1 female and 4 males), 9/10 and 10/10 deaths at 1.0, 1.2, 1.4 and 1.5 ml/kg bw. The LD50 was calculated to be 1.1 ml/kg bw/day.
In the supporting acute oral toxicity study conducted according to a protocol similar to the now deleted OECD Test Guideline 401 and without information on GLP compliance, 1,1,1,3,3,3-hexamethyldisilazane was administered by oral gavage to BR Long-Evans derived rats (5/sex/dose) at doses of 0.05, 0.1, 0.25, 0.50, 0.90, 0.95, 1.00, 2.50 ml/kg bw. The animals were then observed for 14 days. There were no deaths up to a dose of 0.9 ml/kg bw. Mortalities for 0.95, 1 and 2.5 ml/kg were 7/10, 6/10 and 10/10, respectively. All animals died within one day of dosing.
The LD50 was calculated to be 1.0 ml/kg bw. Clinical signs at doses of 0.05, 0.1 and 0.25 ml/kg bw included decreased activity and ataxia. At 0.5 and 0.9 ml/kg, clinical signs included decreased activity or sedate, ataxia or incoordination, urinary incontinence and decreased respiration. In addition, animals dosed at 0.9 ml/kg also exhibited exophthalmia, and extremities bright red in colour. Clinical signs at dose levels of 0.95 ml/kg and higher were similar to those observed at lower dose levels, and may also have included one or more of the following: pilo-erection, lacrimation, cold to touch and salivation (FDRL, 1977).
The key study for acute oral toxicity was one of two reliability score 2 studies. The most recent was selected as the key study; however, these studies gave very similar results. Many reliability score 4 studies are also available to support the LD50 from the key study.
In the key acute inhalation toxicity study (Dow Corning Corporation, 2007), conducted according to OECD Test Guideline 403 and in compliance with GLP, male and female Sprague-Dawley rats were exposed to 1,1,1,3,3,3-hexamethyldisilazane at nominal concentrations of 913, 1242, and 3755 ppm via whole-body inhalation for six hours. Following exposure, the animals were observed daily for clinical signs of toxicity. Weights were measured before dosing and on Days 8 and 15. The animals were examined macroscopically during necropsy. All animals in the 3755 ppm group died during the latter part of the 6-hour exposure. In the 1242 ppm group, 50% of the animals died prior to the scheduled terminal sacrifice. No animals died in the 913 ppm group. Clinical observations consisted of inactivity, lethargy, shallow and laboured breathing, lacrimation, cold to touch and soiling (urogenital and eyes). Necropsy findings consisted of liver, spleen and intestine congestion in the 3755 ppm group, one instance of focal depressions in the kidney in the 913 ppm group and decreased stomach ingesta and liver discolouration in the 1242 ppm group. These findings were judged to be non-specific, spontaneous or autolytic changes with no toxicological significance. The LC50was concluded to be 1516 ppm (equivalent to 10000 mg/m³).
Other supporting studies for the inhalation route were available. The most reliable study, which had a reliability score 1, was selected as the key study.
In the key acute dermal toxicity study (Bushy Run Research Center, 1981), conducted according to a protocol similar to OECD Test Guideline 402, but without information on GLP compliance, male and female New Zealand white rabbits were subject to an occlusive 24-hour dermal application of undiluted 1,1,1,3,3,3-hexamethyldisilazane at doses of 1.0, 0.71, and 0.50 ml/kg bw (770, 550, and 385 mg/kg bw based on density of 0.77 g/cm³)
and 16.0, 4.0, 1.0, 0.5, and 0.25 ml/kg bw (12 320, 3080, 770, 385, 193 mg/kg bw based on a density of 0.77 g/cm³ ), respectively. Following exposure the animals were observed daily for clinical signs of toxicity. Weights were measured before dosing and on Days 7 and 14. The animals were observed macroscopically during necropsy. At doses of 1.0 ml/kg bw all animals died, and one male died at 0.71 ml/kg bw. There were no other deaths. All groups showed signs of severe skin irritation. The observed clinical signs included sluggishness, prostration, lethargy, slow and shallow breathing, discomfort and skin corrosion. The LD50 was concluded to be 544 mg/kg bw in females and 585 mg/kg bw in males (based on a density of 0.77 g/cm³).
The key study was the only one
reliable study for the dermal route; however, supporting reliability 4
studies gave similar results.
Justification for classification or non-classification
Based on the available data, 1,1,1,3,3,3-hexamethyldisilazane (CAS 999-97-3, EC 213-668-5) requires classification as acute oral toxicity Cat. 4 (oral) 'H302: Harmful if swallowed', acute dermal toxicity Cat. 3 'H311: Toxic in contact with skin' and acute toxic (vapour) toxicity Cat. 4 'H332: Harmful if inhaled' according to Regulation (EC) 1272/2008.
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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