GHS Classification Result

日本語で表示

GENERAL INFORMATION

Item Information
CAS number 107-46-0
Chemical name Hexamethyldisiloxane
Substance ID 23A5018
Fiscal year of classification conducted FY2011
Classifier(s) (Ministries) Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
New/Revised New
Download in Excel format Excel file

REFERENCE INFORMATION

Item Information
Guidance used for classification (External link) Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010)
Environmental Hazards: UN GHS Document (4th revised edition)
Definitions / Abbreviations (Excel file) Definitions / Abbreviations
Model Label by MHLW (External link) MHLW Website (in Japanese Only)
Model SDS by MHLW (External link) MHLW Website (in Japanese Only)
OECD/eChemPortal (External link) eChemPortal

PHYSICAL HAZARDS

Hazard class Classification Symbol
Signal word
Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases (including chemically unstable gases) Not applicable - - - "Liquids" according to GHS definition.
3 Aerosols Not applicable - - - Not an aerosol product.
4 Oxidizing gases Not applicable - - - "Liquids" according to GHS definition.
5 Gases under pressure Not applicable - - - "Liquids" according to GHS definition.
6 Flammable liquids Category 2

Danger
H225
P303+P361+P353
P370+P378
P403+P235
P210
P233
P240
P241
P242
P243
P280
P501
A flash point of -1 degree C is < 23 degrees C, and an initial boiling point of 100 degrees C is > 35 degrees C, therefore, it corresponds to Category 2.
7 Flammable solids Not applicable - - - "Liquids" according to GHS definition.
8 Self-reactive substances and mixtures Not applicable - - - Containing neither chemical groups related to explosibility nor those related to self-reactivity.
9 Pyrophoric liquids Not classified - - - It is conceivable that it does not ignite at normal temperatures from an ignition point of 310 degrees C (IUCLID (2000)).
10 Pyrophoric solids Not applicable - - - "Liquids" according to GHS definition.
11 Self-heating substances and mixtures Classification not possible - - - No established test method suitable for liquid substances.
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified - - - It contains a semimetal (Si), but it is conceivable that it does not react vigorously with water from data on water solubility as 0.897 - 0.964 mg/l (IUCLID (2000)).
13 Oxidizing liquids Classification not possible - - - An organic compound that contains oxygen which is chemically bonded to Si, but the classification is not possible due to no data.
14 Oxidizing solids Not applicable - - - "Liquids" according to GHS definition.
15 Organic peroxides Not applicable - - - An organic compound that does not contain -O-O- structure.
16 Corrosive to metals Classification not possible - - - No data.

