The following Pesticide Hazard Tricolour (PHT) alerts are based on the data in the tables below. An absence of an alert does not imply the substance has no implications for human health, biodiversity or the environment but just that we do not have the data to form a judgement. The alerts for Highly Hazardous Pesticides (HHPs) are based on applying the FAO/WHO (Type 1) and the PAN (Type II) criteria to PPDB data. Further details on the HHP indicators are given in the tables below. Neither the PHT nor the HHP hazard alerts take account of usage patterns or exposure, thus they do not represent risk.
PHT: Environmental fate
PHT: Ecotoxicity
PHT: Human health
Highly Hazardous Pesticide
Environmental fate Moderate alert: Potential for particle bound transport: Medium
Human health Moderate alert: Reproduction/development effects
Highly Hazardous Pesticide (HHP) Type II alert
GENERAL INFORMATION
Description
A natural fermentation-derived substance with activity against a wide range of common insect pests
Example pests/issues controlled
Apple moth; Grapevine moth; Codling moth; Oriental fruit moth; Western flower thrip; Pear & cherry slugs
Example applications
Fruit including grapes, apples, pears, apricots, cherries, plums, peaches
Efficacy & activity
-
Appearance and life cycle
-
Taxonomic classification
-
GB regulatory status
GB COPR regulatory status
Not approved
Date COPR inclusion expires
Withdrawn
GB LERAP status
No UK approval for use as a plant protection agent
EC Regulation 1107/2009 (repealing 91/414)
EC Regulation 1107/2009 status
Not approved
Dossier rapporteur/co-rapporteur
Croatia/Spain
Date EC 1107/2009 inclusion expires
-
EU Candidate for substitution (CfS)
No
Listed in EU database
Yes
Approved for use (✓) under EC 1107/2009 in the following EU Member States
ATAustria
BEBelgium
BGBulgaria
CYCyprus
CZCzech Republic
DEGermany
DKDenmark
EEEstonia
ELGreece
✓
✓
✓
✓
ESSpain
FIFinland
FRFrance
HRCroatia
HUHungary
IEIreland
ITItaly
LTLithuania
LULuxembourg
✓
✓
✓
✓
✓
LVLatvia
MTMalta
NLNetherlands
PLPoland
PTPortugal
RORomania
SESweden
SISlovenia
SKSlovakia
✓
✓
✓
✓
Approved for use (✓) under EC 1107/2009 by Mutual Recognition of Authorisation and/or national regulations in the following EEA countries
ISIceland
NONorway
Additional information
Also used in
USA (pending)
Chemical structure
Isomerism
Spinetoram J is the major component of spinetoram technical material. It is not an isomer of spinetoram but contains an extra methyl group.
R04 Rule 4: Pesticide active ingredients that meet the criteria of reproductive toxicity Categories 1A and 1B of the Globally Harmonized System on Classification and Labelling of Chemicals (GHS) (those with a CLP classification of H360)
Example manufacturers & suppliers of products using this active now or historically
Dow AgroSciences
BOC Sciences
Example products using this active
Formulation and application details
Spinetoram J is not formulated as a standalone, isolated product, but rather as the major component (roughly 3:1 ratio with spinetoram L) in the technical material and commercial pesticide formulations.
Commercial production
Spinetoram J is not manufactured through a single chemical synthesis but through a semi synthetic upgrade of natural spinosyns produced by Saccharopolyspora spinosa. The process begins with microbial fermentation, where a genetically modified strain is engineered to block a specific O methylation step, causing the organism to accumulate the precursor 5,6 dihydrospinosyn J. This fermentation product is then subjected to selective chemical modification, most notably 3′ O ethylation, to yield spinetoram J as one of the two active components of commercial spinetoram. The resulting semi synthetic molecule is purified to agrochemical grade and blended with spinetoram L to form the final insecticidal active ingredient.
