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You will need to contact AICIS for guidance on the additional information you must include in your application regarding the following Specified class:

Polyhalogenated organic chemical

This requirement is detailed at ...

https://www.industrialchemicals.gov.au/business/apply-assessment-certificate

3.5.2 Formulation or re-packing

At least one use (use name) must be provided in either 3.5.2, 3.5.3, 3.5.4 or 3.5.5.

Refer to 'Guide to applying online for an assessment certificate – Manufacture, use and exposure'.

https://www.industrialchemicals.gov.au/help-and-guides/guide-applying-online-assessment-certificate

3.5.3 Uses at industrial sites

At least one use (use name) must be provided in either 3.5.2, 3.5.3, 3.5.4 or 3.5.5.

Refer to 'Guide to applying online for an assessment certificate – Manufacture, use and exposure'.

https://www.industrialchemicals.gov.au/help-and-guides/guide-applying-online-assessment-certificate

3.5.4 Widespread uses by professional workers

At least one use (use name) must be provided in either 3.5.2, 3.5.3, 3.5.4 or 3.5.5.

Refer to 'Guide to applying online for an assessment certificate – Manufacture, use and exposure'.

https://www.industrialchemicals.gov.au/help-and-guides/guide-applying-online-assessment-certificate

3.5.5 Consumer uses

At least one use (use name) must be provided in either 3.5.2, 3.5.3, 3.5.4 or 3.5.5.

Refer to 'Guide to applying online for an assessment certificate – Manufacture, use and exposure'.

https://www.industrialchemicals.gov.au/help-and-guides/guide-applying-online-assessment-certificate

