GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
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 | H27-A-029/C-059A_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 |
| 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 |
- |
- | - | A flash point is 117 degrees C (closed cup) (GESTIS (Access on July 2015)). |
| 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 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)) |
| 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. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 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). |
| 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." |
| 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 |
- |
- | - | 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). |
| 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. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 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. |
| 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)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 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)). |
| 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). |
| 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). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 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 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. |
| 11 | Hazardous to the aquatic environment (Long-term) | 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. |
| 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. |