NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	15571-58-1
Chemical Name	2-Ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate [DOTE]
Substance ID	m-nite-15571-58-1_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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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 present in the molecule associated with explosive properties.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified	- -	-	-	A flash point is 117 degrees C (closed cup) (GESTIS (Access on July 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Classification not possible	- -	-	-	Due to no data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No established test method suitable for liquid substances.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It is estimated that it does not react vigorously with water from water solubility data measured. Water solubility: < 0.1 mg/L (SIDS (2009))	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	It is an organic compound that does not contain bivalent -O-O- structure in the molecule.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Due to no data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	- -	-	-	From an LD50 value of 2,000 mg/kg, 2,775 mg/kg, and 3,050 mg/kg for rats (SIDS (2009)), it was classified as "Not classified" (Category 5 in UN GHS classification).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	From an LD50 value of > 2,000 mg/kg for rats (SIDS (2009)), it was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	It is reported that in a skin irritation test using rabbits (OECD TG404, GLP compliance), as a result of an applicaton of a solution containing 90% this substance (10% Octyltin tris (2-EHMA) CAS number: 27107-89-7), slight scaling was observed but resolved within ten days (SIDS (2009)). From the above result, it was classified as "Not classified" (Category 3 in UN GHS classification).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	It is reported that in an eye irritation test using rabbits, after an appliccation of 0.1 mL undiluted this substance (> 98%) to conjunctival sac for 96 hours, irritation was observed in the conjunctiva, but it resolved within four days (SIDS (2009)). From the above, it was classified in Category 2.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	It is reported that in a sensitization test (OECD TG 406, GLP compliance) in which a solution containing 90% this substance (10% Octyltin tris (2-EHMA) CAS number: 27107-89-7) was applied to guinea pigs, a positive reaction was observed (SIDS (2009)). Besides, it is reported that in a sensitization test (OECD TG 406, GLP compliance) using a solution containing this substance (this substance 70%, Octyltin tris (2-EHMA) 30%), a clear positive reaction was found (SIDS (2009)). The substance was classified in Category 1 from the above results.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification is not possible due to lack of data. There are no in vivo data, and as for in vitro, negative and positive data were reported in a bacterial reverse mutation test (SIDS (2009)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	There are no data on this substance itself. However, WHO (CICAD 73 (2006)) and OECD (SIDS (2009)) evaluated hazards of this substance as a dioctyltin compound from the test data on analog substances. Namely, in SIDS, three substances of this substance, dioctyltin dichloride (DOTC: CAS number 3542-36-7), and dioctyltin bis (isooctyl thioglycolate) (DOT (IOTG); CAS number 26401-97-8) were handled as substances in the same category. For two substances other than this substance, there are test results on reproductive/developmental toxicity in experimental animals, and strong reproductive/developmental toxicity including teratogenicity was reported (SIDS (2009), CICAD 73 (2006)). It is written that in a two-generation reproductive toxicity test in which a mixture containing DOT (IOTG) and a monooctyl form, MOT (IOTG) in a ratio of 78.8: 16.9 was administered to rats in the diet, decreased thymus weight in parent animals of F0 and F1 generations, and increased stillbirths in F1 generation were observed, and NOAEL was 20 ppm (0.5 to 0.7 mg/kg/day) (SIDS (2009)). It is written that in a screening reproductive toxicity test (OECD TG 421) in which DOTC (94.1%) was administered to rats in the diet, a marked decrease in thymic lymphocytes at a low dose (10 ppm: 0.5 to 0.7 mg/kg/day) or higher and reductions in weight gain and thymus weight, a decreased litter size, increased stillbirths at a middle dose of 100 ppm (4.2 to 5.9 mg/kg/day) or above were found in parent animals. In offspring, there is information that increased dwarf pups and an increase in neonatal deaths by day four after birth were shown (SIDS (2009)). Therefore, reproductive/developmental effects were observed with general toxic effects from an extremely low dose. On the other hand, as developmental toxicity, in a teratogenicity test in which a 80 : 20 mixture of DOT (IOTG) and MOT (IOTG) was administered by gavage to mice, rats or rabbits, only increased deaths of fetuses were observed at the dose (25 mg/kg/day) where reduced weight gain was found in maternal animals in rats. However, in mice, cleft palate was observed at or above a dose (67 mg/kg/day) slightly above the dose (45 mg/kg/day) where a decrease in thymus weight was found in maternal animals. Furthermore, at 100 mg/kg/day, an increased incidence of malformations such as bent forelimbs or hindlimbs, curvature or union of rib, spinal curve, and exencephaly were observed (SIDS (2009), CICAD 73 (2006)). In rabbits, general toxicity effects were not found in maternal animals even dosed up to 100 mg/kg/day, but in fetuses, incomplete ossification of cranial bones at 10 mg/kg/day and malformation in viscera (pyelectasia, malformation in small vessel with its source derived from arterial arch, skeletal abnormality) at 100 mg/kg/day were found. A NOAEL value for minimal developmental toxicity was reported to be 1 mg/kg/day from the effects on fetuses (SIDS (2009), CICAD 73 (2006)). As above, strong reproductive/developmental effects including teratogenicity were found in experimental animals for dioctyltin compounds, analog compounds of this substance. Considering that the similar hazard also for this substance should be taken into account, this substance was classified in "Category 1B" in this hazard class. Besides, EU classified this substance (DOTE) and reaction mass of this substance and MOTE in SVHC as Repr.1B (ECHA (Access on July 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 3 (Narcotic effects)	Warning	H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	There are no human data on this substance. As for experimental animals, piloerection, dyspnea, hunched posture, hypoactivity, incoordination and so on were reported after oral administration in rats. Therefore, it was judged to be narcotic effects (SIDS (2009)). From the above, the substance was classified in Category 3 (narcotic effects).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (immune system), Category 2 (liver, kidney)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	There is no information on this substance. As information on a mixture containing this substance, in a 13-week diet administration toxicity test using rats and this substance (CAS number: 15571-58-1): Octyltin tris (2-EHMA) (CAS number: 27107-89-7): Trioctyltin (2-EHMA) (CAS number: 61912-55-8) (a 97.0: 0.3: 2.17% mixture), the followings was reported (SIDS (2009)): increased relative weights of liver and kidney, decreased weight and atrophy of the thymus, decreased lymphocytes in the thymus, abnormalities in hematological and urine findings at 100 ppm (males: 4 to 5 mg/kg/day, females: 6 mg/kg/day) within a range of Category 1 or higher; and histopathological changes in liver and kidney (no details described) at 250 ppm (males: 11 to 12 mg/kg/day, females: 15 mg/kg/day) within a range of Category 2 or higher. Besides, in a 13-week diet administration toxicity test using rats and this substance (CAS number: 15571-58-1): Octyltin tris (2-EHMA) (CAS number: 27107-89-7) (70: 30 mixture), decreased relative and absolute thymus weight was reported at 50 ppm (3.3 mg/kg/day) within a range of Category 1 or higher (SIDS (2009)). Because 97% this substance was contained in the first test, it was conceivable that it can be used for the classification. Because organotins, especially dibutyltins, dioctyltins, and tributyltins cause a reduction in thymus weight and cellularity in rodents, and a number of possible mechanisms involved in organotin-induced thymus atrophy and subsequent suppression of the T-cell-dependent immune responses have been suggested (CICAD 73 (2006)), effects on thymus were regarded as those on the immune system. Therefore, the substance was classified in Category 1 (immune system), Category 2 (liver, kidney).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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 1	Warning	H400	P273 P391 P501	From 72-hour EC50 = 0.17 mg/L for algae (Desmodesmus subspicatus) and 48-hour EC50 = 0.17 mg/L for crustacea (Daphnia magna) (both SIDS, 2009), it was classified in Category 1.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 1 due to being not rapidly degradabe (BioWin), and 72-hour NOEC(r) = 0.04 mg/L for algae (Desmodesmus subspicatus) (SIDS, 2009). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 4 due to 96-hour LC50 > 24.8 mg/L for fish (Danio rerio) (SIDS, 2009), being not rapidly degradabe, and bioaccumulation estimated (log Kow = 15.35 (>4.0, an estimate, PHYSPROP Database, 2009)) although effects were not observed up to water solubility (an estimate: 1.22x10^-12 mg/L (PHYSPROP Database, 2009)). It was classified in Category 1 by drawing a comparison between the above results.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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.

To GHS Information