GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 168316-95-8
Chemical Name Spinosad; Mixture of Spinosyn A and Spinosyn D
Substance ID R02-A-016-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 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 (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)
-
-
- - Solid (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)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
5 Gases under pressure Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
6 Flammable liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
7 Flammable solids Classification not possible
-
-
- - No data available. Besides, there is information that it is combustible (ICSC (2004)).
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 (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
10 Pyrophoric solids Not classified
-
-
- - It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from information that it decomposes at around 150 deg C (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).
11 Self-heating substances and mixtures Classification not possible
-
-
- - Classification is not possible because test methods applicable to solid (melting point <= 140 deg C) 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)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
14 Oxidizing solids 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."
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
-
-
- - Classification is not possible because test methods applicable to solid substances are not 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) - (5).

[Evidence Data]
(1) LD50 for rats: > 2,000 mg/kg (JMPR (2001))
(2) LD50 for rats: males: > 2,000 - < 5,000 mg/kg, females: > 5,000 mg/kg (JMPR (2001))
(3) LD50 for rats: 3,700 mg/kg (JMPR (2001))
(4) LD50 for rats: females: 5,270 mg/kg, males: > 7,500 mg/kg (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018))
(5) LD50 for rats: females: 5,300 mg/kg, males: > 7,500 mg/kg (JMPR (2001))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) LD50 for rabbits: > 2,000 mg/kg (JMPR (2001), Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016))
(2) LD50 for rabbits: > 5,000 mg/kg (JMPR (2001))
1 Acute toxicity (Inhalation: Gases) Not classified
-
-
- - [Rationale for the Classification]
Solid (GHS definition). It was classified as "Not classified."
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) LC50 for rats (nose exposure, 4 hours): > 5.18 mg/L (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018), EU EFSA (2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016))
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1) - (5).

[Evidence Data]
(1) No irritation was observed in a skin irritation test with rabbits (EU EFSA (2018), Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018), Agricultural Chemicals Times supplement, Agricultural chemicals technology information No. 28 (Japan Crop Protection Association, 1999), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).
(2) No irritation was seen in a skin irritation test with rabbits according to modified OECD TG 404 on this substance (purity 88%) (application amount 5,000 mg/kg, 24-hour semi-occlusive application) (JMPR (2001)).
(3) No irritation was found in a skin irritation test with rabbits according to OECD TG 404 on this substance (purity 87.9%) (JMPR (2001)).
(4) No irritation was observed in a skin irritation test with rabbits according to OECD TG 404 on this substance (purity 88%) (JMPR (2001)).
(5) No irritation was seen in a skin irritation test with rabbits according to OECD TG 404 on this substance (a mixture of spinosad A and D) (JMPR (2001)).
3 Serious eye damage/eye irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1) - (4).

[Evidence Data]
(1) No eye irritation from this substance was seen (EU EFSA (2018)).
(2) In an eye irritation test with rabbits, slight conjunctival redness and edema were observed but disappeared at 48 hours after instillation (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).
(3) It is reported that in an eye irritation test with rabbits according to OECD TG 405 on this substance (purity 87.9%), slight conjunctival redness (mean score 1.7), slight chemosis (mean score 1.3), and slight discharge (mean score 1) were found and persisted by 48 hours in part of the animals, and this substance was a slight eye irritant (JMPR (2001)).
(4) It is reported that in an eye irritation test with rabbits according to OECD TG 405 on this substance (a mixture of spinosad A and D), slight conjunctival redness (mean score 1), slight chemosis (mean score 1), and slight discharge (mean score 1.3) were observed and persisted by 48 hours in part of the animals, and this substance was a slight eye irritant (JMPR (2001)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1) - (3).

[Evidence Data]
(1) No sensitization from this substance was seen (EU EFSA (2018)).
(2) No sensitization was observed in a skin sensitization test with guinea pigs (maximization test, intradermal administration 0.5%) (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018), JMPR (2001), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).
(3) No sensitization was found in a skin sensitization test with guinea pigs (Buehler test) on this substance (purity 87.9%) according to OECD TG 406 (JMPR (2001)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) As for in vivo, in a micronucleus test with the bone marrow cells of orally dosed mice, negative results were reported (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018), JMPR (2001)).
(2) As for in vitro, in a bacterial reverse mutation test, a chromosome aberration test, and a gene mutation test with cultured mammalian cells, negative results were reported (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018), JMPR (2001)).
6 Carcinogenicity Not classified
-
-
- - [Rationale for the Classification]
There are no classification results by domestic and international organizations. There was no report available on humans. Based on (1), it was classified as "Not classified."

[Evidence Data]
(1) In combined chronic toxicity/carcinogenicity studies in which this substance was administered by feeding to male and female rats for two years and male and female mice for 18 months, no treatment-related increase in the incidence of neoplastic lesions was observed, and no carcinogenicity was observed (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018)).
7 Reproductive toxicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (3), it was classified as "Not classified."

