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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	78-70-6
Chemical Name	Linalool
Substance ID	24A6020
Classification year (FY)	FY2012
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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 (it contains an unsaturated C-C bond but not 1,2-dienes).
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	Category 4	- Warning	H227	P370+P378 P403+P235 P210 P280 P501	It corresponds to Category 4 from a flash point of 71 deg C [closed-cup] (HSDB (2009)) > 60 deg C and <= 93 deg C.
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with self-reactive properties (unsaturated bond) in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 235 deg C (HSDB (2009)).
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.
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)	Not classified	- -	-	-	It was classified as "Not classified" in the Classification JIS (corresponding to Category 5 in UN GHS classification) based on an LD50 value of 2,790 mg/kg for rats (SIDS (2004)). Besides, as for health hazards, also refer to the health hazards of citronellal (CAS: 106-23-0) and 3,7-dimethyl-2,6-octadienal (synonym citral) (CAS: 5392-40-5), which are the related substances.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	There are three LD50 values for rabbits: 2,000 mg/kg, > 5,000 mg/kg (both SIDS (2004)), and 5,610 mg/kg (USEPA/HPV (2001), corresponding to List 1), one corresponds to Category 4, and two correspond to "Not classified." It was classified as "Not classified" to which most corresponded.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	A test by a 4-hour semi-occlusive application of 0.5 mL of the undiluted test substance to the skin of rabbits (3 or 4 animals) (OECD TG404, GLP) was conducted three times, and the primary skin irritation index (PII) was 3.33, 3.42, and 2.08, respectively (ECETOC TR66 (1995)). As for the degree of irritation, because PII corresponded to moderate (corresponding to PII 3-5) in two tests out of three tests, it was classified in Category 2. PII in the remaining one test was less than 3, corresponding to slight.
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In a test in which 0.1 mL of the undiluted test substance was applied to the conjunctival sac of three rabbits (OECD TG405), all three animals showed well-defined edema and erythema in the conjunctiva and clearly increased discharge after 1 hour, and slight corneal opacity and well-defined to severe conjunctival redness after 1 day, but no symptoms were observed except for corneal opacity in one animal 8 days after the application, and irritation symptoms disappeared in all the animals on day 15 (SIDS (2004)). Because the sign of corneal opacity remained in one animal 8 days after the application and did not disappear within 7 days, it was classified in Category 2A. Besides, concerning the results of the test, it is described in the assessment document (SIDS (2004)) that there were clear signs of ocular reactions, but these were transient and resolved within some days, and the substance had a low potential of eye irritation, and it was assessed to be not irritating. And irritation was reported to be moderate in another test in which 0.1 mL was applied to rabbits (SIDS (2004)).
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	It was classified in Category 1 because it is listed as a sensitizer in Contact Dermatitis (Frosch) (5th, 2011) (corresponding to List 1). Besides, it was reported to be not sensitizing in a skin sensitization test with guinea pigs (Draize test) (SIDS (2004)). And as for humans, it is reported that 119 patients with cosmetic-related contact dermatitis were challenged in a patch test, and one showed an allergic response to this substance (SIDS (2004)), and it is reported that 76 patients out of 1781 patch-tested were determined were determined to have cosmetic allergy, and in three of them, this substance was identified to be a causative allergen (SIDS (2004)).
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" based on a negative result in a micronucleus test with bone marrow cells after oral administration to mice (in vivo somatic cell mutagenicity test) [OECD TG474, GLP] (SIDS (2004)). Besides, as for in vitro tests, it is reported that it was negative in an Ames test (NTB DB (Access on May 2002)), negative in a chromosomal aberration test with fibroblast of Chinese hamsters (SIDS (2004)), and weakly positive in a gene mutation test with mouse lymphoma cells (USEPA/HPV (2001)).
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a reproductive test in which female rats were orally dosed from 7 days before mating with untreated males and were continuously dosed throughout mating and gestation period until day 3 after parturition (FDA guidelines (1966), GLP), fetal deaths, a concomitant decrease in live litter size, and a significant increase in pup mortality during the first four or five days postpartum were reported as effects in offspring in the high-dose group (1,000 mg/kg/day) in which maternal animals showed general toxicity of salivation, reduced weight gain, and decreased food consumption (SIDS (2004)). Therefore, it was classified in Category 2. Besides, it is reported that in a developmental toxicity test in which rats were orally dosed on gestational days 7-17, maternal animals in the high-dose group (1000 mg/kg/day) showed reduced weight gain, but Caesarean section and necropsy on gestational day 21 revealed no effects on developmental parameters such as the number of corpora lutea, the number of implantations, the number of live fetuses, and early and late resorptions, and findings in inspections of external, soft tissue, and skeletal system of fetuses (JECFA 1156 (2011)).
8	Specific target organ toxicity - Single exposure	Category 3 (Narcotic effects)	Warning	H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	It was classified in Category 3 (narcotic effects) because ataxia after oral administration to rats (SIDS (2004)), somnolence, ataxia, and dyspnea after oral administration to mice (SIDS (2004)), and depression after dermal administration to rabbits (US EPA/HPV (2001)) were observed as toxic signs after administration of this substance. Besides, oral LD50 values for rats and mice and a dermal LD50 value for rabbits were all above 2,000 mg/kg for this substance (SIDS (2004), US EPA/HPV (2001)), and its toxicity was low.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a 28-day repeated oral administration test with rats, changes in a part of clinical test values, increased weights of the liver and kidney, thickened liver lobes, pale areas on the kidney, hepatocellular cytoplasmic vacuolization, and thickening, erosion, and inflammation of the stomach mucosa with concomitant lesions in the non-glandular part were observed at or above 400 mg/kg/day (converted guidance value: 91 mg/kg/day), and an increase in degenerative lesions in the renal cortex was found in males at 1,000 mg/kg/day (converted guidance value: 227 mg/kg/day) (SIDS (2004)). On the other hand, in a test with rats given 64-day oral administration of 500 mg/kg/day (converted guidance value: 356 mg/kg/day) to investigate drug-metabolizing enzymes in the liver, significant effects were limited to biphasic changes in liver enzymes and a slight increase in liver weights, which were interpreted as adaptive changes rather than toxicity (SIDS (2004)). In the 28-day administration test above, findings in the liver and kidney in the 400 mg/kg/day group were slight, and degenerative lesions in the renal cortex seen in the 1000 mg/kg/day group were findings at the high dose above the upper limit of the guidance value range. On the other hand, findings in the stomach were not used for the rationale of the classification because these were regarded as local effects of oral administration due to irritation by this substance. From the above, it was classified as "Classification not possible" due to lack of data.
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

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	It was classified in Category 3 from 96-hour LC50 = 27.8 mg/L for fish (Oncorhynchus mykiss) (SIDS, 2005).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to rapid degradability (readily biodegradable, a degradation rate by BOD: 90% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1996)), and 72-hour NOEC = 5.6 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1998)). 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 (readily biodegradable, a degradation rate by BOD: 90% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1996)), and a low bioaccumulation estimate (LogKow = 2.97 (PHYSPROP Database (2009))), although it corresponds to Category 3 in acute toxicity for fish (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1998)). From the above results, it was classified as "Not classified."
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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.

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