GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 93-15-2
Chemical Name 4-Allyl-1,2-dimethoxybenzene
Substance ID H28-B-13-METI, M-015B
Classification year (FY) FY2016
Ministry who conducted the classification Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE)
New/Revised Revised
Classification result in other fiscal year FY2006  
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

PHYSICAL HAZARDS
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
-
-
- -  Due to a flash point of 99 deg C (closed-cup, HSDB (Access on October 2016)), it corresponds to "Not classified."
7 Flammable solids Not applicable
-
-
- -  Liquid (GHS definition)
8 Self-reactive substances and mixtures Classification not possible
-
-
- -  There is an unsaturated bond (olefins) present in the molecule, but the classification is not possible due to no data.
9 Pyrophoric liquids Not classified
-
-
- -  Due to the information that it is stable to air, heat, and light (HSDB (Access on October 2016)), it is estimated that it does not ignite in contact with air at normal temperature.
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.

HEALTH HAZARDS
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
 Based on the LD50 value of 1,179 mg/kg (PATTY (6th, 2012)) for rats, this substance was classified in Category 4.
1 Acute toxicity (Dermal) Not classified
-
-
- -  Based on the LD50 value of > 2,025 mg/kg (PATTY (6th, 2012)) for rabbits, this substance was classified as "Not classified." The category was changed based on the new information.
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) Classification not possible
-
-
- -  Classification not possible due to lack of data.
2 Skin corrosion/irritation Not classified
-
-
- -  It is described that in a skin irritation test using rabbits, this substance is slightly irritating (PATTY (6th, 2012)). In addition, it is reported that this substance was not a skin irritant to rats and mice (NTP TR491 (2000)). From the above, this substance 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
 It is described that in an eye irritation test using rabbits, this substance is slightly irritating (PATTY (6th, 2012)). In addition, it is reported that this substance was not an eye irritant to rats and mice (NTP TR491 (2000)). From the above, this substance 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
-
-
- -  Classification not possible due to lack of data.
 Besides, it is reported that when this substance at 8% was applied to 25 volunteers in a maximization test, no sensitization was seen (HSDB (Access on October 2016)), but this was judged as inadequate data for use in classification.
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 data, a micronucleus test using peripheral blood of mice is negative and a DNA adduct test in the liver of mice is positive (NTP DB (Access on October 2016), IARC 101 (2013)). As for in vitro data, bacterial reverse mutation tests are negative, mammalian cell chromosomal aberration tests are negative and positive, and sister chromatid exchange tests in cultured mammalian cells are positive (NTP DB (Access on October 2016), NTP TR491 (2000), IARC 101 (2013)). However, there is a discrepancy between the descriptions of the results of the chromosomal aberration tests and sister chromatid exchange tests, so there is no validity to make a positive judgement. Positive results have been observed in the in vivo somatic cell genotoxicity tests, but there are no positive findings in the in vitro mutagenicity tests. Therefore, it was determined that the substance did not correspond to Category 2 in the GHS classification guidance for the Japanese Government.
6 Carcinogenicity Category 1B


Danger
H350 P308+P313
P201
P202
P280
P405
P501
 In 2-year carcinogenicity studies using rats and mice administered by gavage, in rats, increases in the incidences of liver tumors (hepatocellular adenoma, hepatocellular carcinoma and hepatocholangiocarcinoma) and of neuroendocrine tumors of the glandular stomach were observed in both sexes. In addition, in males, significant increases in malignant mesothelioma, adenoma of the kidney, mammary gland fibroadenoma and subcutaneous fibroma were observed. In mice, an increase in the incidence of liver tumors (hepatocellular adenoma, hepatocellular carcinoma, hepatoblastoma and hepatocholangiocarcinoma) was observed in both sexes. The neuroendocrine tumors of the glandular stomach in males were also considered to be the effects of administration (NTP TR491 (2000)). NTP classified the carcinogenicity of this substance as R since there is clear evidence of carcinogenicity in both rats and mice (NTP RoC (13th, 2014)). Likewise, IARC, with no carcinogenicity information on humans but adequate evidence in experimental animals, classified this substance in Group 2B (IARC 101 (2013)).
 From the above, this substance corresponds to Category 2 based on the classification result by IARC. However, as a result of considering the NTP data in detail, as expert judgment, it was judged that it is appropriate to classify this substance in Category 1B for this hazard class.
7 Reproductive toxicity Classification not possible
-
-
- -  Classification not possible due to lack of data.
8 Specific target organ toxicity - Single exposure Category 3 (Narcotic effects)


