26 April 2006
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
FULL PUBLIC REPORT
Chemical in Crodazosoft DBQThis Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification and Assessment) Act 1989 (Cwlth) (the Act) and Regulations. This legislation is an Act of the Commonwealth of Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is administered by the Department of Health and Ageing, and conducts the risk assessment for public health and occupational health and safety. The assessment of environmental risk is conducted by the Department of the Environment and Heritage.
For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at:
Library
Australian Safety and Compensation Council
25 Constitution Avenue
CANBERRA ACT 2600
AUSTRALIA
To arrange an appointment contact the Librarian on TEL + 61 2 6279 1162 or email
This Full Public Report is available for viewing and downloading from the NICNAS website or available on request, free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS Administration Coordinator at:
Street Address: 334 - 336 Illawarra Road MARRICKVILLE NSW 2204, AUSTRALIA.
Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA.
TEL: + 61 2 8577 8800
FAX + 61 2 8577 8888
Website: www.nicnas.gov.au
Director
NICNAS
TABLE OF CONTENTS
FULL PUBLIC REPORT 4
1. APPLICANT AND NOTIFICATION DETAILS 4
2. IDENTITY OF CHEMICAL 4
3. COMPOSITION 4
4. INTRODUCTION AND USE INFORMATION 5
5. PROCESS AND RELEASE INFORMATION 5
5.1. Distribution, transport and storage 5
5.2. Operation description 5
5.3. Occupational Exposure 5
End use: 6
5.4. Release 6
5.5. Disposal 7
5.6. Public exposure 7
6. PHYSICAL AND CHEMICAL PROPERTIES 7
7. TOXICOLOGICAL INVESTIGATIONS 10
7.1. Irritation – skin – in vitro 10
7.2 Irritation – Eye Irritancy Potential Utilizing the HET-CAM test. 11
7.3 Skin sensitisation – human volunteers – Repeated Insult Patch Test 11
8. ENVIRONMENT 14
8.1. Environmental fate 14
8.1.1. Ready biodegradability 14
8.1.2. Bioaccumulation 14
8.2. Ecotoxicological investigations 14
8.2.1. Acute toxicity to fish 14
8.2.2. Acute toxicity to aquatic invertebrates 15
8.2.3. Algal growth inhibition test 15
9. RISK ASSESSMENT 17
9.1. Environment 17
9.1.1. Environment – exposure assessment 17
9.1.2. Environment – effects assessment 17
9.1.3. Environment – risk characterisation 17
9.2. Human health 18
9.2.1. Occupational health and safety – exposure assessment 18
9.2.2. Public health – exposure assessment 18
9.2.3. Human health – effects assessment 19
9.2.4. Occupational health and safety – risk characterisation 20
9.2.5. Public health – risk characterisation 20
10. CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND HUMANS 20
10.1. Hazard classification 20
10.2. Environmental risk assessment 21
10.3. Human health risk assessment 21
10.3.1. Occupational health and safety 21
10.3.2. Public health 21
11. MATERIAL SAFETY DATA SHEET 21
11.1. Material Safety Data Sheet 21
11.2. Label 21
12. RECOMMENDATIONS 21
12.1. Secondary notification 23
13. BIBLIOGRAPHY 23
File No: STD/110626 April 2006
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
FULL PUBLIC REPORT
Chemical in Crodazosoft DBQThis Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification and Assessment) Act 1989 (Cwlth) (the Act) and Regulations. This legislation is an Act of the Commonwealth of Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is administered by the Department of Health and Ageing, and conducts the risk assessment for public health and occupational health and safety. The assessment of environmental risk is conducted by the Department of the Environment and Heritage.
For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at:
Library
Australian Safety and Compensation Council
25 Constitution Avenue
CANBERRA ACT 2600
AUSTRALIA
To arrange an appointment contact the Librarian on TEL + 61 2 6279 1162 or email
This Full Public Report is available for viewing and downloading from the NICNAS website or available on request, free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS Administration Coordinator at:
Street Address: 334 - 336 Illawarra Road MARRICKVILLE NSW 2204, AUSTRALIA.
Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA.
