GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTES:
Updated date:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS number | 75-98-9 |
| Chemical name | 2,2-Dimethylpropanoic acid |
| Substance ID | 23A5070 |
| 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 | - | - | - |
"Solids" according to GHS definition. |
| 3 | Aerosols | Not applicable | - | - | - |
Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable | - | - | - |
"Solids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable | - | - | - |
"Solids" according to GHS definition. |
| 6 | Flammable liquids | Not applicable | - | - | - |
"Solids" according to GHS definition. |
| 7 | Flammable solids | Classification not possible | - | - | - |
No data. |
| 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 | Not applicable | - | - | - |
"Solids" according to GHS definition. |
| 10 | Pyrophoric solids | Not classified | - | - | - |
It is conceivable that it does not ignite at normal temperatures from an ignition point of >500 degrees C (GESTIS (Access on June. 2011)). |
| 11 | Self-heating substances and mixtures | Classification not possible | - | - | - | No established test method suitable for solid substances with a melting point of 140 degrees C or lower. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable | - | - | - |
Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
| 13 | Oxidizing liquids | Not applicable | - | - | - |
"Solids" according to GHS definition. |
| 14 | Oxidizing solids | Not applicable | - | - | - |
An organic compound that contains oxygen which is not chemically bonded to elements other than carbon or hydrogen. |
| 15 | Organic peroxides | Not applicable | - | - | - |
An organic compound that does not contain -O-O- structure. |
| 16 | Corrosive to metals | Classification not possible | - | - | - |
No established test method suitable for solid substances. Besides, there is information that it is corrosive to cast iron, copper, and zinc (Hommel (1996)). |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity （Oral） | Category 4 |
 |
H302 |
P301+P312 P264 P270 P330 P501 |
Three LD50 values for rats: 900 to 1800 mg/kg (IUCLID (2000)), 500 to 5000 mg/kg (IUCLID (2000)), and 2000 mg/kg (HPVIS (2009), corresponding to List 2) correspond to Category 4, Category 4 to "Not classified," and Category 4 respectively. It was classified in Category 4 to which most of them correspond. |
| 1 | Acute toxicity （Dermal） | Category 4 |
|
H312 |
P302+P352 P280 P312 P322 P363 P501 |
From two LD50 values for rats: 1800 to 3600 mg/kg (IUCLID (2000)) and 1900 mg/kg (HSDB (2008)) which correspond to Category 4 to "Not classified" and Category 4 respectively, it is classified in Category 4 to which most of them correspond. From two LD50 values for rabbits: 350 to 2880 mg/kg (IUCLID (2000)) and 3160 mg/kg (HPVIS (2009)) which correspond to Category 3 to "Not classified" and "Not classified" respectively, it is classified as "Not classified" to which most of them correspond. By adopting the higher classification for rats between rats and rabbits, it was classified in Category 4 from the above. |
| 1 | Acute toxicity （Inhalation: Gases） | Not applicable | - | - | - |
"Solids" according to GHS definition. |
| 1 | Acute toxicity （Inhalation: Vapours） | Classification not possible | - | - | - |
An LC50 value of not less than a saturated vapour pressure concentration from no deaths after 4-hour exposure to the saturated vapour pressure concentration in rats, and an LC50 value of >4 mg/L/6h (>4.9 mg/L/4h) from 2 deaths out of 10 rats after 6-hour exposure to 4 mg/L in rats were reported. But the classification is not possible because the category could not be determined only by these results. |
| 1 | Acute toxicity （Inhalation: Dusts and mists） | Classification not possible | - | - | - |
No data. |
| 2 | Skin corrosion/irritation | Category 2 |
|
H315 |
P302+P352 P332+P313 P264 P280 P321 P362 |
It was assessed as "highly irritating" resulting from 24, 48-hour average scores of 2.8 and 2.6 for erythema and edema respectively and maximum score of 4 shown in 2 out of 4 animals throughout the 7-day observation period in a Draize test by 24-hour occlusive application of 0.5 mL of this substance to rabbits. (IUCLID (2000)) And it was assessed as "moderately irritating" in another Draize test by 24-hour occlusive application of 0.5 mg of this substance to rabbits. (IUCLID (2000)) From the above, it was classified in Category 2. |
| 3 | Serious eye damage/eye irritation | Category 2A |
|
H319 |
P305+P351+P338 P337+P313 P264 P280 |
