GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTES:
Updated date:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS number | 57018-52-7 |
| Chemical name | 1-tert-Butoxy-2-propanol |
| Substance ID | 23A5173 |
| 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 44 degrees C [closed cup] (MSDS (Sigma-Aldrich) (Access on Dec. 2011)), 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 | Not classified | - | - | - | It is conceivable that it does not ignite at normal temperatures from an ignition point of 373 degrees C (ICSC (2006)). |
| 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 applicable | - | - | - | Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
| 13 | Oxidizing liquids | Not applicable | - | - | - | An organic compound does not contain fluorine or chlorine but contains oxygen which is not chemically bonded to elements other than carbon or hydrogen. |
| 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 | - | - | - | From an LD50 value of 3771 mg/kg for rats (PATTY (5th, 2001)), it was classified as "Not classified" in JIS classification (corresponding to Category 5 in UN GHS classification). |
| 1 | Acute toxicity （Dermal） | Not classified | - | - | - | From an LD50 value of >2000 mg/kg and no deaths at 2000 mg/kg in rabbits (PATTY (5th, 2001)), it was classified as "Not classified." |
| 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 cannot be determined only from a reported LC50 value of >500 ppm in a 4-hour exposure to rats (PATTY (5th, 2001)). Besides, a reference value of gasses as vapour with hardly included mist was applied because the test concentration (up to 550 ppm) is lower than 90 % of the saturated vapour pressure concentration (6184 ppm). |
| 1 | Acute toxicity （Inhalation: Dusts and mists） | Classification not possible | - | - | - | No data. |
| 2 | Skin corrosion/irritation | Not classified | - | - | - |
In an occlusive primary dermal irritation test applied to rabbit skin for 24 hours, transient and slight erythema and desquamation were observed in a 7-day observation period. But from the basis of the Primary Dermal Irritation Index of 0.6 (a maximal score of 8) (IARC 88 (2006)), it was classified as "Not classified." Besides, "slight skin irritation potential" was described from this result (IARC 88 (2006)). |
| 3 | Serious eye damage/eye irritation | Category 2 |  |
H319 |
P305+P351+P338 P337+P313 P264 P280 |
In a test applied 0.1 mL of undiluted test substance to rabbit eyes, corneal opacity reversed after 13 days except 1 out of 6 animals and other transient signs of redness, chemosis, and discharge, and irritation indices after 13 days of slight as below 10 (the highest score 110) were observed. But, there is the information that it should be considered as "a severe eye irritant" because corneal opacity remained by the end of the 13-day observation period in 1 animal (PATTY (5th, 2001)). Therefore, it was classified in Category 2. Besides, it is classified in Xi; R41 in EU classification (EC-JRC (ESIS) (Access on Dec. 2011)). |
| 4 | Respiratory sensitization | Classification not possible | - | - | - | No data. |
| 4 | Skin sensitization | Not classified | - | - | - | On the basis that a skin sensitization test using guinea pigs (Maximization method, OECD TG406) reported "no sensitization reaction" (PATTY (5th, 2001)), it was classified as "Not classified." |
| 5 | Germ cell mutagenicity | Classification not possible | - | - | - |
A weakly positive result in a micronucleus test using the peripheral blood after a 3-month inhalation exposure in mice (an in vivo somatic cell mutagenicity test) (NTP DB (Access on Dec. 2011) is not considered as a positive due to less biological significance. And due to no other in vivo test data, it was classified as "Classification not possible." Besides, as in vitro tests, an Ames test reported a positive (NTP DB (Access on Dec. 2011)), a chromosomal aberration test using CHO cells or human peripheral blood lymphocytes reported a negative (NTP DB (Access on Dec. 2011), ECETOC TR 95 (2005)), and a gene mutation test using L5178Y mouse lymphoma cells reported a negative (ECETOC TR 95 (2005)). |
| 6 | Carcinogenicity | Classification not possible | - | - | - |
From being classified in Group 3 in an IARC carcinogenicity assessment (IARC 88 (2006)), it was classified as "Classification not possible." Besides, in a carcinogenicity test by 2-year inhalation exposure to rats and mice, male rats showed marginally increased incidences of renal tubule and liver neoplasms regarded as equivocal evidence. But females did not show evidence of carcinogenicity. In addition, clear evidence of carcinogenicity from increased incidences of liver neoplasms in both male and female mice was reported. (NTP TR 515 (2004)). |
| 7 | Reproductive toxicity | Not classified | - | - | - |
In a 1-generation oral administration reproductive test, parent animals only showed clinical signs of salvation after dosing in middle or high dose groups but show neither deaths nor apparent systemic effects. As reproductive effects, lower birth body weights and a slight decrease in postnatal survival in offspring of maternal animals in the high-dose group were shown, but all of other prameters of litters and offsprings were normal. (ECETOC TR 95 (2005)). Furthermore, in a developmental toxicity test by inhalation exposure to rats and rabbits during an organogenetic period, fetal toxicity or adverse effects on development of the offspring were not observed in both animal species, but increased liver weight in 2 groups of higher dose in rats were observed as general toxicity in parent animals (IARC 88 (2006)). Because neither adverse effects on sexual function and fertility nor adverse effects on development were not observed in the 1-generation reproductive test from the above result, it was classified as "Not classified." |
| 8 | Specific target organ toxicity - Single exposure | Category 3 （Narcotic effects） | |
H336 |
P304+P340 P403+P233 P261 P271 P312 P405 P501 |
Because in acute oral toxicity test in rats (doses: 2239 to 4467 mg/kg, an LD50 value: 3371 mg/kg), signs of lethargy, ataxia, prostration, and irregular breathing were observed in all animals (PATTY (5th, 2001)), it was classified in Category 3 (narcotic effects). Besides, because neither deaths nor toxic signs nor effects on body weights were observed in dermal administration of 2000 mg/kg to rabbits (PATTY (5th, 2001)), it was regarded as corresponding to "Not classified" in a dermal route. On the other hand, furhter details of reported mild hepatic extramedullary hematopoiesis in 2 out of 5 animals in both males and females observed in 4-hour inhalation exposure of 2.68 mg/L to rats were unknown. (PATTY (5th, 2001)). |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible | - | - | - |
Accumulation of hyaline droplets and nephropathy with an increased alpha-2-u-globulin concentration in male rats observed in a 14-week inhalation exposure test in rats and mice (vapour; 75, 150, 300, 600, 1200 ppm) (NTP TR 515 (2004)) were not used as bases for classification because that, which is alpha-2-u-globulin nephropathy, is specific for male rats and is considered to be inapplicable to human. Adverse effects in both rats and mice in a range of Guidance values were not observed in findings above the 14-week inhalation exposure test. And another 13-week inhalation exposure test using rats reported a NOAEL of 3.843 mg/L above the upper limit (1 mg/L) of Guidance values. (PATTY (5th, 2001)) From the above, it corresponds to "Not classified" in an inhalation route. But it was classified as "Classification not possible" in specific target organ toxicity (repeated exposures) because judgments on effects in other routes (inhalation, dermal) are not possible due to no data. |
| 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） | 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:
|
2016/11/16 Created |