NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	83-67-0
Chemical Name	Theobromine; 2,6-Dihydroxy-3,7-dimethylpurine
Substance ID	m-nite-83-67-0_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

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)

PHYSICAL HAZARDS

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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen which is chemically bonded only to carbon or hydrogen.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

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 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on the rat LD50 value of 950 mg/kg bw (IARC 51 (1991)), the substance was classified into Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	The substance was classified as Category 2 based on the positive results in the bone marrow micronucleus test by oral administration to Chinese hamster (in vivo mutagenicity test in somatic cells) (IARC 51 (1991)). As relevant information, negative results in the dominant lethal tests (in vivo inheritable mutagenicity test in germ cells) by oral administration to rats and by intraperitoneal administration to mice (IARC 51 (1991)), negative result in the bone marrow chromosome aberration test (in vivo mutagenicity test in somatic cells) by oral administration to Chinese hamster and positive result in the bone marrow sister chromatid exchange test (in vivo genotoxicity test in somatic cells) by oral administration to Chinese hamster, were reported (IARC 51 (1991)). As for in vitro studies, negative results in the Ames test, positive result in the chromosome aberration test using human lymphocytes but negative using Chinese hamster cells, were reported (IARC 51 (1991)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	The classification was concluded as "Classification not possible" because the substance was classified as "Group 3" in the IARC assessment (IARC 51 (1991)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	In the reproductive study in mice by dietary administration from one week before mating, adverse effects were observed in at least one or more reproductive parameters, and the proportion of the number of live birth per pregnant parent was decreased compared with the control group. The cross-over mating trial demonstrated severely impaired fertility in females and an increase in the incidence of abnormal spermatozoa (NTP Report # RACB83073 (1984)). In the intraperitoneal injection study using pregnant mice during the organogenetic period, the increase in the occurrence of malformation such as cleft palate and ectrodactyly was reported. In the oral administration study using rabbits during the organogenetic period, malformations were reported (IARC 51 (1991)). The effects on parental fertility or development of offspring mentioned above were detected in the middle dose group at which the general toxicity to parental animals was not revealed. Therefore, the substance was classified as Category 1B. As relevant information, there was the 3-generation study in rats by oral administration of the substance in cocoa, in which adverse effects on reproduction were not seen (IARC 51 (1991)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (thymus)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	It was reported that oral administration to rats at the dose range of 250 - 300 mg/kg bw caused complete thymic atrophy and the thymus was identified as the target organ (IARC 51 (1991)). Since the administration dose levels of 250 - 300 mg/kg corresponded to Category 1 of the guidance values, the substance was classified as Category 1 (thymus).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In the 90-day feeding study in rats, the only changes were suppression of body weight gain and reduction in testicular weight at the high dose level (250 mg/kg/day), and no pathological and hematological changes were observed (IARC 51 (1991)). Moreover, it was also reported that severe testicular atrophy was observed in the feeding studies in rats for 28 days and 64 weeks at the dietary concentrations of 0.8% (converted dose level as that of 90-day study: 249 mg/kg/day) and 0.5% (converted dose level as that of 90-day study: 250 mg/kg/day), respectively (IARC 51 (1991)). But, these findings revealed at high doses beyond the range of the guidance values. Thus, the classification category was considered equivalent to the "Not classified" category, however, the classification for specific target organ toxicity (repeated exposure) was concluded as "Classification not possible" due to no data for the other routes.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

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)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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