It was assessed as "highly irritating" resulting from 24, 48, and 72-hour average scores of 2.0 for conjunctival redness, 2.8 for conjunctival edema, 2.0 for corneal opacity and 1.8 for iritis, and the disappearance of conjunctival edema only at the end of the 7-day observation period in a Draize test applied 0.2 mL of undiluted this substance to rabbits. (IUCILD (2000)) Furthermore, it was assessed as "moderately irritating" result in another test applied 0.1 mL of this substance into rabbit conjunctival sacs. (HPVIS (2009)) Therefore it was classified in Category 2A. |
| 4 | Respiratory sensitization | Classification not possible | - | - | - |
No data. |
| 4 | Skin sensitization | Not classified | - | - | - |
From an assessment result as "not sensitizing" in a maximization test in guinea pigs (OECD TG 406) with a positive rate of 0% (0/20) after a challenge (IUCLID (2000)), it was classified as "Not classified." |
| 5 | Germ cell mutagenicity | Classification not possible | - | - | - |
The classification is not possible due to no in vivo test data. Besides, as in vitro tests, both an Ames test and a chromosomal aberration test using rat hepatocytes reported negative results. (IUCLID (2000)) |
| 6 | Carcinogenicity | Classification not possible | - | - | - |
Lack of data. Besides, in a 47-week dermal administration test at a weekly dose of 100 micro g/mouse, it was reported that an increased incidence of skin tumors was not observed (IUCLID (2000)), but neither a statistical analysis of systemic tumors was conducted nor a conclusion was described. |
| 7 | Reproductive toxicity | Classification not possible | - | - | - |
No data. |
| 8 | Specific target organ toxicity - Single exposure |
Category 2 (central nervous system),
Category 3 (narcotic effects) |
 |
H371 H336 |
P309+P311 P260 P264 P270 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
Observed signs in rats after oral administration were lethargy and piloerection at about 450 mg/kg or higher (IUCLID (2000)) and depression, dyspnea, depressed reflexes, and lack of coordination at 1450 mg/kg or higher. (HSDB (2008), HPVIS (2009)) Observed signs in rabbits after dermal administration were depression, dyspnea, and unsteady gait at doses of 794 mg/kg or higher. (HPVIS (2009)) And described signs in rats or mice after 6-hour inhalation administration of the saturated vapour (4 mg/L) (converted to a 4-hour equivalent value: 4.9 mg/L/4h) were dyspnea, hyperactivity, and prostration. (HSDB (2008)) From the above, the dose in oral administration is within a range of Category 2 in Guidance values, and that in dermal and inhalation administration corresponds to a range of Category 1 in Guidance values, but data are from List 2 and do not meet Decision Criteria 1b3) (OECDTG & GLP compliance test). Therefore, it was classified in Category 2 (central nervous system). In addition, in another 4-hour inhalation administration test to saturated vapour (4 mg/L) in rats, a recovery from observed depression immediately after administration was described. (IUCLID (2000)) It was judged to be transient from the description, therefore, it was classified in Category 3 (narcotic effects). |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible | - | - | - |
In a 28-day oral administration test in rats given at 10 to 300 mg/kg/day, no dose-related effects except transient and mild nasal irritation and adaptive changes in organ weights and clinical tests were observed up to the highest dose of 300 mg/kg/day (converted to a 90-day equivalent: 93.3 mg/kg/day). (IUCLID (2000)) In addition, in a 2-week dermal administration test in rabbits applied at 30 or 300 mg/kg/day, a slight transient body weight loss was observed, but neither dose-related effects in necropsy nor histopathological changes in liver and kidney were found. (HPVIS (2009)) Therefore, it corresponds to "Not classified" in an oral route, but it was classified as "Classification not possible" in specific target organ toxicity (repeated exposure) due to no data in other routes. |
| 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 | - | - | - |
It was classified as "Not classified" form 96-hour LC50 >100 mg/L for fish (Oryzias latipes) (Results of Eco-toxicity tests of chemicals conducted by Ministry of the Environment in Japan, 2009). |
| 11 | Hazardous to the aquatic environment （Long-term） | Not classified | - | - | - |
Reliable chronic toxicity data were not obtained. Due to not water-insoluble (water solubility: 21700 mg/L, PHYSPROP Database, 2012), and "Not classified" in acute toxicity, it was classified as "Not classified." |
| 12 | Hazardous to the ozone layer | Classification not possible | - | - | - |
This substance is not listed in Annexes to the Montreal Protocol. |
NOTES:
|
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * 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. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |
Updated date:
|
2017/3/17 Addition of Rationale for the classification |