Item | Information |
---|---|
CAS RN | 106-44-5 |
Chemical Name | p-Cresol |
Substance ID | m-nite-106-44-5_v1 |
Download of Excel format | Excel file |
Item | Information |
---|---|
Guidance used for the classification (External link) | To Guidance List |
UN GHS document (External link) | To UN GHS document |
FAQ(GHS classification results by the Japanese Government) | To FAQ |
List of Information Sources (Excel file) | List of Information Sources |
List of Definitions/Abbreviations | Definitions/Abbreviations |
Sample Label by MHLW (External link) | To Workplace Safety Site (MHLW) |
Sample SDS by MHLW (External link) | To Workplace Safety Site (MHLW) |
OECD/eChemPortal (External link) | To OECD/eChemPortal (External link) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
1 | Explosives | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
7 | Flammable solids | Classification not possible |
- |
- | - | No data available. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
8 | Self-reactive substances and mixtures | Not classified (Not applicable) |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
9 | Pyrophoric liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
10 | Pyrophoric solids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 555 deg C (ICSC (2008)). | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to solid (melting point <= 140 deg C) substances are not available. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified (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). | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
16 | Corrosive to metals | Classification not possible |
- |
- | - | It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
17 | Desensitized explosives | - |
- |
- | - | - | - | - |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Category 3 |
Danger |
H301 | P301+P310 P264 P270 P321 P330 P405 P501 |
There are 3 reports of LD50 values of 207 mg/kg (ATSDR (2008), NTP TR550 (2008), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), SIDS (2005), EHC 168 (1995)), 270 mg/kg (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)) and 1,800 mg/kg (ACGIH (7th, 2001)) for rats. According to the classification guidance for the Japanese Government, it was classified in Category 3 to which the most data (2 cases) corresponded. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
1 | Acute toxicity (Dermal) | Category 3 |
Danger |
H311 | P302+P352 P361+P364 P280 P312 P321 P405 P501 |
Based on reports of an LD50 value of 750 mg/kg for rats (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), EHC 168 (1995)) and of LD50 values of 300 mg/kg (NTP TR550 (2008), ATSDR (2008), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), SIDS (2005), EHC 168 (1995)) and 301 mg/kg (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)) for rabbits, it was classified in Category 3. |
FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
1 | Acute toxicity (Inhalation: Gases) | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
1 | Acute toxicity (Inhalation: Vapours) | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, there is a report of an LC50 value (1 hour) of >0.71 mg/L (=160 ppm) (converted 4-hour equivalent value: >0.355 mg/L) (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), SIDS (2005)) for rats. Since the LC50 value was higher than the saturated vapor concentration (1.49 mg/L=148 ppm), it was regarded as a mist. From this LC50 value, it was not possible to specify Category 2, Category 3, Category 4, or "Not classified." Therefore, it was classified as "Classification not possible." | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
2 | Skin corrosion/irritation | Category 1 |
Danger |
H314 | P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501 |
There is a report that after occlusive application of 0.5 mL of the undiluted liquid of this substance for 4 hours to rabbits, corrosivity (2/6 animals) was observed (EHC 168 (1995), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2005)). In another study, there is a report that after application of the undiluted liquid of this substance to rabbits, severe erythema and edema occurred within 24 hours and did not disappear within 72 hours (SIDS (2001)). From the above results, it was classified in Category 1. Besides, this substance was classified in "C; R34" in EU DSD classification and in "Skin Corr. 1B" in EU CLP classification. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
3 | Serious eye damage/eye irritation | Category 1 |
Danger |
H318 | P305+P351+P338 P280 P310 |
There is a report that after 0.1mL of the undiluted liquid of this substance was applied to rabbits, highly irritating effects on the conjunctiva, cornea and iris were observed and these did not disappear up to 72 hours after application (SIDS (2005)). Therefore, it was classified in Category 1. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
4 | Skin sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, there are reports that no sensitization reactions were observed in a skin sensitization test (modified Draize test) with guinea pigs (SIDS (2005), DFGOT Vol. 14 (2000)), and that no sensitization reactions were observed after applying 4% p-cresol dissolved in petrolatum to 25 volunteers (SIDS (2005)). However, since the test conditions and other details were unknown, the data was judged to be insufficient for classification, and the classification was revised. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, it was negative in a mouse dominant lethal test and a mouse bone marrow chromosomal aberration test (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), ATSDR (2008), DFGOT vol. 14 (2000), SIDS (2005)). As for in vitro, it was negative in a bacterial reverse mutation test, a mouse lymphoma test with cultured mammalian cells, and a sister chromatid exchange test with human cells, and weakly positive in a mammalian cell chromosome aberration test and an unscheduled DNA synthesis test with human peripheral blood lymphocytes (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), SIDS (2005), ATSDR (2008), DFGOT vol. 14 (2000), NTP DB (Access on July 2014)). From the above, although the in vitro chromosomal aberration test showed positive results, the in vivo test results were all negative. Therefore, this substance was judged not to be mutagenic in vivo. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
