NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	121-33-5
Chemical Name	Vanillin
Substance ID	m-nite-121-33-5_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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2012	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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of > 400 deg C (ICSC (2009)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2012	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).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2012	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.	FY2012	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)	Not classified	- -	-	-	There are multiple LD50 values for rats, and based on the data (3,978 mg/kg and 4,200 mg/kg) (SIDS (1996)) from the two tests that were performed according to the former guideline internationally approved (OECD TG 401), it was classified as "Not classified" in the Classification JIS (Category 5 in UN GHS classification).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" because the administration of 2,000 mg/kg to rats caused no death, and an LD50 value was >= 2,000 mg/kg (OECD TG 402, GLP) (SIDS (1996)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Because it is reported that 2-hour exposure to 41.7 mg/m3 (the saturated vapour pressure concentration) (converted 4-hour equivalent value: 0.021 mg/L) caused no death in rats (IUCLID (2000)), an LC50 value was estimated to be 0.021 mg/L/4 hours or above, but the category cannot be determined. Therefore, the classification is not possible.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Not classified	- -	-	-	It was classified as "Not classified" because there was no irritation in a skin irritation test in which this substance moistened with water was applied to six rabbits for 24 hours (SIDS (1996)). And also in humans, it is reported that in an occlusive application test in which undiluted this substance was applied to 30 workers including ones with dermatitis and 15 healthy controls, no irritation was observed, and it was assessed to be negative (SIDS (1996)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	In an eye irritation test in which 55 mg of this substance was applied to six rabbits, the irritation score (equivalent to AOI) was 18.8 (maximum 110), and it was slightly irritating. Symptoms gradually improved from 48 to 120 hours, all scored zero after seven days (SIDS (1996)), and the animals fully recovered. Therefore, it was classified in Category 2B.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	It was not sensitizing in skin sensitization tests with guinea pigs: a maximization test (OECD 406; GLP) and a Buehler test, which gave negative results (SIDS (1996)), but other tests by a maximization test were positive (SIDS (1996)), indicating that this substance is sensitizing or has an allergenic potential. On the other hand, as for humans, no sensitization reactions were shown in a maximization test in 25 subjects, and the negative result in humans supports the opinion that this substance is not a sensitizer (SIDS (1996)). From the above, multiple test data were shown in animals and humans, but because the results were contradicting, and no conclusion was drawn, it was classified as "Classification not possible."	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" based on negative results in micronucleus tests with bone marrow cells after oral or intraperitoneal administration to mice (in vivo somatic cell mutagenicity test) (SIDS (1996), NTP DB (Access on May 2012)). Besides, as for in vitro tests, it was negative in an Ames test (OECD TG471) (NTP DB (1982), SIDS (1996)), and negative in a chromosomal aberration test with CHO cells (OECD TG473) (SIDS (1996)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	It is reported that no carcinogenicity was observed in a 2-year diet administration test with rats (SIDS (1996)), but there are no other important data. Therefore, it was classified as "Classification not possible" due to lack of data.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	It is reported that in a test in which female rats were orally dosed from 7 days before mating throughout mating, gestation, and parturition period until day 4 after parturition, reduced weight gain and decreased food consumption were observed in maternal animals, but no effects were seen in offspring (JECFA 1021 (2002)). However, because the details are unknown, it was classified as "Classification not possible" lack of data.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	In three acute oral toxicity tests with rats, there is a report on congested lung in the first test (2,000-3,980 mg/kg; LD50 = 3,978 mg/kg), hyperemia of the lung and liver and gastrointestinal inflammation in the second test (2,510-3,960 mg/kg; LD50 = 3,300 mg/kg), and hemorrhagic lung, gastrointestinal irritation, congested kidney and adrenal gland in the third test (2,150-10,000 mg/kg; LD50 = 3,830 mg/kg) (SIDS (1996)), but all were findings in the dead animals, seen at doses above the upper limit of the guidance values. And in a test by dermal administration of 2,000 mg/kg to rats, no deaths, clinical signs, or anomalies at necropsy were observed (SIDS (1996)). From the above, it was thought to correspond to "Not classified" in the oral and dermal routes because there were no findings except for death cases in oral administration tests, in which doses were set to be equal to or higher than the upper limit of the guidance value range, and no abnormalities were found after dermal administration at the dose of the upper limit of the guidance value range. However, because there are no data and effects are unknown in the inhalation route, it was classified as "Classification not possible" for specific target organ toxicity (single exposure).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	NOEL in repeated oral administration tests with rats is reported to be 3,000 ppm (150 mg/kg/day) or above in a 91-day diet administration test, 10,000 ppm (500 mg/kg/day) or above in a 16-week diet administration test, 10,000 ppm (500 mg/kg/day) or above in a 26-week diet administration test, 50,000 ppm (2,500 mg/kg/day) or above in a 1-year diet administration test, and 20,000 ppm (1,000 mg/kg/day) or above in a 2-year diet administration test (SIDS (1996)), and it exceeded the upper limit of the guidance value range in multiple tests. Furthermore, in a test in which dogs were given capsules for 26 weeks, no adverse effects including those in histopathological examinations were reported at 100 mg/kg/day corresponding to the upper limit of the guidance value range (SIDS (1996)). From the above results, it corresponds to "Not classified" in the oral route. However, because there are no data or data are lacking in the other routes, it was classified as "Classification not possible" for specific target organ toxicity (repeated exposure). Besides, it is reported that 4-month inhalation exposure in rats affected the nervous system, cardiovascular system, etc. (USEPA/HPV (2001)), but the details on test conditions such as exposure time and test results are unknown.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2012	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)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 96-hour LC50 = 57 mg/L for fish (Pimephales promelas) (SIDS, 2002).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to rapid degradability (a degradation rate by BOD: 97% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1993)), and 21-day NOEC = 5.9 mg/L for crustacea (Daphnia magna) (SIDS, 2002). 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" due to rapid degradability (a degradation rate by BOD: 96.7% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2003)), and a low bioaccumulation estimate (LogKow = 1.21 (PHYSPROP Database (2009))), although it corresponds to "Not classified" in acute toxicity for fish (SIDS, 2002). From the above results, it was classified as "Not classified."	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2012	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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