GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTES:
Updated date:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS number | 556-67-2 |
| Chemical name | 2,2,4,4,6,6,8,8-Octamethylcyclotetrasiloxane |
| Substance ID | 23A5033 |
| 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 |
| 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 |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (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 3 |  |
H226 |
P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501 |
A flash point of 51 degrees C [closed-cup] (IUCLID (2000)), which is >= 23 degrees C and <= 60 degrees C, corresponds to Category 3. |
| 7 | Flammable solids | Not applicable | - | - | - | "Liquids" according to GHS definition. |
| 8 | Self-reactive substances and mixtures | Not applicable | - | - | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. |
| 9 | Pyrophoric liquids | Classification not possible | - | - | - | No data. |
| 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 0.005 mg/L (SRC (2011)). |
| 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 on oxidizing properties. |
| 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. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity （Oral） | Not classified | - | - | - | On the basis of 3 LD50 values for rats (>2000 mg/kg, >4600 mg/kg, >5000 mg/kg) (IUCLID (2000)), it was classified as "Not classified." |
| 1 | Acute toxicity （Dermal） | Not classified | - | - | - | From an LD50 value of >2400 mg/kg for rats and an LD50 value of >4640 mg/kg for rabbits (IUCLID (2000)), it was classified as "Not classified" in JIS classification (corresponding to Category 5 or "Not classified" in UN GHS classification). |
| 1 | Acute toxicity （Inhalation: Gases） | Not applicable | - | - | - | "Liquids" according to GHS definition. |
| 1 | Acute toxicity （Inhalation: Vapours） | Classification not possible | - | - | - |
The classification is not possible because the category can not be determined from an LC50 value of >12.17 mg/L/4h = 1003 ppm/4h for rats (IUCLID (2000)). Besides, a reference value of gasses as vapour with hardly included mist was applied because the test concentration (12.17 mg/L) is lower than 90 % of the saturated vapour pressure concentration (16.76 mg/L). |
| 1 | Acute toxicity （Inhalation: Dusts and mists） | Classification not possible | - | - | - |
The classification is not possible because the category can not be determined from an LC50 value of >17.6 mg/L/1h = 4.4 mg/L/4h for rats (IUCLID (2000)). Besides, it was considered to be a test by mist because the test concentration (17.6 mg/L) is higher than the saturated vapour pressure concentration (16.76 mg/L). |
| 2 | Skin corrosion/irritation | Not classified | - | - | - |
A semi-occlusive application test of 500 micro L of the test substance to rabbit auricular skins for 24 hours resulted in "not irritating." (IUCLID (2000)) The other test using rabbits resulted in "slightly irritating." (IUCLID (2000)) From the results, it was classified as "Not classified" in JIS classification (corresponding to Category 3 or "Not classified" in UN GHS classification). |
| 3 | Serious eye damage/eye irritation | Not classified | - | - | - | On the basis that both of 2 tests using rabbits reported not irritating (IUCLID (2000)), it was classified as "Not classified." |
| 4 | Respiratory sensitization | Classification not possible | - | - | - | No data. |
| 4 | Skin sensitization | Classification not possible | - | - | - |
Obtained results are not sensitizing in a human repeated insult patch test using 50 subjects (IUCLID (2000)) and not sensitizing in a guinea pig maximization test (IUCLID (2000)). But the classification is not possible because the obtained results are List 2 information. |
| 5 | Germ cell mutagenicity | Not classified | - | - | - |
In addition to a negative result in a rat dominant lethal test (in vivo heritable germ cell mutagenicity test) (IUCLID (2000)), on the basis of the negative result in a rat chromosomal aberration test (in vivo mutagenicity test) by 5-day inhalation exposures (HSDB (2006)), it was classified as "Not classified." Besides, negatives in all of an Ames test, a chromosomal aberration test using CHO cells, and a gene mutation test using L5178Y mouse lymphoma cells were reported as in vitro tests (IUCLID (2000)). |
| 6 | Carcinogenicity | Classification not possible | - | - | - | No data. |
| 7 | Reproductive toxicity | Category 2 |  |
H361 |
P308+P313 P201 P202 P281 P405 P501 |