6 | Carcinogenicity | Category 2 |
Warning |
H351 | P308+P313 P201 P202 P280 P405 P501 |
Because it was classified as C by EPA (EPA (1991)), it was classified in Category 2. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
7 | Reproductive toxicity | Classification not possible |
- |
- | - | Effects on fertility were not observed in a two-generation reproductive toxicity study by the oral route (gavage) in rats (ATSDR (2008), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)). Besides, as for this study, it is described in SIDS (2005) that although no clear dose-dependent correlation was observed, there was an increase in stillbirth, therefore the NOAEL for the developmental toxicity could not be determined. In teratogenicity studies with rats and rabbits by the oral route, only marginal effects on fetuses (skeletal variations) were observed even at doses where maternal toxicities including death were observed (ATSDR (2008), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)). From the above, in the two-generation reproductive toxicity study with rats, although there were no clear dose-dependent effects, there was an increase in stillbirth and there is a report that the NOAEL for the developmental toxicity could not be determined. Therefore, it was classified as "Classification not possible." |
FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
8 | Specific target organ toxicity - Single exposure | Category 1 (central nervous system, respiratory organs, cardiovascular system, liver, kidney) |
Danger |
H370 | P308+P311 P260 P264 P270 P321 P405 P501 |
In humans, this substance showed respiratory tract irritation and caused corrosivity by ingestion. Inhalation of the vapor or aerosol might cause pulmonary edema. By inhalation, burning sensation, sore throat, cough, headache, nausea, vomiting, closeness and shortness of breath were observed, and by ingestion, nausea, vomiting, abdominal pain, shock/prostration, burning sensation, and effects on the central nervous system, cardiovascular system, lung, liver and kidney were observed, and at high concentrations, decreased consciousness was observed, resulting in death sometimes (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), ACGIH (7th, 2001)). As for experimental animals, mucosal irritation, neuromuscular excitation and convulsions, and hematuria (at very high concentrations) were reported for inhalation exposure to rats (SIDS (2005)). In addition, hypoactivity, salivation, incoordination, muscle twitches, tremors, convulsions, dyspnea, weakness, lethargy, coma and mortality, and as necropsy findings, inflammation of the gastrointestinal tract, hyperemia or hemorrhage of the lung, liver and kidney were reported for oral administration to mice or rats (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). These findings were observed within the range of guidance values corresponding to Category 1 or Category 2. From the above, it was classified in Category 1 (central nervous system, respiratory organs, cardiovascular system, liver, kidney). |
FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (central nervous system, cardiovascular system, kidney), Category 2 (respiratory organs, blood system, liver) |
Danger Warning |
H372 H373 |
P260 P264 P270 P314 P501 |
In humans, there are descriptions that 7 workers who were exposed to a vapor of a cresol mixture containing this substance (concentration unknown) by inhalation for 1.5 to 3 months developed headaches with nausea and vomiting, and 4 of them also developed elevated blood pressure, impaired kidney function, blood calcium imbalance and marked tremors (ACGIH (7th, 2001), DFGOT vol. 14 (2000), PATTY (6th, 2012)). As for experimental animals, in 28-day feeding studies of this substance in rats and mice, at doses corresponding to Category 2 (mice: 50-60 mg/kg/day (15.5-18.7 mg/kg/day (converted guidance value)), rats: 242-256 mg/kg/day (75.3-79.6 mg/kg/day (converted guidance value))), histological changes in the nasal cavity (hyperplasia of the respiratory epithelium, squamous metaplasia) were observed in both species, and increased relative liver weight and hypoplasia of the bone marrow were observed in rats, and findings of anemia tendency (decreases in erythrocyte counts and hemoglobin concentration), liver dysfunction (increases in serum AST and ALT), symptoms of the central nervous system (Lethargy, immobility, tremor, convulsions) were observed at the high dose corresponding to "Not classified" (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), SIDS (2005), ATSDR (2008)). Therefore, increased relative liver weight and hypoplasia of the bone marrow observed within the dose range of Category 2 were considered to be toxicologically significant, and the "liver" and the "hemal system" were added to the target organ. From the above, based on the findings in humans (mixture) and experimental animals (this substance: p-isomer), it was classified in Category 1 (central nervous system, cardiovascular system, kidney), Category 2 (respiratory organs, hemal system, liver). Besides, although it was classified based on the knowledge on experimental animals only in the previous classification, the classification result was reviewed in consideration of the consistency with the classification for other isomers and cresol mixtures this time. |
FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment Short term (Acute) | Category 2 |
- |
H401 | P273 P501 |
It was classified in Category 2 from 48-hour LC50 = 1.4 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2007)). | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
11 | Hazardous to the aquatic environment Long term (Chronic) | Category 3 |
- |
H412 | P273 P501 |
It was classified in Category 3 due to rapid degradability (a degradation rate by BOD = 80-95% (SIDS, 2003)), and 21-day NOEC = 0.52 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997), Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), Initial Risk Assessment (NITE, CERI, NEDO, 2007)). | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
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