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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 skin irritation study (Dow Corning Corporation, 1996) repeated 24 hour occluded contact with HMDS caused slight to well defined erythema and moist exfoliation. Semi-occluded and open contacts did not cause test material-related irritation to the skin of albino rabbits.
In the key eye irritation study (Stauffer Chemical Company, 1973) HMDS was not irritating to the eyes of rabbits.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994/05/12 - 1996/04/11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- other: modified methods of CTFA Safety Testing Guidelines, published by the Cosmetic, Toiletry and Fragrancy Association on September 27, 1985, and Preclinical Safety Evaluation of Materials used in Medical Devices HIMA Report 85-1.
- Deviations:
- yes
- Remarks:
- The water contained Trihalomethane (162 μg/l) that was above the EPA recommended level of 100 μg/l.
- GLP compliance:
- yes
- Species:
- guinea pig
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not stated
- Age at study initiation: ca. 3 months
- Weight at study initiation: 2.31-2.59 kg
- Housing: individual housing, in conventional design stainless steel cages
- Diet: Purina 5325 Certified High Fiber Rabbit Chow, ad libitum
- Water: ad libitum
- Acclimation period: 7 day quarantine
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 61-70
- Humidity (%): 40-60
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- other: occluded, semi-occluded or open
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted
- Duration of treatment / exposure:
- 10 applications over 14 days
- Observation period:
- 14 days
- Number of animals:
- 3/group
- Details on study design:
- TEST SITE
- Area of exposure: the back
- Type of wrap if used: For occlusive application; a cotton gauze patch covered with a piece of SARAN plastic wrap, held in place by a cotton cloth bandage taped to their hair for 24 hours. Semi-occlusive wrap; a cotton gauze patch, held in place by a cotton cloth bandage taped to the hair for 24 hours. For unocculuded applicaiton, no wrap was used.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
SCORING SYSTEM: The skin responses were cored on a 0-4 scale, 0 representing no reaction and 4 representing a severe reaction. - Irritation parameter:
- other: Occluded application
- Basis:
- other: Repeated application
- Time point:
- other: Repeated 14 day exposure
- Max. score:
- 2
- Remarks on result:
- other: Very slight to well defined erythema. See Table 1 for complete mean values.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Occlusive group: very slight to well defined erythema and moist exfoliation was observed in all animals in this group by the fourth day of testing and continued throughout the study (abraded sites were healed by the fourth test day). A difference between intact and abraded sites showed a persistence of exfoliation at the abraded sites (exfoliation was present days 4 through 6 at intact sites and days 4 through 10 at abraded sites).
Semi-occlusive group: no test material - related irritation was observed in these animals during the study (abraded sites were healed by the fourth test day). No differences were observed between the intact and abraded sites.
Unoccluded group: No irritation was observed in animals during the course of the study (abraded sites were healed by the fourth day). No differences were seen between the intact and abraded sites. - Other effects:
- There were no apparent test material-related effects on clinical signs, food consumption or body weight gains. The occluded wrapped animals gained less weight than the other groups. This equivocal result was possibly due to the occlusive wrappings.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a test that was conducted in accordance with a suitable test guideline and in compliance with GLP, L2 did not meet the criteria for classification as a skin irritant in the EU. The study involved repeated applications over 14 days and as such exceeds the requirements of the OECD 404 skin irritation study.
Reference
Table 1: Mean Skin irritation scores at various intervals (30 minutes scoring)
Method |
Skin Response
|
Score after application number* |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
||
Occlusive |
ErythemaMax. score: 4 |
0/0 |
0/0 |
0/0 |
2/2 |
2/2 |
1.3/1.3 |
0/1 |
0.7/1.7 |
1/1.7 |
0/1 |
|
Edema Max. score: 4 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
Semi-occlusive |
ErythemaMax. score: 4 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
|
Edema Max. score: 2 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
Unoccluded |
ErythemaMax. score: 4 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
|
Edema Max. score: 2 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
*intact/abraded
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- 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:
- according to guideline
- Guideline:
- other: CFR 191.12 Ch Title 21
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.6-2.1 kg
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated eye.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Duration of treatment / exposure:
- Single instillation, not rinsed.
- Observation period (in vivo):
- Eyes were observed at 24, 48 and 72 hours and scored for irritation.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: Eye irritation was determined according to the method outlined in the "Illustrated Guide for Grading Eye Irritation by Hazardous Substances" (Total possible score 110). If at the end of 72 hours ocular damage appears to be remissable (reversible), the animal is observed for additional 4-7 days before final scoring is possible.
- Irritation parameter:
- other: Ocular irritation.
- Basis:
- other: not specified
- Time point:
- other: 24/48/72h
- Score:
- 0
- Remarks on result:
- other: Not irritating
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of eye irritation were observed.
- Other effects:
- None reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was found not irritating as determined in a reliable study conducted according to generally accepted scientific principles.
Reference
No apparent signs of eye irritation were observed. The test animals appeared normal when necropsied 14 days after treatment.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the key skin irritation study (Dow Corning Corporation, 1996), intact and abraded skin of New Zealand white rabbits (3 animals/group) were exposed to HMDS under occlusive, semi-occlusive or open conditions for ten 24 hour periods over 14 days. There were no apparent test substance-related effects on clinical signs, food consumption or body weight gains. The occluded wrapped animals gained less weight than the other groups. This equivocal result was possibly due to the occlusive wrappings. Under the test conditions, repeated 24-hour occluded contacts with the test substance caused slight to well defined erythema and moist exfoliation. Semi-occluded and non-occluded contacts did not cause test substance-related irritation to the skin of albino rabbits. The observed minor irritation did not meet the criteria for classification.
In the key eye irritation study (Stauffer Chemical Company, 1973) the eyes of New Zealand white rabbits (6 animals) were exposed to a single dose of HMDS and irritation graded after 24, 48 and 72 hours. No apparent signs of eye irritation were observed. The eyes also appeared normal when necropsied 14 days after treatment. Therefore HMDS was concluded not to be irritating to eyes.
Supporting studies for skin and eye irritation are in agreement with the results of the key studies.
Justification for classification or non-classification
Based on the available in vivo skin and eye irritation data, HMDS does not meet the criteria for classification as irritant
according to Regulation (EC) 1272/2008.
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