In an inhalation test exposed to male and female rats for at least 70 consecutive days prior to mating, and females throughout gestation and on lactation periods, extended parturition, dystocia, reductions in mean live litter sizes and a mean number of offspring born in both F0 and F1 generations were observed (HSDB (2006)). In another inhalation test exposed to female rats from 1 month before mating throughout a gestation period, reductions in a number of implantation sites and viable fetuses, increases in pre-implantation and post-implantation losses, a decreased number of corpora lutea were observed (HSDB (2006)), and decreases in food consumption and weight gains in parent animals at a same dose as general toxicity were reported (IUCLD (2000)), therefore, on the basis of adverse effects on reproduction, it was classified in Category 2. Besides, in a test in which male rats were exposed by inhalation prior to mating and during mating and were mated with unexposed females, no adverse effects in reproductive parameters such as days between pairing and coitus, mating indices, fertility indices, and duration of gestation and parturition were observed. Therefore, the above reproductive toxicity was reported to be caused by exposures to females (HSDB (2006)). Besides, it is classified in Repr. Cat. 3; R62 in EC (CLP/GHS) (EC-JRC (ESIS) (2008)). |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible | - | - | - | No data. |
| 9 | Specific target organ toxicity - Repeated exposure | Not classified | - | - | - |
IUCLID reported that female rats showed decreases in weight gains and food consumption in 28-day oral administration of 2000 mg/kg/day but no adverse effects were found in macroscopic findings in necropsy (IUCLID (2000)), also IUCLID said that rats showed no effect other than decreased weight gains and increased liver weights in the 14-day oral administration of 25 to 1600 mg/kg/day, but did not remark on the other effects (IUCLID (2000)). Therefore, from the conclusion that no adverse effects were found in 28-day administration of 2000 mg/kg/day (converted to a 90-day equivalent value: 622 mg/kg/day) and 14-day administration of 1600 mg/kg/day (converted to a 90-day equivalent value: 249 mg/kg/day), it corresponds to "Not classified" in the oral route. On the other hand, increased liver weights as common findings, and changes in female genetic organs such as increased ovarian weights, and inflammations in the lung were observed in 3 tests of 13-week inhalation exposure (vapour) to rats (HSDB (2006)). All of them are found at the concentrations of 500 to more than 900 ppm (6 to 11 mg/L) above the upper limit of guidance values (1 mg/L). Therefore, it corresponds to "Not classified" in the inhalation route. Furthermore, no adverse effects were found at the maximal dose of 960 mg/kg/day (converted to a 90-day equivalent: 221 mg/kg/day) in a 3-week dermal administration test in rabbits. Therefore, it corresponds to "Not classified" in the dermal route. From the above, it was classified as "Not classified" in specific target organ toxicity (repeated exposures) because all 3 of oral, inhalation, and dermal routes were classified as "Not classified." |
| 10 | Aspiration hazard | Classification not possible | - | - | - | No data. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment （Acute） | Not classified | - | - | - | Because acute toxicity data for algae, crustacea, and fish near concentrations around the water solubility were not reported (IUCLID (2000)), It was classified as "Not classified." |
| 11 | Hazardous to the aquatic environment （Long-term） | Category 1 |  |
H410 |
P273 P391 P501 |
If chronic toxicity data are used, then it is classified in Category 1 due to lack of rapid degradability (BIOWIN), and due to 93-day NOEC＝0.0044 mg/L for fish (Oncorhynchus mykiss) (AQUIRE, 2012). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" due to no reported acute toxicity data for algae and crustacea in concentrations up to the water solubility. However, it is classified in Category 4 due to poor water solubility (water solubility, 0.005 mg/L (PHYSPROP Database, 2012), lack of rapid degradability (BIOWIN), and log Kow＞4 (a measured value: 5.1 (PHYSPROP Database, 2012)), and 93-day NOEC＝0.0044 mg/L for fish (Oncorhynchus mykiss) (<1 mg/L, AQUIRE, 2012). It was classified in Category 1 by a comparison between the above results. |
| 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:
|
2016/10/13 Addition of Rationale for the classification |