GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 21145-77-7,1506-02-1
Chemical Name 6-Acetyl-1,1,2,4,4,7-hexamethyltetralin
Substance ID R01-A-027
Classification year (FY) FY2019
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) 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)  
Model SDS by MHLW (External link)  
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 *
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2 Flammable gases *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3 Aerosols *
-
-
- - Not aerosol products. It was classified as "Not classified (Not applicable)."
4 Oxidizing gases *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5 Gases under pressure *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6 Flammable liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7 Flammable solids *
-
-
- - It was classified as "Not classified" from information that it is not combustible (EU-RAR (2008)).
8 Self-reactive substances and mixtures *
-
-
- - There are no chemical groups associated with explosive or self-reactive properties present in the molecule. It was classified as "Not classified (Not applicable)."
9 Pyrophoric liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10 Pyrophoric solids *
-
-
- - It was classified as "Not classified" from information that it is not combustible (EU-RAR (2008)).
11 Self-heating substances and mixtures *
-
-
- - It was classified as "Not classified" from information that it is not combustible (EU-RAR (2008)).
12 Substances and mixtures which, in contact with water, emit flammable gases *
-
-
- - 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 (Not applicable)."
13 Oxidizing liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14 Oxidizing solids *
-
-
- - 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 (Not applicable)."
15 Organic peroxides *
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16 Corrosive to metals *
-
-
- - It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data.
17 Desensitized explosives *
-
-
- - 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) Category 4


Warning
H302 P301+P312
P264
P270
P330
P501
[Rationale for the Classification]
Based on (1)-(4), it was classified in Category 4.

[Evidence Data]
(1) LD50 for rats: 825-1,377 mg/kg (SIAP (2008))
(2) LD50 for rats: 570 mg/kg (HSDB (Access on September 2019))
(3) LD50 for rats: 920 mg/kg (HSDB (Access on September 2019), REACH registration dossier (Access on October 2019))
(4) LD50 for rats: 1,377 mg/kg (HSDB (Access on September 2019))
1 Acute toxicity (Dermal) *
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) LD50 for rats: 7,940 mg/kg (SIAP (2008), HSDB (Access on September 2019))
(2) LD50 for rabbits: >5 g/kg (5,000 mg/kg) (HSDB (Access on September 2019))
1 Acute toxicity (Inhalation: Gases) *
-
-
- - [Rationale for the Classification]
Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1 Acute toxicity (Inhalation: Vapours) *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
2 Skin corrosion/irritation *
-
-
- - [Rationale for the Classification]
Based on (1)-(3), it was classified as "Not classified."

[Evidence Data]
(1) No skin reaction was observed in a skin irritation test in which this substance (0.5 mL) was applied semi-occlusively to rabbits for 4 hours (EU-RAR (2008)).
(2) In a skin test in which this substance (0.5 mL) was applied semi-occlusively to rabbits for 4 hours in compliance with EU Method B.4 (Acute Toxicity: Dermal Irritation/Corrosion), the mean scores for erythema and edema at 24/48/72 hours were all 0 (REACH registration dossier (Access on November 2019)).
(3) This substance is not corrosive or irritating to the skin of animals and humans (SIAP (2008), HSDB (Access on September 2019)).
3 Serious eye damage/eye irritation Category 2


Warning
H319 P305+P351+P338
P337+P313
P264
P280
[Rationale for the Classification]
Based on (1)-(3), it was classified in Category 2. Besides, there is one finding in which the recovery period exceeded 21 days, but the symptoms were slight. Therefore, it was not classified in Category 1.

[Evidence Data]
(1) In an eye irritation test with rabbits according to OECD TG 405, the mean scores for cornea opacity, the iris, conjunctival redness and conjunctival chemosis at 24/48/72 hours were 0.22, 0.00, 1.22, 1.00, respectively, and complete recovery occurred by 7 days (EU-RAR (2008)).
(2) In an eye irritation test with rabbits according to OECD TG 405, the mean scores for cornea opacity, the iris, conjunctival redness and conjunctival chemosis at 24/48/72 hour were 0.67, 0.22, 1.44, 1.22, respectively, and all these cleared by 29 days (EU-RAR (2008), REACH registration dossier (Access on November 2019)).
(3) This substance is very slightly irritating to the eyes (SIAP (2008), HSDB (Access on September 2019)).
4 Respiratory sensitization *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization *
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) No sensitization was observed in a skin sensitization test (open epicutaneous test) with guinea pigs (EU-RAR (2008), REACH registration dossier (Access on November 2019)).
(2) This substance was not sensitizing in sensitization tests with humans and experimental animals (SIAP (2008), HSDB (Access on September 2019)).
5 Germ cell mutagenicity *
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) As for in vivo, a negative result was reported in a micronucleus test with mice (EU-RAR (2008), Environmental Risk Assessment for Chemical Substances Vol.17 (Ministry of the Environment, 2019)).
(2) As for in vitro, negative results were reported in bacterial reverse mutation tests, and micronucleus tests, sister chromatid exchange tests and an unscheduled DNA synthesis test with cultured mammalian cells (EU-RAR (2008), Environmental Risk Assessment for Chemical Substances Vol.17 (Ministry of the Environment, 2019)).
6 Carcinogenicity *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
7 Reproductive toxicity *
-
-
- - [Rationale for the Classification]
Data in (1) and (2) were obtained. However, as for (1), the dose setting was such that no effects were observed in maternal animals even at the highest dose of the test. Therefore, it was classified as "Classification not possible" due to lack of data.

