Staff advice on application for approval Aug 2018.pdf

STAFF ADVICE

APP203594 – Foamstream V4
Substance database ID - 49336

August 2018

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Staff advice on application for approval to import or manufacture Foamstream V4 for release (APP203594)

1. Executive Summary
1.1
Foamstream V4 is a foam concentrate enhancing the herbicidal properties of hot water. It is intended
to be used in purpose-built machines to be delivered on target plants.
1.2
The applicant intends to import Foamstream V4 and supply it to professional users.
1.3
Foamstream V4 has the following hazard classifications: 6.3B, 8.3A and 9.1D.
1.4
With controls in place, the risks to human health and the environment are negligible.
2. Application Context
Background
2.1
Foamstream V4 is a soluble concentrate containing sugars of decyloctylglycosides
and C10
to C16 chain length even-numbered alkyl glycosides
as the surfactant foaming agents, plus
other components. It is intended for use as a herbicide for the control of weeds, moss, and algae in
publicly accessible areas such as cobble and streets, pavements, monuments, street furniture, parks,
schools, waterways (waste water site filter-beds, clean water sites), and artificial surfaces (astro-turf
and rubber playgrounds/ pitches).
2.2
The sugars of decyloctylglycosides and C10 to C16 chain length even-numbered alkyl glycosides are
the “active components” in Foamstream V4 because of their properties as surfactant foaming agents.
They generate a foam during the application process (delivered by a purpose-built machine, the foam
itself contains 0.5% of Foamstream V4), which in combination with a jet of hot water, blankets the
weeds thus exposing them to heat for a longer period than without the foam.
2.3
Foamstream V4 has herbicidal properties through a non-toxic mode of action. The herbicidal effect
comes from the prolonged heat of the foam.
2.4
The composition of Foamstream V4 is considered confidential by the applicant.
2.5
A category A assessment of Foamstream V4 is appropriate because there are no reference
substances to process this application as a rapid. A category A is proposed because a qualitative risk
assessment is deemed sufficient given the use pattern, the non-toxic mode of action, the non-
dispersive way Foamstream V4 will be applied and the high dilution factor of the applied substance.
Surfactant foaming agents
2.6
To allow evaluation of Foamstream V4, key aspects of decyloctylglycosides and C10 to C16 chain
length even-numbered alkyl glycosides regulation have been summarised below.

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Staff advice on application for approval to import or manufacture Foamstream V4 for release (APP203594)

Regulatory status
Table 1 Surfactant foaming agents’ regulatory status
Name
Regulatory status and
International regulatory status and history
history in New Zealand
(Australia, Canada, Europe, Japan, USA)
Decyloctylglycosides
Approved HSR003148
Approved in Europe, Canada, Australia, Japan
and the USA
(CAS 68515-73-1)
C10 to C16 chain length
Not classified as hazardous
Approved in Europe, Canada, Australia, Japan
even-numbered alkyl
in New Zealand
and the USA
glycosides
(CAS 110615-47-9)
2.7
The surfactant “decyloctylglycosides” has previously been approved in New Zealand for use in the
formulation of a pesticide or veterinary medicine. It has also been approved internationally. In Europe
it can be found in the following products: washing & cleaning products, fertilisers, and plant protection
products (information from European Chemicals Agency, ECHA).
2.8
The surfactant “C10 to C16 chain length even-numbered alkyl glycosides” has no hazardous
classification in New Zealand. In Europe it can be found in the following products: washing & cleaning
products and plant protection products (information from ECHA).
2.9
The Pesticide Management Regulatory Agency (Canada), European authorities (Denmark, Finland,
Poland, Switzerland and United Kingdom), the Washington EPA and the California EPA have
exempted Foamstream V4 from registration.
Physical form and use pattern
2.10   Foamstream V4 is formulated as a soluble concentrate.
2.11  Foamstream V4 is delivered by a purpose-built machine. This machine delivers foam on the target
plants by means of specialised applicator heads and heats up the foam at 95-110 °C.
2.12  Foamstream V4 concentrate is loaded in the machine and is diluted to deliver a 0.5% foam spray. The
Foamstream V4 contributes to generating a stable foam onto the target, thus acting as a foam blanket
to entrap the hot water around the weed for much longer than plain hot water. This results in a higher
kill rate for the target weeds. The heat in the hot water is responsible for killing the weeds, whilst
Foamstream V4 merely acts as an insulator to retain the heat.
2.13  The intended use of Foamstream V4 is as a herbicide on a variety of public spaces. The use pattern is
summarised in Table 2.

