| Item | Information |
|---|---|
| CAS RN | 25265-77-4 |
| Chemical Name | 2,2,4-Trimethylpentane-1,3-diol monoisobutyrate [Texanol] |
| Substance ID | H29-A-027 |
| Classification year (FY) | FY2017 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | New |
| Classification result in other fiscal year | |
| Download of Excel format | Excel file |
| Item | Information |
|---|---|
| Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| UN GHS document (External link) | UN GHS document |
| Definitions/Abbreviations (Excel file) | Definitions/Abbreviations |
| Model Label by MHLW (External link) | |
| Model SDS by MHLW (External link) | |
| OECD/eChemPortal (External link) | eChemPortal |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
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 |
- |
- | - | Liquid (GHS definition) |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 5 | Gases under pressure | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 6 | Flammable liquids | Not classified |
- |
- | - | A flash point is 122 deg C (closed cup) (GESTIS (Access on September 2017)). |
| 7 | Flammable solids | Not applicable |
- |
- | - | Liquid (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 estimated that it does not ignite at normal temperatures from an autoignition temperature of 393 deg C (GESTIS (Access on September 2017)). |
| 10 | Pyrophoric solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to liquid substances are not available. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable |
- |
- | - | The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No data available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | Based on the reports of LD50 values of > 3,200 mg/kg (SIDS (2002)), 6,517 mg/kg (SIDS (2002), PATTY (6th, 2012)) for rats, this substance was classified as "Not classified." |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | There is a report of an LD50 value of > 16 mL/kg (> 15,200 mg/kg) (SIDS (2002), PATTY (6th, 2012)) for rabbits, and it corresponds to "Not classified." There is a report of an LD50 value of > 20 mL/kg (> 19,000 mg/kg) (SIDS (2002), PATTY (6th, 2012)) for guinea pigs, and it corresponds to "Not classified." From the above, this substance was classified as "Not classified." |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Not classified |
- |
- | - | Based on a report of > 3.55 mg/L (converted 4-hour equivalent value: > 5.33 mg/L) (SIDS (2002), PATTY (6th, 2012)) as the LC50 value for rats in a 6-hour inhalation exposure test, it was classified as "Not classified." Besides, the exposure concentration is higher than the saturated vapor pressure concentration (12.9 ppm (0.114 mg/L)), so the reference value in the unit of mg/L as mist was applied. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | There is a report that in a skin irritation test (according to EU Method B.4) with rabbits, it showed mild irritation when this substance was applied for 4 hours (ECHA registration information (Access on December 2017)). In addition, there is a description that in two skin irritation tests with guinea pigs, mild irritation was shown despite long-time application in both (SIDS (2002)). Therefore, it was judged that this substance has mild irritation, and it was classified as "Not classified" (Category 3 in UN GHS classification). |
| 3 | Serious eye damage/eye irritation | Category 2B |
Warning |
H320 |
P305+P351+P338
P337+P313 P264 |
There is a description that in an eye irritation test (similar to OECD TG 405) with rabbits, a grade 2 redness of the conjunctiva was produced 24 hours after application, the maximum score in an unwashed eye was 4 (maximum 110), and it was a slight to moderate eye irritant (SIDS (2002), PATTY (6th, 2012)). In addition, there is a description that in another study with rabbits, mild irritation was observed (ECHA registration information (Access on December 2017)). Therefore, it was judged that it has mild irritancy, so it was classified in Category 2B. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | There is a description that in a skin sensitization test (according to OECD TG 406) with guinea pigs, no sensitization was observed (SIDS (2002), PATTY (6th, 2012)). However, it was classified as "Classification not possible" because no information on humans was obtained. |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | As for in vivo, a micronucleus test with mouse bone marrow cells was negative, and as for in vitro, a bacterial reverse mutation test was negative (SIDS (2002), PATTY (6th, 2012)). From the above, it was classified as "Classification not possible." |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, effects on the liver (increased liver weight, centrilobular hypertrophy of hepatocytes) at or above 300 mg/kg/day in maternal animals were observed, but no reproductive or developmental effect was observed at up to 1,000 mg/kg, which was the limit dose (PATTY (6th, 2012), SIDS (2002)). However, it is difficult to classify it as "Not classified" with only this result since this test is a screening test, and no other data are available for the classification. Therefore, it was classified as "Classification not possible." |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | Classification not possible due to lack of data. In humans, among painters reporting feelings of discomfort from the use of water-based paints, as temporary health effects, decreased vital capacities, increased urine volumes and increased mean corpuscular volumes were observed. Although this substance was detected in the air sample collected in the respiration zone of the workers, the study population was small, so it was evaluated that it was impossible to derive a conclusion from this research result (PATTY (6th, 2012)). Therefore, this information was not adopted as evidence. As for experimental animals, there is a report that in a single-oral dose test with rats, slight transient weakness, rough coat, vasodilation, and labored breathing were observed at 3,200 mg/kg, which is above Category 2 (PATTY (6th, 2012)). However, the target organs could not be specified by these effects. It was classified as "Classification not possible" due to no other information. |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - |
There is no information in humans. As for experimental animals, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, salivation (due to the taste of the test substance) and an increase in liver weight at or above 100 mg/kg/day (converted guidance value: 44-57 mg/kg/day) within a guidance value range of Category 2, centrilobular hypertrophy and eosinophilia (degeneration of ground-glass appearance) of the hepatocytes in the liver, and hyaline droplets in the kidney (males only) at or above 300 mg/kg/day (converted guidance value: 133-170 mg/kg/day) greater than a guidance value range of Category 2, and an increase in kidney weight (males only) at 1,000 mg/kg/day (converted guidance value: 444-567 mg/kg/day) were observed. The findings of the liver in this study are considered to be associated with increased metabolism, and the findings of the kidney are considered to be unique to male rats (SIDS (2002)). From the above, no effect to be the evidence of the classification was observed, so it corresponds to "Not classified" in the oral route. However, it was classified as "Classification not possible" because no data on effects of other routes are available. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, the kinematic viscosity is calculated to be 13.58 mm2/sec (25/20 deg C) from the numerical data (Viscosity: 12.9 mPa*s (25 deg C), density: 0.95 g/cm3 (20 deg C)) listed on GESTIS (Access on August 2017). |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 3 |
- |
H402 |
P273
P501 |
From 72-hour EC50 (area method) = 18.4 mg/L for algae (Pseudokirchneriella subcapitata) (OECD SIDS: 1994), it was classified in Category 3. |
| 11 | Hazardous to the aquatic environment (Long-term) | Not classified |
- |
- | - | Due to being rapidly degradable (BioWin), no bioaccumulation (LogPow: 3 (SRC PhysProp Database (2017))), and 72-hour NOEC (area method) = 3.28 mg/L for algae (Pseudokirchneriella subcapitata) (OECD SIDS: 1994), it was classified as "Not classified." |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
|
* 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. |