Item | Information |
---|---|
CAS RN | 95-65-8 |
Chemical Name | 3,4-xylenol; 3,4-Dimethylphenol |
Substance ID | R01-B-026 |
Classification year (FY) | FY2019 |
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 | FY2008 |
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) | 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 | * |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)." |
2 | Flammable gases | * |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." |
3 | Aerosols | * |
- |
- | - | Not aerosol products. It was classified as "Not classified (Not applicable)." |
4 | Oxidizing gases | * |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." |
5 | Gases under pressure | * |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." |
6 | Flammable liquids | * |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." |
7 | Flammable solids | * |
- |
- | - | No data available. Besides, there is information that it is a flammable solid, and a flash point is 80-95 deg C for a liquid after melting (Hommel (1991)). |
8 | Self-reactive substances and mixtures | * |
- |
- | - | There are no chemical groups associated with explosive or self-reactive properties present in the molecule. It was classified as "Not classified (Not applicable)." |
9 | Pyrophoric liquids | * |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." |
10 | Pyrophoric solids | * |
- |
- | - | It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of > 500 deg C (GESTIS (Access on July 2019)). |
11 | Self-heating substances and mixtures | * |
- |
- | - | Classification is not possible because 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 | * |
- |
- | - | The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). It was classified as "Not classified (Not applicable)." |
13 | Oxidizing liquids | * |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." |
14 | Oxidizing solids | * |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. It was classified as "Not classified (Not applicable)." |
15 | Organic peroxides | * |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)." |
16 | Corrosive to metals | * |
- |
- | - | Classification is not possible because test methods applicable to solid substances are not available. |
17 | Desensitized explosives | * |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified." |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Category 4 |
Warning |
H302 |
P301+P312
P264 P270 P330 P501 |
[Rationale for the Classification] Based on (1), it was classified in Category 4. [Evidence Data] (1) LD50 for rats: 727-1,600 mg/kg (NICNAS IMAP (Access on August 2019)) [Reference Data, etc.] (2) LD50 for mice: 400 mg/kg (HSDB (Access on June 2019)) (3) LD50 for rabbits: 800 mg/kg (HSDB (Access on June 2019)) |
1 | Acute toxicity (Dermal) | * |
- |
- | - |
[Rationale for the Classification] Classification not possible due to lack of data. |
1 | Acute toxicity (Inhalation: Gases) | * |
- |
- | - |
[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)." |
1 | Acute toxicity (Inhalation: Vapours) | * |
- |
- | - |
[Rationale for the Classification] Classification not possible due to lack of data. |
1 | Acute toxicity (Inhalation: Dusts and mists) | * |
- |
- | - |
[Rationale for the Classification] Classification not possible due to lack of data. |
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 |
[Rationale for the Classification] Based on (1), it was classified in Category 1. Besides, since new data was obtained, the category was changed. [Evidence Data] (1) A study in guinea pigs reported this substance at doses of 0.25-1 mg/kg, to be severely irritating to the skin, with moderate edema developing within 24 hours, in addition to necrosis and eschar formation (NICNAS IMAP (Access on August 2019)). |
3 | Serious eye damage/eye irritation | Category 1 |
Danger |
H318 |
P305+P351+P338
P280 P310 |
[Rationale for the Classification] Based on (1)-(3), it was classified in Category 1. Besides, since new data were obtained, the category was changed. [Evidence Data] (1) In an eye irritation test in which several dry crystals of this substance were applied to one rabbit, slight to moderate erythema, edema and corneal opacity were found after 1 hour, and some remaining effects were observed after 14 days (ACGIH (7th, 2019)). (2) Eye irritation studies with rabbits report permanent damage following administration of this chemical (NICNAS IMAP (Access on August 2019)) (3) This substance was classified as Skin Corrosion (Category 1). |
4 | Respiratory sensitization | * |
- |
- | - |
[Rationale for the Classification] Classification not possible due to lack of data. |
4 | Skin sensitization | Category 1 |
Warning |
H317 |
P302+P352
P333+P313 P362+P364 P261 P272 P280 P321 P501 |
