GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 1222-05-5
Chemical Name 4,6,6,7,8,8-Hexamethyl-1,3,4,6,7,8-hexahydrocyclopenta[g]isochromene
Substance ID H27-A-062/C-140A_P
Classification year (FY) FY2015
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) 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 present in the molecule associated with explosive properties.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- - "Liquids" according to GHS definition.
3 Aerosols Not applicable
-
-
- - Not an aerosol product.
4 Oxidizing gases Not applicable
-
-
- - "Liquids" according to GHS definition.
5 Gases under pressure Not applicable
-
-
- - "Liquids" according to GHS definition.
6 Flammable liquids Not classified
-
-
- - Based on a flash point of > 100 degrees C (closed cup) (EU-RAR (2008)), it was classified as "Not classified."
7 Flammable solids Not applicable
-
-
- - "Liquids" according to GHS definition.
8 Self-reactive substances and mixtures Not applicable
-
-
- - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Classification not possible
-
-
- - Due to no data, the classification is not possible.
10 Pyrophoric solids Not applicable
-
-
- - "Liquids" according to GHS definition.
11 Self-heating substances and mixtures Classification not possible
-
-
- - No established test method suitable for liquid substances.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable
-
-
- - Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable
-
-
- - It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is not chemically bonded to the elements other than carbon or hydrogen.
14 Oxidizing solids Not applicable
-
-
- - "Liquids" according to GHS definition.
15 Organic peroxides Not applicable
-
-
- - It is an organic compound that does not contain bivalent -O-O- structure in the molecule.
16 Corrosive to metals Classification not possible
-
-
- - Due to no data, the classification is not possible.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- - From reported LD50 values of > 3,000 mg/kg and > 3,250 mg/kg for rats (EU-RAR (2008)), it was classified as "Not classified."
1 Acute toxicity (Dermal) Not classified
-
-
- - From a reported LD50 value of > 6,500 mg/kg for rats (EU-RAR (2008)) and a reported LD50 value of > 3,250 mg/kg for rabbits (EU-RAR (2008)), it was classified as "Not classified."
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - "Liquids" according to GHS definition.
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
2 Skin corrosion/irritation Not classified
-
-
- - In 3 skin irritation tests with 4-hour application of a 65% solution of this substance to rabbits (Directive 79/831/EEC, GLP compliance), very slight to apparent erythema and very slight edema were observed, but there is only one animal whose average score of erythema exceeded 2. It is written that erythema and edema found in these tests did not resolve in 7 out of 15 animals even seven days after application, but the results after that were not shown (EU-RAR (2008)). Therefore, judging that a degree of irritation was slight, the substance was classified as "Not classified."
3 Serious eye damage/eye irritation Not classified
-
-
- - It is reported that the substance is practically not irritating from a primary eye irritation index of 3.5, 1.17 and 0 (average 1.6) after 24, 48 and 72 hours based on irritation found in 2 out of 6 animals in an eye irritation test in which 0.1 mL of a 65% solution of the substance was applied to rabbits (OECD TG 405, GLP compliance) (EU-RAR (2008)). Therefore, the substance was classified as "Not classified."
4 Respiratory sensitization Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
4 Skin sensitization Not classified
-
-
- - It is reported that in multiple skin sensitization tests in humans (an HRIPT test, a maximization test, and a patch test), sensitization was not observed (EU-RAR (2008)). Moreover, it is reported that in maximization tests using guinea pigs, the substance is unclear or not sensitizing (EU-RAR (2008)). It is concluded in EU-RAR (2008) that this substance is not a sensitizing substance because there is no clear evidence that it induces sensitization. From the above, the substance was classified as "Not classified."
5 Germ cell mutagenicity Classification not possible
-
-
- - As for in vivo, a micronucleus test in mouse bone marrow cells was negative, and as for in vitro, a bacterial reverse mutation test, a chromosomal aberration test in cultured mammalian cells, a micronucleus test and a sister chromatid exchange test in human lymphocytes were negative (EU-RAR (2008)). From the above, the substance was classified as "Classification not possible" in accordance with Guidance.
6 Carcinogenicity Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
There is no information on human reproductive effects. However, this substance was detected in human body milk in multiple reports. For example, it is reported that in a German study which analyzed body milk samples taken from 107 mothers who had use experiences of commodities containing this substance and were nursing babies, the substance was detected at maximum 1,316 micro g/kg fat (corresponding to 48 micro g per 1 kg of body milk assuming a milk fat content of 3.67%) (EU-RAR (2008), SIDS SIAP (2008)).
As for experimental animals, in a teratogenicity test in pregnant rats in gavage administration of this substance during an organogenetic period, maternal animals showed weight gain reduction and decreased food consumption at 150 mg/kg/day or higher and clinical signs (salivation, urine-stained abdominal region and so on) added at 500 mg/kg/day. In fetuses, an increased incidence of malformations in vertebrae/ribs in addition to lower fetus weight and increased unossification/unossified sternebrae were observed at 500 mg/kg/day. It is written that an incidence of skeletal malformations significantly increased not only per fetus but per brood (EU-RAR (2008), SIDS SIAP (2008), HSDB (Access on October 2015)). On the other hand, there is no report from a multiple-generation reproductive toxicity test of this substance, and toxic effects on fertility and development/growth of next generation in the high-dose administration are unknown. Besides, in a gavage administration test in pregnant rats administered from late gestation by weaning of F1 and in F1 pregnant females obtained by mating after growth administered from perinatal period by weaning of F2 respectively at maximum 20 mg/kg/day, toxic effects were not found in fertility of F0 and F1 parent animals, and development and postnatal growth of F1 and F2 offspring. However, in a kinetics test built in this test in oral administration (of a 14C-labeled compound) at 2 and 20 mg/kg/day in F0 maternal animals, the result suggesting that this substance (including metabolites) was transferred to F1 newborns via milk (corresponding to 2.28 and 32.8 mg this substance /L milk) were obtained (EU-RAR (2008), SIDS SIAP (2008)).
From the above, although only in one report because skeletal malformations were found in fetuses at a dose where maternal toxicity occurred in a teratogenicity test in rats, the substance was classified in Category 2 in this hazard class. Besides, although there are reports of milk transfer in rats and cases detecting this substance in human body milk, toxic effects on next generation via lactation were not reported so far. Therefore, it is thought that a concentration in milk did not reach the toxicity level, and the additional category for effects on or via lactation was not adopted.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - There are no human data.
As for experimental animals, in a 90-day diet administration toxicity test using rats, effects were not found up to 150 mg/kg/day, the maximum dose of this test. Besides this, there are reports from toxicity tests in inhalation and dermal routes for a mixture, but the test conditions are not appropriate to specify target organs.
Therefore, the substance was classified as "Classification not possible."
10 Aspiration hazard Classification not possible
-
-
- - Due to lack of data, the classification is not possible.

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 1


Warning
H400 P273
P391
P501
From 48-hour LC50 = 0.47 mg/L for crustacea (Acartia tonsa) (SIAP, conclusions agreed in SIAM 28, 2009), it was classified in Category 1.
11 Hazardous to the aquatic environment (Long-term) Category 1


Warning
H410 P273
P391
P501
Due to being not rapidly degradabile (BioWin), and 6-day NOEC (develop) = 0.038 mg/L for crustacea (Acartia tonsa) (EU-RAR, 2008), it was classified in Category 1.
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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