Solubility - In organic solvents at 20 °C (mg l⁻¹)
250000
A5 A = EU regulatory and evaluation data as published by EC, EFSA (RAR, DAR & Conclusion dossiers), EMA (e.g. EU Annex III PIC DGD) (EU - Pesticides database; EFSA Scientific Publications ) 5 = Verified data used for regulatory purposes
Methanol
-
250000
A5 A = EU regulatory and evaluation data as published by EC, EFSA (RAR, DAR & Conclusion dossiers), EMA (e.g. EU Annex III PIC DGD) (EU - Pesticides database; EFSA Scientific Publications ) 5 = Verified data used for regulatory purposes
Acetone
-
250000
A5 A = EU regulatory and evaluation data as published by EC, EFSA (RAR, DAR & Conclusion dossiers), EMA (e.g. EU Annex III PIC DGD) (EU - Pesticides database; EFSA Scientific Publications ) 5 = Verified data used for regulatory purposes
Xylene
-
61000
A5 A = EU regulatory and evaluation data as published by EC, EFSA (RAR, DAR & Conclusion dossiers), EMA (e.g. EU Annex III PIC DGD) (EU - Pesticides database; EFSA Scientific Publications ) 5 = Verified data used for regulatory purposes
n-Heptane
-
Melting point (°C)
75
E4 E = Manufacturers safety data sheets 4 = Verified data
-
Boiling point (°C)
803.5
E4 E = Manufacturers safety data sheets 4 = Verified data
-
Degradation point (°C)
-
-
-
Flashpoint (°C)
-
-
-
Octanol-water partition coefficient at pH 7, 20 °C
P
1.23 X 1004
Calculated
-
Log P
4.09
A5 A = EU regulatory and evaluation data as published by EC, EFSA (RAR, DAR & Conclusion dossiers), EMA (e.g. EU Annex III PIC DGD) (EU - Pesticides database; EFSA Scientific Publications ) 5 = Verified data used for regulatory purposes
A5 A = EU regulatory and evaluation data as published by EC, EFSA (RAR, DAR & Conclusion dossiers), EMA (e.g. EU Annex III PIC DGD) (EU - Pesticides database; EFSA Scientific Publications ) 5 = Verified data used for regulatory purposes
EU 2013 dossier (spinetoram): Lab studies DT₅₀ range 5-86.9 days, DT₉₀ range 27.1-420.0 days, additional study 72881 days; Field studies XDE-175-J: DT₅₀ range 0.03-2.49 days, DT₉₀ 1.6-25.7, XDE-175-L: DT₅₀ range 0.07-2.0, DT₉₀ range 0.51-7.91 days; Manufacturer published data gives field studies DT₅₀ 3-5 days, lab studies DT₅₀ 13-21 days
Soil mineralisation
Aerobic (at 20 °C)
-
-
-
Anaerobic (at 20 °C)
-
-
Dissipation rate RL₅₀ (days) on plant matrix
Value
-
-
-
Note
-
Dissipation rate RL₅₀ (days) on and in plant matrix
As this parameter is not normally measured directly, a surrogate measure is used: ‘Photochemical oxidative DT₅₀’. Where data is available, this can be found in the Fate Indices section below.
Decay in stored produce DT₅₀
-
Soil adsorption and mobility
Property
Value
Source; quality score; and other information
Interpretation
Linear
Kd (mL g⁻¹)
37.3
E4 E = Manufacturers safety data sheets 4 = Verified data
Non-mobile
Koc (mL g⁻¹)
22836
Notes and range
EU 2013 dossier (spinetoram): Kd range 12-61 mL g⁻¹, Koc range 1470-5490, Soils=10; Manufacturer published data Koc = 1800-43873 mL g⁻¹
Note: These RTLs have been calculated using the regulatory approach used in the European Union and based on ecotoxocity values in the PPDB.