3.5.6 Article service life

4.9 Solubility in organic solvents / fat solubility

4.10 Surface tension

4.16 Oxidation reduction potential

4.20 pH

4.22 Viscosity

4.23 Self-reactive substances

4.27 Additional physico-chemical information

4.28.1 Nanomaterial agglomeration / aggregation

4.28.2 Nanomaterial crystalline phase

4.28.3 Nanomaterial crystallite and grain size

4.28.4 Nanomaterial aspect ratio / shape

4.28.5 Nanomaterial specific surface area

4.28.6 Nanomaterial Zeta potential

4.28.7 Nanomaterial surface chemistry

4.28.8 Nanomaterial dustiness

4.28.9 Nanomaterial porosity

4.28.10 Nanomaterial pour density

4.28.11 Nanomaterial photocatalytic activity

4.28.12 Nanomaterial radical formation potential

4.28.13 Nanomaterial catalytic activity

4.28.14 Nanomaterial dispersion stability

5.1.1 Phototransformation in air

5.1.3 Phototransformation in water

5.2.3 Biodegradation in soil

5.4.2 Henry’s Law constant

5.4.4 Other distribution data

5.6 Additional information on environmental fate and behaviour

6.1.2 Long-term toxicity to fish

6.1.4 Long-term toxicity to aquatic invertebrates

6.1.6 Toxicity to aquatic plants other than algae

6.1.7 Toxicity to microorganisms

6.1.8 Endocrine disruptor testing in aquatic vertebrates – in vivo

6.1.9 Toxicity to other aquatic vertebrates

6.2 Sediment toxicity

6.3.1 Toxicity to soil macroorganisms except arthropods

6.3.2 Toxicity to terrestrial arthropods

6.3.3 Toxicity to terrestrial plants

6.3.4 Toxicity to soil microorganisms

6.6 Additional ecotoxicological information

7.1.1 Basic toxicokinetics

7.1.2 Dermal absorption

7.2.4 Acute toxicity: other routes

7.4.2 Respiratory sensitisation

7.5.4 Repeated dose toxicity: other routes

7.7 Carcinogenicity

7.8.1 Toxicity to reproduction

7.8.2 Developmental toxicity / teratogenicity

7.8.3 Toxicity to reproduction: other studies

7.9.1 Neurotoxicity

7.9.2 Immunotoxicity

7.9.4 Specific investigations: other studies

7.10.1 Health surveillance data

7.10.2 Epidemiological data

7.10.3 Direct observations: clinical cases, poisoning incidents and other observations

7.10.4 Sensitisation data (humans)

7.10.5 Exposure related observations in humans: other data

7.12 Additional toxicological information

9. Residues in food and feeding stuff

1.1 Identification

1.2 Composition

1.4 Analytical information

2.1 GHS

3.2 Estimated quantities

3.3 Site

For manufacture only

3.5.1 Manufacture

For manufacture only

4.1 Appearance / physical state / colour

4.2 Melting point / freezing point

4.3 Boiling point

4.4 Density

4.5 Particle size distribution (Granulometry)

4.6 Vapour pressure

4.7 Partition coefficient

4.8 Water solubility

4.11 Flash point

4.12 Auto flammability

4.13 Flammability

4.14 Explosiveness

4.15 Oxidising properties

4.21 Dissociation constant

5.1.2 Hydrolysis

5.2.1 Biodegradation in water: screening tests

5.3.1 Bioaccumulation: aquatic / sediment

Information on either 5.3.1 or 5.3.2

5.3.2 Bioaccumulation: terrestrial

Information on either 5.3.1 or 5.3.2

5.4.1 Adsorption / desorption

6.1.1 Short-term toxicity to fish

6.1.3 Short-term toxicity to aquatic invertebrates

6.1.5 Toxicity to aquatic algae and cyanobacteria

7.2.1 Acute toxicity: oral

Information on either 7.2.1, 7.2.2 or 7.2.3.

7.2.2 Acute toxicity: inhalation

Information on either 7.2.1, 7.2.2 or 7.2.3.

7.2.3 Acute toxicity: dermal

Information on either 7.2.1, 7.2.2 or 7.2.3.

7.3.1 Skin irritation / corrosion

7.3.2 Eye irritation

7.4.1 Skin sensitisation

7.5.1 Repeated dose toxicity: oral

Required (information on either 7.5.1, 7.5.2 or 7.5.3)

7.5.2 Repeated dose toxicity: inhalation

Required (information on either 7.5.1, 7.5.2 or 7.5.3)

7.5.3 Repeated dose toxicity: dermal

Required (information on either 7.5.1, 7.5.2 or 7.5.3)

7.6.1 Genetic toxicity in vitro

Information on point mutations (7.6.1 or 7.6.2) and chromosome damage (7.6.1 or 7.6.2)

7.6.2 Genetic toxicity in vivo

Information on point mutations (7.6.1 or 7.6.2) and chromosome damage (7.6.1 or 7.6.2)

11. Guidance on safe use

13. Assessment report (attach SDS here)

Information on aquatic toxicity for all three trophic levels (fish, invertebrates and algae) from suitable in silico predictions on the chemical or in vivo studies on the chemical or from suitable read across information, conducted following acceptable test guidelines for aquatic toxicity, with the following results for all three trophic levels:

- acute aquatic toxicity >10 mg/L (96 h LC50 (fish), or 48 h EC50 (invertebrates) or 72 or 96 h ErC50 (algae)), or

- chronic aquatic toxicity NOEC or EC10 >1 mg/L (for chemicals that are not readily biodegradable)

OECD Test 201: Freshwater Alga and Cyanobacteria, Growth Inhibition Test

(EU Annex V test methods C.3; OCSPP 850.4550; OPPT 797.1050; OPP 122-2; OPP 123-2)

OECD Test 202: Daphnia sp. Acute Immobilisation Test

(ISO 6341; EU Annex V test method C. 2; OCSPP 850.1010; OPP 72-2)

OECD Test 203: Fish, Acute Toxicity Test

(ISO 10229; EU Annex V test method C.1; OCSPP 850.1075; OPP 72-1; OPP 72-3)

OECD Test 210: Fish, Early-life Stage Toxicity Test

(OCSPP 850.1400; EU Annex V test method C.15)

OECD Test 211: Daphnia magna Reproduction Test

(OCSPP 850.1300; EU Annex V test method C.20)

Test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for skin corrosion, with a non-corrosive prediction, or

test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for skin irritation, with a non-irritant prediction, or

test results from an in vivo study on the chemical or from suitable read across information, conducted following an acceptable test guideline for skin irritation, which does not result in destruction of skin tissue, as described for skin corrosion in chapter 3.2 of the GHS.

OECD Test 404: Acute Dermal Irritation/Corrosion

(EU Annex V test method B.4.; OCSPP 870.2500; OPPT 798.4470; OPP 81-5)

OECD Test 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER)

(EU Annex V test method B.43; EURL ECVAM DB-ALM protocol No.115)

OECD Test 431: In vitro skin corrosion: reconstructed human epidermis (RHE) test method

(EU Annex V test method B.40; EURL ECVAM DB-ALM protocols No.118 and 119)

OECD Test 435: In Vitro Membrane Barrier Test Method for Skin Corrosion

(EURL ECVAM DB-ALM protocol No.116)

OECD Test 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method

(EU Annex V test method B.46; EURL ECVAM DB-ALM protocols No.131, 135 and 138)

Test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for eye damage, which predicts the chemical would not induce serious eye damage, or

test results from an in vivo study on the chemical or from suitable read across information, conducted following an acceptable test guideline for eye irritation, which does not result in effects on the eye, as described for eye damage in chapter 3.3 of the GHS