Warning
H336 P304+P340
P403+P233
P261
P271
P312
P405
P501
 There is no single exposure information on humans for this substance.
 As for experimental animals, it is reported that in single dose studies using rats, mice and rabbits dosed intraperitoneally or intravenously, this substance causes temporary sleep induction and loss of righting reflexes (PATTY (6th, 2012)). These are routes other than oral, percutaneous or inhalation, but it clearly shows narcotic effects. Therefore, this substance was classified in Category 3 (narcotic effects).
9 Specific target organ toxicity - Repeated exposure Category 2 (stomach, liver)


Warning
H373 P260
P314
P501
 There is no information on humans.
 As for experimental animals, in a 14-week repeated dose toxicity study using rats administered by gavage, an increase in platelet count, an increase in ALT and SDH (sorbitol dehydrogenase) which indicate liver damage, an increase in liver weights, adrenal gland cortical hypertrophy and cytoplasmic alteration in the submandibular glands were observed at 100 mg/kg/day (converted guidance value: 78 mg/kg/day) or more, which is equivalent to Category 2. In a 14-week repeated dose toxicity study using mice by gavage administration, decreases in cauda epididymis and testis weights were observed at 10 mg/kg/day (converted guidance value: 7.8 mg/kg/day) equivalent to Category 1, or above; an increase in liver weights and lesions of the glandular stomach (atrophy, degeneration, necrosis, edema, mitotic alteration, and cystic glands of the fundic region of the glandular stomach) were observed at 30 mg/kg/day (converted guidance value: 23 mg/kg/day) equivalent to Category 2, or above; and lower spermatozoal concentrations were observed at 100 mg/kg/day (converted guidance value: 78 mg/kg/day) (NTP TR491 (2000)).
 In a 105-week repeated dose toxicity study using rats by gavage administration, lesions of the liver (eosinophilic focus, mixed cell focus, hepatocyte hypertrophy and oval cell hyperplasia), lesions of the glandular stomach (neuroendocrine cell hyperplasia, atrophy) and cytoplasmic alteration of the submandibular salivary gland were observed at 37 mg/kg/day, equivalent to Category 2, or more, and lesions of the liver (hepatocyte necrosis and bile duct hyperplasia) were observed at 75 mg/kg/day or above. In a 105-week repeated dose toxicity study using mice by gavage administration, lesions of the liver (eosinophilic focus, oval cell hyperplasia, hepatocyte hypertrophy, etc.) and lesions of the glandular stomach (atrophy, hyperplasia, ectasia) were observed at 37 mg/kg/day, equivalent to Category 2, or more, and lesions of the liver (hepatocyte necrosis and bile duct hyperplasia) were observed at 75 mg/kg/day or more (NTP TR491 (2000)).
 Of the above, the testis was not considered to be a target organ because it was scant in histopathological changes and they were not seen in other studies. In addition, the adrenal gland cortex hypertrophy observed in rats was not observed in long-term studies and was considered to be an adaptability finding, so it was not considered to be an effect. The cytoplasmic alteration of the submandibular salivary gland was regarded as a secondary effect because it was thought that it is an effect caused by damage to the glandular stomach. Therefore, this substance was classified in Category 2 (stomach, liver).
10 Aspiration hazard Classification not possible
-
-
- -  Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS
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 96-hour LC50 = 14 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2003)), it was classified in Category 3.
11 Hazardous to the aquatic environment (Long-term) Not classified
-
-
- -  If chronic toxicity data are used, then it is classified as "Not classified" because it is rapidly degradable (a degradation rate by BOD: 89 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1984)), and its 21-day NOEC = 1.1 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2003)).
 If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" because its 96-hour LC50 = 14 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2003), but it is rapidly degradable (a degradation rate by BOD: 89 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1984)), and estimated to be a low bioaccumulation (log Kow = 3.03 (PHYSPROP Database,2009)).
 It was classified as "Not classified" from the above results.
12 Hazardous to the ozone layer Classification not possible
-
-
- -  No data available.


NOTE:
* 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.

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