Species group
RTL
Notes
Mammals
No data
No data for acute and chronic mammals
Birds
No data
No data for acute and chronic birds
Soil organisms
No data
No data for acute and chronic earthworms
Terrestrial plants
No data
No data for non-target plants vegetative vigour and seedling emergence
Pollinators
No data
No data for contact and oral honeybees
Arthropods
No data
No data for parasitic wasps and predatory mites
Fish
No data
No data for temperate acute and chronic fish
Aquatic invertebrates
No data
No data for temperate acute and chronic aquatic invertebrates
Aquatic plants
No data
No data for free-floating plants, rooted plants, acute and chronic algae
HUMAN HEALTH AND PROTECTION
General
Property
Value
Source; quality score; and other information
Interpretation
Threshold of Toxicological Concern (Cramer Class)
High (class III)
-
-
Mammals - Acute oral LD₅₀ (mg kg⁻¹)
-
-
-
Mammals - Short Term Oral NOAEL (mg kg⁻¹ bw d⁻¹)
-
-
-
Mammals - Long Term (Chronic) Oral NOAEL (mg kg⁻¹ bw d⁻¹)
-
-
-
Mammals - Dermal LD₅₀ (mg kg⁻¹ body weight)
> 5000
A5 A = EU regulatory and evaluation data as published by EC, EFSA (RAR, DAR & Conclusion dossiers), EMA (e.g. EU Annex III PIC DGD) (EU - Pesticides database; EFSA Scientific Publications ) 5 = Verified data used for regulatory purposes
Rat
-
Mammals - Inhalation LC₅₀ (mg l⁻¹)
> 5.0
A5 A = EU regulatory and evaluation data as published by EC, EFSA (RAR, DAR & Conclusion dossiers), EMA (e.g. EU Annex III PIC DGD) (EU - Pesticides database; EFSA Scientific Publications ) 5 = Verified data used for regulatory purposes
Rat 4 hr
-
Other Mammal toxicity endpoints
-
-
-
ADI - Acceptable Daily Intake (mg kg⁻¹ bw day⁻¹)
0.025
A5 A = EU regulatory and evaluation data as published by EC, EFSA (RAR, DAR & Conclusion dossiers), EMA (e.g. EU Annex III PIC DGD) (EU - Pesticides database; EFSA Scientific Publications ) 5 = Verified data used for regulatory purposes
as spinetoram
-
ARfD - Acute Reference Dose (mg kg⁻¹ bw day⁻¹)
0.1
A5 A = EU regulatory and evaluation data as published by EC, EFSA (RAR, DAR & Conclusion dossiers), EMA (e.g. EU Annex III PIC DGD) (EU - Pesticides database; EFSA Scientific Publications ) 5 = Verified data used for regulatory purposes
A5 A = EU regulatory and evaluation data as published by EC, EFSA (RAR, DAR & Conclusion dossiers), EMA (e.g. EU Annex III PIC DGD) (EU - Pesticides database; EFSA Scientific Publications ) 5 = Verified data used for regulatory purposes
as spinetoram
-
Dermal penetration studies (%)
5-11
A5 A = EU regulatory and evaluation data as published by EC, EFSA (RAR, DAR & Conclusion dossiers), EMA (e.g. EU Annex III PIC DGD) (EU - Pesticides database; EFSA Scientific Publications ) 5 = Verified data used for regulatory purposes
concentration dependent
-
Dangerous Substances Directive 76/464
-
-
-
Exposure Routes
Public
Acceptable for proposed uses
Occupational
Acceptable for proposed uses
Mammalian dose elimination route and rate
85% eliminated via the faeces majority of which is lost in the first 24hrs
A5 A = EU regulatory and evaluation data as published by EC, EFSA (RAR, DAR & Conclusion dossiers), EMA (e.g. EU Annex III PIC DGD) (EU - Pesticides database; EFSA Scientific Publications ) 5 = Verified data used for regulatory purposes
-
Health issues
Specific human health issues (hazard-based)
Carcinogen
Genotoxic
Endocrine disruptor
XNo, known not to cause a problem
A3 A = Chromosome aberration (EFSA database) 3 = Negative
;
B0 B = DNA damage/repair (EFSA database) 0 = No data
;
C3 C = Gene mutation (EFSA database) 3 = Negative
;
D0 D = Genome mutation (EFSA database) 0 = No data
;
E3 E = Unspecified genotoxicity type (miscellaneous data source) 3 = Negative
XNo, known not to cause a problem
Reproduction / development effects
Acetyl cholinesterase inhibitor
Neurotoxicant
?Possibly, status not identified
XNo, known not to cause a problem
XNo, known not to cause a problem
Respiratory tract irritant
Skin irritant
Skin sensitiser
No data found
?Possibly, status not identified
✓Yes, known to cause a problem
Eye irritant
Phototoxicant
?Possibly, status not identified
No data found
General human health issues
Potential for slow accumulation in the body Possible thyroid toxicant Weak sensitiser
Handling issues
Property
Value and interpretation
General
Not explosive or oxidising Not expected to auto-ignite; Not highly flammable
Lewis, K.A., Tzilivakis, J., Warner, D. and Green, A. (2016) An international database for pesticide risk assessments and management. Human and Ecological Risk Assessment: An International Journal, 22(4), 1050-1064. DOI: 10.1080/10807039.2015.1133242
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Environmental fate
Highly Hazardous Pesticide (HHP)