[Evidence Data]
(1) In a two-generation reproduction test with rats dosed by feeding, subnormal temperature, reductions in the number of live-born pups and pups per dam, etc. which were considered to be the secondary effects of the worsened physical status (soiled fur in the perineal area, hemorrhage in the vagina, dystocia, etc.) of the maternal animals were observed at a dose of toxicity in parent animals (death (1-3/30 animals), thyroid follicular cell vacuolation, etc. in males and females, worsened physical status in females (soiled fur in the perineal area, hemorrhage in the vagina, dystocia, etc.)) (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018)).
(2) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, no effect was observed in fetuses even at a dose at which maternal toxicity effects (reduced body weight gain) were observed (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018)).
(3) In a developmental toxicity study with female rabbits dosed by gavage on days 7 to 19 of gestation, no effect was observed in fetuses even at a dose at which maternal toxicity effects (reduced body weight gain) were observed (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018)).
8 Specific target organ toxicity - Single exposure Not classified
-
-
- - [Rationale for the Classification]
There was no report on acute exposure effects of this substance in humans. In experimental animals, based on (1) to (3), there were no findings by which target organs could be identified in any of the tests in the oral, dermal, and/or inhalation routes. Therefore, it was classified as "Not classified."

[Evidence Data]
(1) In an acute oral toxicity test with rats, perineal soiling in females at or above 2,000 mg/kg (upper limit of Category 2) and in males at or above 5,000 mg/kg (exceeding Category 2), lacrimation, hypoactivity, and chromorhinorrhea in females at or above 5,000 mg/kg (exceeding Category 2), noisy respiration, salivation, lacrimation, hypoactivity, and accelerated respiration in males at 7,500 mg/kg (exceeding Category 2), and salivation, and lying on side in females at 7,500 mg/kg (exceeding Category 2) were observed (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018)).
(2) In an acute dermal application test with rabbits, at or above 2,000 mg/kg (upper limit of Category 2), there was no death, and no symptoms of clear toxic effects were observed (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018)).
(3) In a 4-hour inhalation exposure test (exposure of the nose) with rats, at 5.18 mg/L (exceeding Category 2), abdominal soiling, hematoid adhering substance around the nose, and bloody tears were observed (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).

[Reference Data, etc.]
(4) In an acute neurotoxicity test with rats dosed by gavage (0, 200, 630, 2,000 mg/kg), at 2,000 mg/kg (upper limit of Category 2), axonal swelling of the temporal lobe of the cerebrum, gracile nucleus (medulla oblongata), spinal cord, posterior lobe of the pituitary gland, etc., nerve fiber degeneration of the pyramid (medulla oblongata), dorsal root ganglion of the spinal cord, and trigeminal ganglion, atrophy of the unilateral retina, and optic nerve, and mineralization to the blood vessels adjacent to the cornea, or eye were observed, but those symptoms were also observed in the control group at the same frequency, and were not considered to be effects of the administration of this substance (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018)).
9 Specific target organ toxicity - Repeated exposure Category 1 (systemic)


Danger
H372 P260
P264
P270
P314
P501
[Rationale for the Classification]
There was no report on hazard by repeated exposure to this substance in humans. In test animals, based on (1), systemic effects considered to be caused by phospholipidosis were observed at or above a dose of Category 1, and it was classified in Category 1 (systemic toxicity).

[Evidence Data]
(1) It was reported that in multiple 4-week to 2-year tests with rats, mice, and dogs dosed by feeding, at or above a dose of Category 1, cytoplasmic vacuolation in the organs and tissues of the brain, lymph node, thyroid, thymus, lung, spleen, liver, gastrointestinal tract, kidney, ovary, etc. was observed (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018), JMPR (2001)). Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018) considered this to be caused mainly by phospholipidosis.
(2) Based on various toxicity test results, effects of the administration of this substance were mainly cytoplasmic vacuolation and aggregation of vacuolated cells in the organs and tissues. This substance was a cationic amphiphilic drug (CAD), and since a lamellar body that was considered to be an accumulation of phospholipids in the lysosome, which was a target organ of CADs, was observed in a histopathological observation with an electron microscope, the cytoplasmic vacuolation in the organs and tissues by the administration of this substance was considered to be caused by phospholipidosis (Risk Assessment Report (Pesticides and Veterinary Medicinal Products) (Food Safety Commission of Japan, 2018), EU EFSA (2018)).
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 = 3.49 mg/L for fish (Cyprinus carpio) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2019)).
11 Hazardous to the aquatic environment Long term (Chronic) Category 2


-
H411 P273
P391
P501
Reliable chronic toxicity data were not obtained. It was classified in Category 2 because it is not rapidly degradable (BIOWIN), and it was classified in Category 2 in acute 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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