GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 78-69-3
Chemical Name 3,7-Dimethyloctan-3-ol; Tetrahydrolinalool
Substance ID R02-B-113-MHLW, MOE
Classification year (FY) FY2020
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 FY2010  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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 classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2 Flammable gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products. It was classified as "Not classified."
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
5 Gases under pressure Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
6 Flammable liquids Category 4
-
Warning
H227 P370+P378
P210
P280
P403
P501
It was classified in Category 4 based on a flash point of 77 deg C (closed cup) (REACH registration dossier (Access on October 2020)).
7 Flammable solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
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. It was classified as "Not classified."
9 Pyrophoric liquids Not classified
-
-
- - It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 365 deg C (REACH registration dossier (Access on October 2020)).
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
11 Self-heating substances and mixtures Classification not possible
-
-
- - Classification is not possible because test methods applicable to liquid substances are not available.
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). It was classified as "Not classified."
13 Oxidizing liquids 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. It was classified as "Not classified."
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
16 Corrosive to metals Classification not possible
-
-
- - No data available.
17 Desensitized explosives Not classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) LD50 for rats: > 5,000 mg/kg (REACH registration dossier (Access on October 2020), BUA 253 (2004))
(2) LD50 for rats: 8,270 mg/kg (REACH registration dossier (Access on October 2020), BUA 253 (2004))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) LD50 for rabbits: > 5,000 mg/kg (REACH registration dossier (Access on October 2020), BUA 253 (2004))
1 Acute toxicity (Inhalation: Gases) Not classified
-
-
- - [Rationale for the Classification]
Liquid (GHS definition). It was classified as "Not classified."
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - [Rationale for the Classification]
There was information of (1), but because the category cannot be determined, it was classified as "Classification not possible."

[Reference Data, etc.]
(1) In a test by inhalation exposure to the vapor of this substance in rats, there was no dead animal (0/12) after 8-hour exposure to 0.885 mg/L (converted 4-hour equivalent value: 193 ppm) (REACH registration dossier (Access on October 2020)).
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
[Rationale for the Classification]
It was classified in Category 2 because Category 1 or 2 was estimated from (1), and the possibility of corrosion (Category 1) was considered to be low from (2). Besides, although the name of the skin model was not described in data of (1), it was judged that EpiDerm was used from test conditions, etc., and it was confirmed that it met the acceptance criteria for the current OECD TG 439, judging from test results.

[Evidence Data]
(1) In an in-vitro skin irritation test using reconstructed human epidermis model according to Draft OECD guideline, it was judged as irritating (REACH registration dossier (Access on November 2020)).
(2) In a skin irritation test with rabbits (BASF test), after 1-minute, 5-minute, or 15-minute application to the dorsal skin, slight erythema was observed and disappeared after 6 days, and after 20-hour application to the auricle, well-defined to moderate erythema and edema were found and disappeared after 8 days (REACH registration dossier (Access on November 2020)).
3 Serious eye damage/eye irritation Category 2A


Warning
H319 P305+P351+P338
P337+P313
P264
P280
[Rationale for the Classification]
It was classified in Category 2A from (1).

[Reference Data, etc.]
(1) In an eye irritation test with rabbits (BASF test, application amount: 50 microL), no effects on the iris were seen, but irritation reactions were observed in the cornea and conjunctiva and did not disappear by 8 days after application (REACH registration dossier (Access on November 2020)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Category 1B


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
[Rationale for the Classification]
It was classified in Category 1B from (1). The classification result was changed due to new data obtained.

[Evidence Data]
(1) In a mouse local lymph node assay (LLNA) according to TG 429, it was judged as positive, and EC3 was reported to be 7.6% (REACH registration dossier (Access on November 2020)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) As for in vitro, it was reported to be negative in a bacterial reverse mutation test, a gene mutation test and a chromosomal aberration test using cultured mammalian cells (REACH registration dossier (Access on October 2020)).
6 Carcinogenicity Classification not possible
-
-
- - [Rationale for the Classification]
No data available.
7 Reproductive toxicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification was not possible due to lack of data.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - [Rationale for the Classification]
Classification was not possible due to lack of data.

[Reference Data, etc.]
(1) In an acute oral toxicity test with rats (There was no description of the minimum dose at which effects were observed. It was assumed that effects were observed at a dose near the LD50 (8,270 mg/kg) which was lower than the doses exceeding the range for Category 2), dyspnea, apathy, lateral position, staggering, atonia, sedative-like state with loss of corneal and pain reflex, ataxia, spastic movements, diarrhea, salivation, and lacrimation were observed, and in the animals that died, acute dilatation of the heart and acute venous stasis were observed (REACH registration dossier (Access on October 2020)). Since these findings were obtained at an extremely high dose (8,270 mg/kg), they were adopted as reference data.
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - [Rationale for the Classification]
Classification was not possible due to lack of data.

[Reference Data, etc.]
(1) It was reported that in a three-month feeding test with rats, at 15,000 ppm (converted guidance value: 750 mg/kg/day, exceeding Category 2), reduced body weight gain and shortened prothrombin time were observed, and furthermore, decreases in blood glucose and chlorine level and an increase in potassium level were observed in males (REACH registration dossier (Access on November 2020)).
10 Aspiration hazard Classification not possible
-
-
- - [Rationale for the Classification]
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 Short term (Acute) Category 2
-
-
H401 P273
P501
It was classified in Category 2 from 96-hour LC50 = 8.9 mg/L for fish (Danio rerio) (REACH registration dossier, 2021). The classification result was changed from the previous classification by using new information.
11 Hazardous to the aquatic environment Long term (Chronic) Not classified
-
-
- - Reliable chronic toxicity data were not obtained. It was classified as "Not classified" because it was rapidly degradable (a 28-day degradation rate by BOD: 73% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 2012)) and due to a low bioaccumulation estimate (log Kow = 3.3 (REACH registration dossier, 2021)). The classification result was revised from the previous classification by changing how to classify it for chronic toxicity.
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.
  • 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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