Item | Information |
---|---|
CAS RN | 526-75-0 |
Chemical Name | 2.3-xylenol; 2,3-Dimethylphenol |
Substance ID | R01-B-029 |
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), (2), it was classified in Category 4. Besides, the category was changed from the previous classification by the use of the new information sources. [Evidence Data] (1) LD50 for rats: 562 mg/kg (REACH registration dossier (Access on August 2019)) (2) LD50 for rats: 562-790 mg/kg (NICNAS IMAP (Access on August 2019)) |
1 | Acute toxicity (Dermal) | Category 3 |
Danger |
H311 |
P302+P352
P361+P364 P280 P312 P321 P405 P501 |
[Rationale for the Classification] Based on (1), it was classified in Category 3. Besides, the category was changed from the previous classification by the use of the new information source. [Evidence Data] (1) LD50 for mice: 920 mg/kg (ACGIH (7th, 2019)) |
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. [Reference Data, etc.] (1) 4-hour inhalation exposure to the saturated vapor (0.0855 mg/L) did not result in mortality among exposed rats (HSDB (Access on June 2019)). |
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) and (2), it was classified in Category 1. Besides, since new data were obtained, the category was changed. [Evidence Data] (1) This substance is potentially corrosive to the skin and eyes (NICNAS IMAP (Access on August 2019)). (2) It was classified in "Skin Corr. 1B (H314)" in EU-CLP classification (EU CLP classification (Access on June 2019)). [Reference Data, etc.] (3) In an in vitro skin irritation test using the Human Dermal Epithelial Model (EpiDerm) according to OECD TG 439, this substance was classified as an irritant (REACH registration dossier (Access on July 2019)). |
3 | Serious eye damage/eye irritation | Category 1 |
Danger |
H318 |
P305+P351+P338
P280 P310 |
[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1. Besides, new data were obtained, the category was changed. [Evidence Data] (1) This substance was classified as Skin Corrosion (Category 1). (2) This substance is potentially corrosive to the skin and eyes (NICNAS IMAP (Access on August 2019)). [Reference Data, etc.] (3) It was classified as an irritant in an in vitro eye irritation test with MatTek EpiOcular, a human cornea-like model, according to the OECD TG 439 (REACH registration dossier (Access on July 2019)). |
4 | Respiratory sensitization | * |
- |
- | - |
[Rationale for the Classification] Classification not possible due to lack of data. |
4 | Skin sensitization | * |
- |
- | - |
[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) In a mouse local lymph node assay (LLNA), it was reported that the Stimulation Index (SI) was < 3 and this substance was negative for skin sensitization (NICNAS IMAP (Access on August 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] There is no result for a carcinogenicity test on this substance. Based on classification results by other organizations shown in (1), it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) In the classification results by domestic and international organizations, it was classified in A3 by ACGIH (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 a single oral dose study with rats, although signs of central nervous system effects were reported at 2,150 mg/kg (exceeding the range of Category 2) and above for this substance, these were considered to be due to severe irritation of the gastrointestinal tract (ACGIH (7th, 2019)). (3) 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 3,4-Dimethylphenol (3,4-xylenol) (CAS RN 95-65-8) 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 48-hour EC50 = 13.5605148 mg/L for crustacea (Daphnia magna) (AQUIRE, 2019, Devillers, 1988). |
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% (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. |
|