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Staff advice on application for approval to import or manufacture Foamstream V4 for release (APP203594)

Table 2 Summary of use pattern for Foamstream V4
Wide
Application
Substance category
dispersive
Home use?
Concentration
Remarks
rate(s)
use?
The foam is
Biocide
Yes  ☐ No ☒
Yes  ☐ No ☒
NA

diluted to 0.5%
3. Hazard Assessment
Hazard classification of Foamstream V4
3.1
The hazard classifications of Foamstream V4 determined by the EPA staff are: 6.3B, 8.3A and 9.1D.
Table 3 shows the method used for classification and indicates the main component that contributes to
each hazard classification.
3.2
The EPA staff classification of Foamstream V4 differed from that of the applicant in that it has an
additional 9.1D classification. This is because the intended use of Foamstream V4 is as a biocide.
Table 3 Hazard classification of Foamstream V4
Method of

Mixture classification

classification

1
s
s
Applicant’s
EPA
ta
s
le
Hazard Class/Subclass
a

d
ro
ru
Remarks
classification
classification
c
re
a
re
tu
d
tu
x
a
e
x
Mi
R
Mi
Class 1 Explosiveness
NA
No
☐
☐  ☒

Class 2, 3 & 4 Flammability
NA
No
☐
☐  ☒

Class 5 Oxidisers/Organic
NA
ND
☐
☐  ☒

Peroxides
8.1 Metallic corrosiveness
NA
ND
☐
☐  ☒

6.1 Acute toxicity (oral)
NA
No
☐
☐  ☒

6.1 Acute toxicity (dermal)
NA
No
☐
☐  ☒

6.1 Acute toxicity (inhalation)
NA
ND
☐
☐  ☒

6.1 Aspiration hazard
NA
ND
☐
☐  ☒

6.3 Skin irritancy
6.3B
6.3B
☐
☐  ☒
Citric acid
Decyloctylglycosides,
8.3 Eye corrosion
8.3A
8.3A
☐
☐  ☒
C10 to C16 chain length
even-numbered alkyl
glycosides and citric

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Staff advice on application for approval to import or manufacture Foamstream V4 for release (APP203594)

Method of

Mixture classification

classification

1
s
s
Applicant’s
EPA
ta
s
a
le
Hazard Class/Subclass
d
ro
ru
Remarks
classification
classification
c
re
a
re
tu
d
tu
x
a
e
x
Mi
R
Mi
acid, see comment in
section 3.3
6.5A Respiratory sensitisation
NA
ND
☐
☐  ☒

6.5B Contact sensitisation
NA
ND
☐
☐  ☒

6.6 Mutagenicity
NA
ND
☐
☐  ☒

6.7 Carcinogenicity
NA
ND
☐
☐  ☒

6.8 Reproductive/ developmental
NA
ND
☐
☐  ☒

toxicity
6.8 Reproductive/ developmental
NA
ND
☐
☐  ☒

toxicity (via lactation)
6.9 Target organ systemic toxicity
NA
ND
☐
☐  ☒

Classification is based
9.1 Aquatic ecotoxicity
NA
9.1D
☐
☐  ☐
on the biocidal action
of the substance
9.2  Soil ecotoxicity
NA
ND
☐
☐  ☒

9.3 Terrestrial vertebrate ecotoxicity
NA
ND
☐
☐  ☒

9.4  Terrestrial invertebrate
NA
ND
☐
☐  ☒

ecotoxicity

-:  No information provided by the applicant
NA: Not Applicable. For instance, testing for a specific endpoint may be omitted if it is technically not possible to conduct the
study as a consequence of the properties of the substance e.g. highly volatile, highly reactive or unstable substances cannot
be tested; mixing of the substance with water may cause danger of fire or explosion; or the radio-labelling of the substance
required in certain studies may not be possible.

ND: Not Determined. Data were unavailable for one or more components.

No: Data are available for the formulation or for all components and classification is not triggered.
1 Use of mixture rules may not adequately take into account interactions between different components in some
circumstances and must be considered of lower reliability than data on the mixture itself.
2 Klimisch, H-J., Andrear, M., & U. Tillmann, 1997. A systematic approach for evaluating the quality of experimental
toxicological and ecotoxicological data. Reg. Toxicol. Pharmacol. 25, 1–5 (1997)
3.3
The EPA database contains very little information on the two surfactant foaming agents in
Foamstream V4, therefore the classification is based on the Safety Data Sheets of the surfactants
which have been cross-referenced to data available on ECHA.

