GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 140-66-9 |
| Chemical Name | 4-(2,4,4-Trimethylpentan-2-yl)phenol |
| Substance ID | H29-B-028 |
| Classification year (FY) | FY2017 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | Revised |
| Classification result in other fiscal year | FY2009 |
| Download of Excel format | Excel file |
REFERENCE INFORMATION
| 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) | 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 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 |
- |
- | - | Solid (GHS definition). |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | Solid (GHS definition). |
| 5 | Gases under pressure | Not applicable |
- |
- | - | Solid (GHS definition). |
| 6 | Flammable liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 7 | Flammable solids | Classification not possible |
- |
- | - | No data available. |
| 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 |
- |
- | - | Solid (GHS definition). |
| 10 | Pyrophoric solids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 410 deg C (GESTIS (Access on June 2017)). |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to solid (melting point <= 140 deg C) 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 |
- |
- | - | Solid (GHS definition). |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not 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 a reported LD50 value for rats of > 2,000 mg/kg (SIDS (2005)), it was classified as "Not classified." Besides, the information of 4,600 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)) used in the previous classification was from RTECS, the information source listed in List 3, the original source could not be obtained, and the details could not be confirmed. Therefore, this information was not adopted. |
| 1 | Acute toxicity (Dermal) | Category 4 |
 Warning |
H312 |
P302+P352
P362+P364 P280 P312 P321 P501 |
Based on a reported LD50 value for rabbits of 1,880 mg/kg (SIDS (2005)), it was classified in Category 4. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, it is reported that the LC100 value was not more than 116 mg/L (converted 4-hour equivalent value: 29 mg/L) in a test in which rats were exposed by inhalation for one hour to aerosols of this substance of 89% purity (SIDS (2005)). |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | As for humans, this substance was described to be slightly irritating to the skin (SIDS (2005)). In a skin irritation test with rabbits (following OECD TG 404), it was reported that this substance was mildly irritating to the skin (SIDS (2005)). Therefore, this substance was classified as "Not classified" (Category 3 in the UN GHS classification). Besides, this substance was classified as Skin Irrit. 2 in the EU CLP classification (ECHA CL Inventory (Access on June 2017)). |
| 3 | Serious eye damage/eye irritation | Category 2A |
Warning |
H319 |
P305+P351+P338
P337+P313 P264 P280 |
As for humans, this substance was described to be highly irritating to the eyes (SIDS (2005)). An eye irritation test with rabbits (following OECD TG 405) revealed corneal opacity, iridial inflammation, severe conjunctival irritation, etc., the test score after 24 hours was 63.0. However, there is no information that the symptoms were irreversible (SIDS (2005)). Therefore, this substance was classified in Category 2A. Besides, this substance has been classified as Eye Dam. 1 in the EU CLP classification (ECHA CL Inventory (Access on June 2017)). |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | This substance was reported to be negative in a sensitization test with guinea pigs (following OECD TG 406) (SIDS (2005)). However, the result comes from one test only, and details such as the response rate in the positive controls are unknown. Therefore, this substance was classified as "Classification not possible." |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. There is no in vivo data. As for in vitro data, this substance was negative in bacterial reverse mutation tests and a chromosome aberration test with cultured mammalian cells (JECDB (Access on June 2017), SIDS (2005)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 7 | Reproductive toxicity | Category 2 |
 Warning |
H361 |
P308+P313
P201 P202 P280 P405 P501 |
A reproduction/developmental toxicity screening test with rats dosed by gavage revealed decreases in the conception rate and the implantation rate, prolonged duration of pregnancy, and developmental delay at 500 mg/kg/day. However, as this dosage caused a markedly high death rate of 54% in the dams (13 cases out of 24), the reproductive/developmental effects were considered to be secondary effects (SIDS (2005)). It is also reported that slight delays were observed in the days of age of vaginal opening and preputial separation in the pups in a two-generation study with rats dosed by feeding (Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)), and that a delay in sexual maturation and changes in the weights of male genetic organs thought to be associated with reduced body weights were observed in a study in which neonatal rats were dosed by gavage on postnatal days 1-5 (Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)). However, these effects were minor and difficult to be adopted as rationale for classification. Meanwhile, It is also reported that increased post-implantation embryo-fetal deaths were observed at the doses with maternal toxicity (reduced body-weight gain and reduced food consumption) (31.3 mg/kg/day or higher) in a developmental toxicity study in which pregnant rats were dosed orally during early pregnancy (days 0-8 of pregnancy) (Catalog of Teratogenic Agents, 11th ed.: Harazono, A. and Ema, M. (2001): Toxicol. Lett., 119, 79-84 (primary source confirmed)). Therefore, this substance was classified in Category 2 on the basis of increased embryo-fetal deaths at the doses with maternal toxicity. |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | Classification not possible due to lack of data. In the previous classification, this substance was classified in Category 3 (narcotic effects) on the basis of the information from IUCLID (2000) that mild sedation and ataxia were observed in an acute oral toxicity test in rats. However, since the information of IUCLID was not available and the details were unknown, it was not adopted. As there is no other information that provides a basis for classification, this substance was classified as "Classification not possible." Besides, it is stated in the ECHA registration dossier (Access on July 2017) that, in a single oral dose test in rats, ruffled fur, crouched posture, slight sedation and ataxia, diarrhea, diuresis, prone position, hypothermia, cyanosis, labored breathing, staggering, and trembling were observed 30 minutes after administration at or above 3,160 mg/kg exceeding the range of Category 2, and that dissection of surviving animals showed hyperemia of the small intestine; swelling of the gastric mucosa; and fusion of the liver, stomach, and spleen with the peritoneum. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 2 (kidney) |
Warning |
H373 |
P260
P314 P501 |
No information on humans is available. As for experimental animals, in a 28-day repeated oral dose toxicity test with rats dosed by gavage, salivation and low A/G ratios were observed at and above 70 mg/kg/day (converted guidance value: 21.8 mg/kg/day), which is within the guidance value range for Category 2; reduced body-weight gain, increased sodium, increased urea nitrogen and triglyceride, increased urine volume, decreased urine specific gravity, changes in urine electrolyte levels, increased kidney and liver weights, regeneration changes in the renal tubular epithelium, etc. were observed at 300 mg/kg/day (converted guidance value: 93.3 mg/kg/day) (JECDB (Access on June 2017), Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003), SIDS (2005)). In addition, it is reported that in a 29-day repeated oral dose toxicity test with rats dosed by gavage, basophilic epithelium with mitotic figures was observed in proximal tubules in the kidney at and above 150 mg/kg/day (converted guidance value: 46.7 mg/kg/day), which is within the guidance value range for Category 2, and that increased kidney and liver weights and centrilobular hepatocyte enlargement (an adaptive response related to the metabolism of the test substance) were observed at 250 mg/kg/day (converted guidance value: 77.8 mg/kg/day) (SIDS (2005)). From the above, although effects were observed in the kidney and liver, the liver was not regarded as a target organ because the effect on the liver was considered to be an adaptive response related to test-substance metabolism. Therefore, this substance was classified in Category 2 (kidney). The classification of this substance was changed as the finding in the liver was considered to be an adaptive response. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 1 |
 Warning |
H400 |
P273
P391 P501 |
From 96-hour LC50 = 0.0479 mg/L for crustacea (Americamysis bahia) (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003)), it was classified in Category 1. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 1 |
Warning |
H410 |
P273
P391 P501 |
Due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 0% (J-CHECK, 1978)), and 60-day NOEL = 0.0061 mg/L for fish (Oncorhynchus mykiss) (OECD SIDS: 1995), it was classified in Category 1. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* 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. |