[Rationale for the Classification] Based on (1), it was classified in Category 1. Besides, since new data was obtained, the category was changed. [Evidence Data] (1) It is reported that a mouse local lymph node assay showed an SI value of 10, and this substance was positive for skin sensitization (ACGIH (7th, 2019)). [Reference Data, etc.] (2) For all dimethylphenol isomers, including this substance, and mixtures thereof, ACGIH classified them as skin sensitizers (DSEN) (ACGIH (7th, 2019)). |
5 | Germ cell mutagenicity | * |
- |
- | - |
[Rationale for the Classification] There are no in vivo data. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) As for in vitro, it is reported to be negative in a bacterial reverse mutation test (ACGIH (7th, 2019), NICNAS IMAP (Access on August 2019), NTP DB (Access on June 2019)). |
6 | Carcinogenicity | Category 2 |
Warning |
H351 |
P308+P313
P201 P202 P280 P405 P501 |
[Rationale for the Classification] Based on classification results by other organizations in (1) and the report of (2), it was classified in Category 2. Since new data were obtained, the category was changed from the previous classification. [Evidence Data] (1) In the classification results by domestic and international organizations, it was classified in A3 by ACGIH (ACGIH (7th, 2019)). (2) In a test in which this substance was dermally applied to mice for 28 weeks, it is reported to be carcinogenic to the skin (ACGIH (7th, 2019)). |
7 | Reproductive toxicity | * |
- |
- | - |
[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) In a combined oral repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats by oral gavage of a mixture of six dimethylphenol (xylenol) isomers, including this substance, although increases in relative weights of the kidney, liver and ovaries were observed as general toxicity, no apparent reproductive effects were observed (ACGIH (7th, 2019), NICNAS IMAP (Access on August 2019)). |
8 | Specific target organ toxicity - Single exposure | * |
- |
- | - |
[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) There is one case report of an individual who ingested 250 mL of a disinfectant product that was reported as a mixture of six isomeric dimethylphenols (xylenol) including this substance, in an alcoholic, anionic base. The individual exhibited gastrointestinal effects (active bowel sounds, nausea and vomiting) and central nervous system depression (barely rousable) that progressed to metabolic acidosis and heart and cardiovascular changes (hypotension with reduced cardiac output), and then death about 16 hours following the ingestion. The lethal dosage of dimethylphenol (xylenol) ingestion in this case report was not reported (ACGIH (7th, 2019)). (2) In experimental animals, it is reported that sublethal signs of toxicity for xylenol compounds, including this substance, included dyspnea, loss of motor coordination and spasms, but the details are not available (NICNAS IMAP (Access on August 2019)). |
9 | Specific target organ toxicity - Repeated exposure | * |
- |
- | - |
[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) As a result of oral administration of this substance for 8 months to rats, decreased body weight and effects on blood pressure, the liver, spleen, heart and lungs are reported at 14 mg/kg/day (within the range of Category 2), however, as these effects have not been replicated in more recent studies conducted at higher dosages, these findings are not considered reliable (ACGIH (7th, 2019)). (2) Regarding dimethylphenol (xylenol), ACGIH considers that the 6 isomers and the mixed isomer substance are similar in toxicity, and sets a common TLV after conversion to an inhalation exposure based on the toxicity information of 2,4-dimethylphenol (2,4-xylenol) (CAS RN 105-67-9) (NOAEL based on changes in hematological parameters observed in a 90-day oral dose study with mice at 250 mg/kg/day (exceeding the range of Category 2) = 50 mg/kg/day) (ACGIH (7th, 2019)). |
10 | Aspiration hazard | * |
- |
- | - |
[Rationale for the Classification] 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 Short term (Acute) | Category 3 |
- |
H402 |
P273
P501 |
It was classified in Category 3 from 96-hour LC50 = 14 mg/L for fish (Pimephales promelas) (AQUIRE, 2008, Mattson, 1976). |
11 | Hazardous to the aquatic environment Long term (Chronic) | Category 3 |
- |
H412 |
P273
P501 |
Reliable chronic toxicity data were not obtained. It was classified in Category 3 because it is not rapidly degradable (a degradation rate by BOD: 44%, a degradation rate by TOC: 49% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1976)), and it was classified in Category 3 in acute toxicity. |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
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