HEALTH HAZARDS

Hazard class Classification Symbol
Signal word
Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - On the basis of LD50 values of > 5000 mg/kg (IUCLID (2000)) and > 12224 mg/kg for rats (KemI-Riskline (2002), equivalent to List 2), it was classified as "Not classified."
1 Acute toxicity (Dermal) Not classified - - - On the basis of LD50 values of 12224 mg/kg (male), > 12224 mg/kg (female), and > 2000 mg/kg for rabbits (KemI-Riskline (2002)), it was classified as "Not classified."
1 Acute toxicity (Inhalation: Gases) Not applicable - - - "Liquids" according to GHS definition.
1 Acute toxicity (Inhalation: Vapours) Not classified - - - An LC50 value of > 48 mg/L/1h (> 3614 ppm/4h) was reported in a vapour exposure to rats (IUCLID (2000)).
But an LC50 that is the saturated vapour pressure concentration (368 mg/L/1h) (converted to a 4-hour exposure equivalent value: > 184 mg/L/4h) or higher from a result of another test, in which the saturated vapour pressure concentration exposure to rats for 1 hour results in no death, corresponds to "Not classified."
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - No data.
2 Skin corrosion/irritation Not classified - - - On the basis of a result as "not irritating" in a test using rabbits (EPA Testing Guidelines; GLP) (IUCLID (2000)), it was classified as "Not classified."
3 Serious eye damage/eye irritation Not classified - - - It was concluded that it was minimally irritating from symptoms observed one hour after application to rabbit eyes such as severe irritation of iris and mild to no irritation of the conjunctiva which disappeared at 24 hours or later (KemI-Riskline (2002)). And a maximum mean irritation score (equivalent to AOI) in another test using rabbits in which iritis observed in 1 in 6 rabbits disappeared after 1 to 2 days was 1.8 (the highest possible score 110) (KemI-Riskline (2002)).
On the basis of the information, it was classified as "Not classified."
4 Respiratory sensitization Classification not possible - - - No data.
4 Skin sensitization Classification not possible - - - A repeated insult patch test with 100 subjects reported that any evidence of sensitization was not shown (KemI-Riskline (2002)), and a guinea pig maximization test (GLP compliance) resulted in not sensitizing (IUCLID (2000)).
But it was classified as "Classification not possible” because the both information is from List 2.
5 Germ cell mutagenicity Not classified - - - On the basis of a negative result in a chromosomal aberration test (somatic cell in vivo mutation test) using bone marrow cells after intraperitoneal administration to rats (IUCLID (2000)), it was classified as "Not classified."
Besides, negative results were reported in all of an Ames test, a chromosomal aberration test using mouse lymphoma, and a forward mutation test at the TK gene locus as in vitro tests (IUCLID (2000)).
6 Carcinogenicity Classification not possible - - - No data.
7 Reproductive toxicity Classification not possible - - - An inhalation exposure test was conducted, in which exposure to male and female rats was conducted at least consecutive days 28 days prior to mating, the exposure to males continued through the day prior to necropsy, and the exposure to females was conducted throughout mating and gestation through gestation day 20, and the exposure was reinitiated on lactation day and was continued through the day prior to necropsy. In the test, body weight gains were slightly reduced and mean lung and liver weight were increased in parent animals, and pup survival was slightly decreased at the maximum concentration of 5000 ppm, but no other adverse effects in parents and offspring including sexual function and fertility were reported (HSDB (2006)).
But, it was classified as "Classification not possible" because data on fetal developmental toxicity including teratogenicity were insufficient due to no fetal data at the end of a gestation period.
8 Specific target organ toxicity - Single exposure Classification not possible - - - An oral route is judged to be equivalent to "Not classified" because mortality and toxic symptoms were not observed at each dose in oral administration of 15.4, 23.1, 34.6 g/kg to rats (IUCLID (2000)), and a maximal dose (34600 mg/kg) was much above the upper limit of Guidance values (2000 mg/kg).
On the other hand, mortality and toxic symptoms were not observed in the dermal administration of 2000 mg/kg which is equivalent to the upper limit of Guidance values to rabbits (KemI-Riskline (2002)), but the classification is not possible due to no other information including pathological findings.
In addition, no toxic effects were observed either in vapour inhalation test of 24 mg/L/4h which is above the upper limit of Guidance values (20 mg/L) to rats (IUCLID (2000)) or in another test in which rats were exposed to saturate vapour concentration for 1 hour (KemI-Riskline (2002)), but the classification is not possible due to no further information.
From the above, it was classified as "Classification not possible" in specific target organ toxicity (single exposure) due to lack of dermal and inhalation data despite oral data corresponding to "Not classified."
9 Specific target organ toxicity - Repeated exposure Not classified - - - Adverse effects were not observed in a 28-day oral administration test to rats (IUCLID (2000)), and a high dose of 1500 mg/kg (corresponds to 467 mg/L for 90 days) is above the upper limit of Guidance values, therefore, it corresponds to "Not classified" in an oral route.
Besides, three tests, inhalation administration tests to rats for 1 or 3 months, reported hyaline droplet and protein cast in renal tubule or the incidence and severity of renal tubule regeneration specific for males at doses of 12.7 mg/L (corresponds to 4.23 mg/L for 90 days) or higher in 1-month exposures and at doses of 4.0 mg/L or higher in 3-month exposures, focal local inflammatory lesion in lungs at a dose of 59.2 mg/L (corresponds to 19.7 mg/kg/day for 90 days) in 1-month exposures, atrophy of spermatogenic tubule in testes at a dose of 13.4 mg/L in 3-month exposures (HSDB (2006)).
But all these changes were observed at doses much above the upper limit of Guidance values (1.0 mg/L), therefore it corresponds to "Not classified" in an inhalation route.
Furthermore, a 28-day dermal administration test to rats reported a NOAEL of 500 mg/kg/day (corresponds to 155.5 mg/kg/day for 90 days) (HSDB (2006)), and a 21 to 28-day dermal administration test of 1000 mg/kg/day to rabbits reported no systemic adverse effects except local effects at the site of application (IUCLID (2000)), therefore it corresponds to "Not classified" in a dermal route.
From the above, it was classified as "Not classified" in specific target organ toxicity (repeated exposures) because it is classified as "Not classified" in all 3 of oral, inhalation and dermal routes.
10 Aspiration hazard Classification not possible - - - No data.

ENVIRONMENTAL HAZARDS

Hazard class Classification Symbol
Signal word
Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Classification not possible - - - No data.
11 Hazardous to the aquatic environment (Long-term) Classification not possible - - - No data.
12 Hazardous to the ozone layer Classification not possible - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTES:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.



Updated date:
2016/7/13 Addition of Rationale for the classification

List of GHS Classification Results