Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute 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: Information from published industry source (USEPA), limitations in design and/or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1965
Report date:
1965

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Two Sprague-Dawley rats per sex per dose group were exposed by inhalation to the test substance for 4 hours. After an observation period of 14 days, animals were necropsied.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1,1,3,3,3-hexamethyldisilazane
EC Number:
213-668-5
EC Name:
1,1,1,3,3,3-hexamethyldisilazane
Cas Number:
999-97-3
Molecular formula:
C6H19NSi2
IUPAC Name:
1,1,1-trimethyl-N-(trimethylsilyl)silanamine
Details on test material:
- Name of test material (as cited in study report): Hexamethyldisilazane
- Molecular formula (if other than submission substance): C6H19NSi2

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 250 g
- Housing: individually, stock cages
- Diet: ad libitum, standard laboratory rat diet from Wayne Lab Blox, Allied Mills, Chicago, Illinois
- Water: ad libitum
- Acclimation period: 5 days

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: glass inhalation chamber
- Exposure chamber volume: 5.5 liter
- System of generating vapour: vapours were produced by bubbling dried metered arid thorugh the undiluted test material. Additional dried metered air was mixed with the vapour stream to achieve the desired concentration levels.

POSITIVE CONTROL
- No. of animals: 4 groups of 2 animals per sex per dose
- Positive control compound: 10% ammonium hydroxide solution
- Concentrations: 8.5, 18.9, 33, 72.5 mg/L air
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
ca. 4 h
Remarks on duration:
Except 60.5 and 94.3 mg/L dose group, which were exposed 110 and 70 min., resp.
Concentrations:
5.6, 19, 30.4, 60.5, 94.3 mg/L air
No. of animals per sex per dose:
2
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
The mortality data were analyzed statistically, employing the technique of Litchfield and Wilcoson (J.T. Litchfield, Jr. and F. Wilcoxon, "A Simplified Method of Evaluating Dose-Effect Experiments." J. Pharm. & Exp. Ther., Vol 96, No. 2, pp. 99-113, 1949.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
10.3 mg/L air
Based on:
test mat.
95% CL:
6.4 - 16.5
Exp. duration:
4 h
Mortality:
- No mortality observed in animals exposed to 5.6 mg/L
- All animals exposed to 19, 30.4, 60.5, 94.3 mg/L died, within 70 minutes to 48 hours after exposure
Clinical signs:
other: - Hypoactivity, hyperpnoea and ataxia were observed in animals exposed to 30.4, 60.5 or 94.3 mg/L, after 4 to 14 minutes of exposure. Sedation was noted at the 10 to 21 minute point. Sedation and hyperpnoea persisted until death. - Hypoactivity was observ
Gross pathology:
- Necroscopy revealed mild lung haemorrhage in animals exposed to 19, 30.4, 60.5 or 94.3 mg/L hexamethyldisilazane.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information