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Staff advice on application for approval to import or manufacture Foamstream V4 for release (APP203594)



4. Risk Assessment
Human health risk assessment
4.1
Foamstream V4 is intended to be supplied to the professional markets. Users are expected to load the
substance in the machine (the machine dilutes the substance in hot water) and apply the diluted
substance (the foam) using specialised spray equipment. It is likely that users will be exposed to the
substance during loading of Foamstream V4 in the machine and to the diluted foam when applying the
substance. The public could also be exposed to the foam.
Skin irritancy (6.3B)
4.2
It is likely that skin exposure may occur during the loading of this substance by the users, but any
effect is expected to be minor and reversible. The prescribed HSW (HS) requirements include
requirements for Personal Protective Equipment (PPE) and as such the risk from the skin irritancy
hazard for users is assessed to be negligible.
4.3
It is likely that skin exposure may occur if members of the public are in contact with the foam, but any
effect is expected to be negligible because the foam is diluted so that it is no longer irritant.
Eye corrosivity (8.3A)
4.4
It is unlikely that eye exposure may occur during the loading of this substance by the users, and any
effect is expected to be major and irreversible. The prescribed HSW (HS) requirements include
requirements for PPE and as such the residual risk from the eye corrosivity hazard has been
assessed as being negligible.
Environmental risk assessment
4.5
Foamstream V4 is intended for use as a herbicide for the control of weeds, moss, and algae in publicly
accessible areas such as cobble and streets, pavements, monuments, street furniture, parks, schools,
waterways (waste water site filter-beds, clean water sites), and artificial surfaces (astro-turf and rubber
playgrounds/ pitches).

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Staff advice on application for approval to import or manufacture Foamstream V4 for release (APP203594)

Biocidal effect
4.6
It is unlikely that non-target organisms will be exposed to Foamstream V4, because the application by
means of specialised applicator heads will minimize spray drift, run off and exposure of non-target
sensitive areas.
4.7
Once applied, Foamstream V4 quickly loses its biocidal properties with the cooling down of the foam.
Furthermore, the surfactant foaming agents and other components of Foamstream V4 are all rapidly
degradable, therefore, should the diluted substance enter waterways or other environmental
compartments, no significant effect on aquatic organisms, soil-dwelling organisms, and terrestrial
vertebrates and invertebrates is expected.
4.8
It is unlikely that the foam, once applied to weeds, will be attractive to bees, other pollinators or other
non-target organisms because the sugars in the foam are diluted to 0.5%.
4.9
The prescribed controls include requirements to avoid adverse effects to the environment beyond the
application area (Clause 46 of the HPC Notice) and to not apply the substance to water (Clause 52 of
the HPC Notice).
4.10  The application of Foamstream V4 by a purpose-built machine is key in reducing the exposure to the
environment. It is therefore necessary to apply an additional control to restrict the use of Foamstream
V4 to the appropriate equipment (Clause 47 of the HPC Notice): the Foamstream Municipal machine.
Risk assessment conclusion
4.11  Risks during other phases of the lifecycle are also mitigated by the prescribed controls.
4.12  With the proposed controls in place, the residual risks of the use of Foamstream V4 are negligible.

5. Controls
Prescribed controls
5.1
The hazard classifications of Foamstream V4 determine a set of prescribed controls specified by the
EPA Notices. There are also requirements in the Health and Safety at Work (Hazardous Substance,
HSW (HS)) Regulations under the HSW Act.
5.2
The prescribed controls set the baseline for how the substance should be managed and include
specifications on how the substance is to be packaged, labelled, stored, disposed of, transported,
handled and used. The prescribed controls also set information requirements (eg Safety Data Sheets),
signage and emergency management.
Labelling and identification
5.3
The name and concentration of the following components need to be specified on the label and SDS:

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Staff advice on application for approval to import or manufacture Foamstream V4 for release (APP203594)

Table 4 List of components requiring identification
Label
SDS
Citric acid (8.3A)
Citric acid (8.3A)
D-Glucopyranose, oligomeric, decyl octyl glycosides
D-Glucopyranose, oligomeric, decyl octyl glycosides
(8.3A)
(8.3A)
D-Glucopyranose, oligomeric, C10-16-alkyl
D-Glucopyranose, oligomeric, C10-16-alkyl glycosides
glycosides (8.3A)
(8.3A)
Exposure limits
5.4
No TEL (Tolerable Exposure Limit) has been set because it is considered that exposure to this
substance is not likely to result in an appreciable toxic effect to people, provided conditions of use are
followed.
5.5
No Environmental Exposure Limit (EEL) values have been set previously for the surfactant foaming
agents in Foamstream V4. Exposure to the environment is not expected, provident conditions of use
are followed.
Maximum application rate
5.6
No maximum application rate is required because this substance is not used in a wide dispersive way.
Additional controls
Equipment
5.7
This substance must only be applied with the Foamstream Municipal machine.

6. Conclusion
6.1
After taking into account the prescribed controls and any variations to these controls, it was concluded
that the residual level of risk of any potentially significant adverse effects is negligible.

August 2018