[Evidence Data]
(1) In a perinatal and postnatal study with rats dosed by gavage, no toxicity in maternal animals and pups or reproductive effects were observed at up to the highest dose of 20 mg/kg/day (SIAP (2008), HSDB (Access on September 2019)).
(2) In a developmental toxicity test with female rats dosed by gavage on gestational days 7-17, no developmental effects were observed even at the dose where maternal toxicity (reduced body weight gain, localized alopecia and color changes in the liver (green or mottled green and dark red)) was observed (Environmental Risk Assessment for Chemical Substances Vol.17 (Ministry of the Environment, 2019), EU-RAR (2008)).
8 Specific target organ toxicity - Single exposure *
-
-
- - [Rationale for the Classification]
There are no reports on single exposure to this substance in humans. In the result of (1) in experimental animals, hematuria was observed. However, since it is difficult to specify the target organ based on this finding alone, it was not adopted as the evidence. In addition, the finding of lethargy observed in (2) was also not adopted because it was the finding observed in the vicinity of the lethal dose. Therefore, it was classified as "Classification not possible."

[Reference Data, etc.]
(1) In a single oral dose test with rats, sluggishness and piloerection were observed a few hours after a gavage administration at 700-1,451 mg/kg (corresponding to Category 2), followed by hematuria within 2 days, and encrustations around the eyes and nostrils and signs of emaciation were observed a few days later. On autopsy of the animals that died within a few days after administration, blood-stained urine in the bladder was observed. Symptoms continued for about 1 week after administration, but the surviving animals (described to be 9 out of 10 animals in the 700 mg/kg group and 6 out of 10 animals in the 840 mg/kg group) recovered gradually looking healthy 14 days (end of observation) after administration (EU-RAR (2008), REACH registration dossier (Access on November 2019)).
(2) In a test in which rats were given a single oral dose of this substance at 1,260-2,520 mg/kg, signs of lethargy, piloerection and emaciation were observed as general symptoms. The minimum dose where effects were observed was not described. However, based on the LD50 value of 1,377 mg/kg (males and females), the effects were considered to be within the range of Category 2 around the LD50 value (EU-RAR (2008), SIAP (2008)).
9 Specific target organ toxicity - Repeated exposure Category 2 (liver, blood system)


Warning
H373 P260
P314
P501
[Rationale for the Classification]
Based on (1) and (2), since effects on the liver and blood system were observed within the range of Category 2 in oral administration to rats, it was classified in Category 2 (liver, blood system).

[Evidence Data]
(1) As a result of a 2-week repeated dose test with rats by feeding, increased liver weight, etc. were observed at or above 32 mg/kg/day (converted guidance value: 4.98 mg/kg/day, within the range of Category 1), and increased frequency of hepatocellular vacuolation was seen at or above 89 mg/kg/day (converted guidance value: 13.84 mg/kg/day, within the range of Category 2). Hepatocyte necrosis was also observed in 1 animal in the 130 mg/kg/day group whose treatment was discontinued after 5 days (Environmental Risk Assessment for Chemical Substances Vol.17 (Ministry of the Environment, 2019)).
(2) As a result of a 90-day repeated dose toxicity test with rats by feeding, decreased red blood cell counts in females was observed at or above15 mg/kg/day (within the range of Category 2). At 50 mg/kg/day (within the range of Category 2), decreased hemoglobin concentration in males and females, and decreased hematocrit value and erythrocyte counts and light to dark brown discoloration of the urine, etc. in males were observed (EU-RAR (2008), Environmental Risk Assessment for Chemical Substances Vol.17 (Ministry of the Environment, 2019)).

[Reference Data, etc.]
(3) In screening tests conducted to investigate neurotoxicity, as a result of dermal application at 1-100 mg/kg/day for 13 weeks or at 9-36 mg/kg/day for 26 weeks, no neurotoxicity was observed. At 100 mg/kg/day in the 13-week test and 36 mg/kg/day in the 26-week test, decreases in hemoglobin and red blood cell counts, liver discoloration and prominent liver lobular patterns, hepatocytomegaly, etc. were observed. However, regarding these effects, it was described in EU-RAR (2008) that the NOAEL could not be determined because the actual dose was unclear (EU-RAR (2008)).
10 Aspiration hazard *
-
-
- - [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 1


Warning
H400 P273
P391
P501
It was classified in Category 1 from 48-hour EC50 = 0.61 mg/L for crustacea (Nitocra spinipes) (SIAP, 2009).
11 Hazardous to the aquatic environment Long term (Chronic) Category 1


Warning
H410 P273
P391
P501
It was classified in Category 1 due to being not rapidly degradable (BIOWIN), and 34-day NOEC = 0.035 mg/L for fish (Danio rerio) (EU-RAR, 2008, SIAP, 2008, Environmental Risk Assessment for Chemical Substances Vol. 17 (Ministry of the Environment, 2019)).
12 Hazardous to the ozone layer Classification not possible
-
-
- - Classification not possible due to lack of data.


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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