BETWEEN

XXX (hereafter Supplier)

and

ABC Australia Pty Ltd of 1234567, Elsewhere, Qld 4444, Australia (hereafter Introducer)

This joint understanding is made on __________________ by the undersigned officers of both Supplier and Introducer

REGARDING

Amyl ethyl ether

Supplier

Name/signature

Witness/signature

Introducer

Name/signature

Witness/signature

WHEREAS

The Act

The Australian Industrial Chemicals Introduction Scheme (hereafter AICIS) operates in the Office of Chemical Safety in the Commonwealth of Australia, Department of Health and which Scheme is administered by the Executive Director pursuant to the Industrial Chemicals Act (2019) (hereafter the Act) and the Industrial Chemicals (General) Rules 2019.

Introducer

An Introducer must be registered with AICIS before introducing an industrial chemical during that year. Penalties apply if a person introduces an industrial chemical without being registered.

Executive Director

The Executive Director has monitoring, inspection and enforcement powers including civil penalty provisions and the use of infringement notices, enforceable undertakings and injunctions under the Regulatory Powers Act to ensure the Act is being complied with.

Failure to provide information

Failure to provide requested information contravenes the Act if the chemical has been introduced. The Act provides for penalties if introductions are not authorised. Any penalty under the Act prevents the Introducer from registering as an Introducer for three years.

Protected information

The Act (Section 115 Disclosing information) applies to protected information. Protected information means the Introducer and/or the Supplier have applied to the Executive Director to keep business information confidential.

Requested information

Information specified for Amyl ethyl ether which may be requested by the Executive Director depends upon those health/environment hazards and exposure/release characteristics which, together with how the chemical will be used, determined its categorisation of Reported - low risk .

Information requested may include some or all of the following:

Environment info required for AICIS: Persistent bioaccumulative and toxic: Log Kow

A suitable in-silico prediction for partition coefficient of the chemical itself of log Kow <4.2 (that is not negated by a measured log Kow) or

a measured value from a study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for partition coefficient for which log Kow <4.2

Acceptable tests (or alternatives)

Environment info required for AICIS: Very toxic to any aquatic life

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 >1 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 >0.1 mg/L (for chemicals that are not readily biodegradable)

Acceptable tests (or alternatives)

Health info required for AICIS: Genetic toxicity: GRAS substances

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

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

test results that demonstrate the absence of mutagenic or genotoxic effects from both:
- study on the chemical or from suitable read across information conducted following an acceptable test guideline for gene mutation, and
- study on the chemical or from suitable read across information conducted following an acceptable test guideline for chromosomal abnormalities.

Acceptable tests (or alternatives)

Health info required for AICIS: Skin corrosion

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.

Acceptable tests (or alternatives)

Health info required for AICIS: Eye damage

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

Acceptable tests (or alternatives)

Health info required for AICIS: Skin sensitisation

Results from a defined approach (combination of tests) described in Acceptable tests (or alternatives)

Health info required for AICIS: Acute toxicity (fatal or toxic)

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

Acceptable tests (or alternatives)

Health info required for AICIS: STOT after repeated exposure: > 1,000 kg

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 subacute oral toxicity, in which the NOAEL (oral) is ≥300 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

- conducted following an acceptable test guideline for subchronic oral toxicity, in which the NOAEL (oral) is ≥100 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

- conducted following an acceptable test guideline for subacute dermal toxicity, in which the NOAEL (dermal) is ≥600 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

- conducted following an acceptable test guideline for subchronic dermal toxicity, in which the NOAEL (dermal) is ≥200 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

- conducted following an acceptable test guideline for subacute inhalation toxicity, in which there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or the NOAEC (inhalation) is:
- for gases - ≥750 ppmV/6 h/day, or
- for vapours - ≥3 mg/L/6 h/day, or
- for dusts/mists/fumes - ≥0.6 mg/L/6 h/day, or

- conducted following an acceptable test guideline for subchronic inhalation toxicity, in which there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or the NOAEC (inhalation) is:
- for gases - ≥250 ppmV/6 h/day, or
- for vapours - ≥1 mg/L/6 h/day, or
- for dusts/mists/fumes - ≥0.2 mg/L/6 h/day.

Acceptable tests (or alternatives)