OECD Test 405: Acute Eye Irritation/Corrosion

(EU Annex V test methods B.5; OCSPP 870.2400; OPPT 798.4500; OPP 81-4)

OECD Test 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage

(EU Annex V test method B.47; EURL ECVAM DB-ALM protocols No. 98 and 124)

OECD Test 438: Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage

(EU Annex V test method B.48; EURL ECVAM DB-ALM protocol No. 80)

OECD Test 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants

(EURL ECVAM DB-ALM protocol No. 71)

OECD Test 491: Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage

OECD Test 492: Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage

OECD Test 494: Vitrigel-Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage

Test results from an in chemico test on the chemical or from suitable read-across information, conducted following an acceptable test guideline for the 1st key event in skin sensitisation, with a non-sensitising prediction; and

results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for the 2nd key event in skin sensitisation, with a nonsensitising prediction; and

test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for the 3rd key event in skin sensitisation, with a non-sensitising prediction. OR

Test results from an in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for skin sensitisation, which does not result in induction of an allergic response, as described in chapter 3.4 of the GHS or

information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation

OECD Test 406: Skin Sensitisation

(EU Annex V test method B.6; OCSPP 870.2600; OPPT 798.4100; OPP 81-6)

OECD Test 429: Skin Sensitisation

(EU Annex V test method B.42)

OECD Test 442A: Skin Sensitization

(EU Annex V test method B.50)

OECD Test 442B: Skin Sensitization

(EU Annex V test method B.51)

OECD Test 442C: In Chemico Skin Sensitisation

(EU Annex V test methods B.59; EURL ECVAM DB-ALM protocol No.154)

OECD Test 442D: In Vitro Skin Sensitisation

(EU Annex V test method B.60; EURL ECVAM DB-ALM protocol No.155)

OECD Test 442E: In Vitro Skin Sensitisation

(EURL ECVAM DB-ALM protocol No.158)

Information to demonstrate that the chemical is included on the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion, and that the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or

Information to demonstrate that the chemical has been notified to the US FDA GRAS notification program and FDA had no questions about the notifier's conclusion of GRAS status, and that the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or

the chemical is permitted to be used as a food additive according to Schedule 15 of the Australia New Zealand Food Standards Code - Standard 1.3.1 - Food Additives, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or

a test result from at least one in vivo study on the chemical or from suitable read across information, as detailed below, with the administration route dependent on the most relevant route of exposure (or the oral route if information on the most relevant route is not available):

- conducted following an acceptable test guideline for acute oral toxicity with an LD50 greater than 300 mg/kg bw, or

- conducted following an acceptable test guideline for acute dermal toxicity with an LD50 greater than 1,000 mg/kg bw, or

- conducted following an acceptable test guideline for acute inhalation toxicity, with an LC50:

- for gases - greater than 2,500 ppmV/4h, or

- for vapours - greater than 10 mg/L/4h, or

- for dusts/mists/fumes - greater than 1 mg/L/4h, or

test results from an in vivo study via the oral route on the chemical or from suitable read across information, conducted following an acceptable test guideline for subacute oral toxicity, with a NOAEL greater than or equal to 1,000 mg/kg bw/day

OECD Test 401: Acute Oral Toxicity

(EU Annex V test methods B.1, B.1 bis, B.1 tris; OCSPP 870.1100; OPPT 798.1175; OPP 81-1)

OECD Test 403: Acute Inhalation Toxicity

(EU Annex V test methods B.2 or B.52; OCSPP 870.1300; OPPT 798.1150; OPP 81-3)

OECD Test 420: Acute Oral Toxicity - Fixed Dose Procedure

(EU Annex V test methods B.1, B.1 bis, B.1 tris; OCSPP 870.1100; OPPT 798.1175; OPP 81-1)

OECD Test 423: Acute Oral toxicity - Acute Toxic Class Method

(EU Annex V test methods B.1, B.1 bis, B.1 tris; OCSPP 870.1100; OPPT 798.1175; OPP 81-1)

OECD Test 425: Acute Oral Toxicity: Up-and-Down Procedure

(EU Annex V test methods B.1, B.1 bis, B.1 tris; OCSPP 870.1100; OPPT 798.1175; OPP 81-1)

OECD Test 433: Acute Inhalation Toxicity: Fixed Concentration Procedure

(EU Annex V test methods B.2 or B.52; OCSPP 870.1300; OPPT 798.1150; OPP 81-3)

OECD Test 436: Acute Inhalation Toxicity – Acute Toxic Class Method

(EU Annex V test methods B.2 or B.52; OCSPP 870.1300; OPPT 798.1150; OPP 81-3)