TEL: + 61 2 8577 8800
FAX + 61 2 8577 8888
Website: www.nicnas.gov.au
Director
NICNAS
26 April 2006 NICNAS
FULL PUBLIC REPORT
Chemical in Crodazosoft DBQ1. APPLICANT AND NOTIFICATION DETAILS
Applicant(s)Croda Singapore Pte Ltd (trading as Croda Australia) (ABN: 34 088 345 457)
Suite A1, Ground Floor,
44-46 Mandarin Street
Villawood NSW 2163
Notification Category
Standard: Chemical other than polymer (more than 1 tonne per year).
Exempt Information (Section 75 of the Act)
Data items and details claimed exempt from publication:
· Import volumes
· Chemical name
· CAS number
· Molecular and structural formulae
· Molecular weight
· Spectral data
· Percentage of notified chemical in final products
Variation of Data Requirements (Section 24 of the Act)
Variation to the schedule of data requirements is claimed as follows:
All toxicological testing
All ecotoxicological testing
Previous Notification in Australia by Applicant(s)
None
Notification in Other Countries
Canada (low level notification under the Food and Drugs Act)
2. IDENTITY OF CHEMICAL
Other Name(s)Quaternium 91 (INCI name)
Marketing Name(s)
Crodazosoft DBQ (notified chemical is component of this mixture)
Methods of Detection and Determination
Method / IR, titration for free amine.
Remarks / Copy of IR spectrum of Crodazosoft DBQ provided.
3. COMPOSITION
Degree of Purity> 80%
4. INTRODUCTION AND USE INFORMATION
Mode of Introduction of Notified Chemical (100%) Over Next 5 YearsThe notified chemical will be imported as 50% of Crodazosoft DBQ.
Maximum Introduction Volume of Notified Chemical (100%) Over Next 5 Years
Year / 1 / 2 / 3 / 4 / 5
Tonnes / < 1 / < 1 / < 1 / < 1 / < 1
Use
Ingredient in hair care products.
5. PROCESS AND RELEASE INFORMATION
5.1. Distribution, transport and storage
Port of EntrySydney
Identity of Manufacturer/Recipients
Manufacturers of hair care products
Transportation and Packaging
The notified chemical will be transported into Australia by ship in 75 kg heat-sealed plastic bags. The notified chemical will be transported from the dockside to the manufacturing site at Hornsby, NSW, where it will be stored and formulated into hair care products. The finished hair care product will be packaged into 250 mL plastic bottles. These plastic bottled products are then packed in cardboard cartons before being transported by truck or van to hairdressing salons or to a port for export.
5.2. Operation description
At the formulation site the hair care products are formulated in batch sizes of 18,000 kg. Crodazosoft DBQ containing 50% of the notified chemical is poured into stainless steel containers filled with solvent for dissolution. The resulting mixture is transferred under vacuum into a second sealed blending vessel where other components of the hair products are added. Prior to packaging, sampling and quality testing of the preparation is carried out in the laboratory. The formulated hair care products are then transferred to a hopper with a multiple head filler machine and automatically poured into 250 mL plastic bottles. The finished hair care products will contain < 1% of the notified chemical.The bottled products will be packed in cardboard cartons and will be exported or sent to distribution centres for hairdressing outlets .
5.3. Occupational Exposure
Number and Category of WorkersCategory of Worker / Number / Exposure Duration / Exposure Frequency
Storage and transport
Transporting from dock to Manufacturer’s site for reformulation (loading/unloading trucks) / 2-4 / 2-3 hours/day / 2 days/year
Manufacture of hair care products:
Formulation, filling containers, cleaning and maintenance
Quality control
Transport and storage of formulated hair care products to end users (hair dressers) / 6
1
2-4 / 8 hours/day
4 hours/day
1-2 hours/day / 72 days/year
20 days/year
150 days/year
End use:
Product application by hairdressers / ~ 1000 / 8 hours/day / 300 days/yearExposure Details
Transport and storage
Warehousing and distribution of the notified chemical involves loading, unloading, moving and storing of packaged notified chemical and packaged hair care products. No exposure is expected except in the case of accident.
Manufacture of hair care products
The mixing vessels are enclosed and the filling machines are automated and fitted with local exhaust ventilation to capture any volatile or aerosol materials at the source. However, dermal and limited ocular exposure may occur when opening and closing the drums and when adding the notified chemical manually into mixing vessel, and connecting and disconnecting transfer and filling lines.
Dermal exposure may also occur due to drips and spills and if containers are overfilled at the filling station. Skin contamination may occur when maintenance workers are cleaning equipment and during maintenance of equipment.
Workers involved in the above activities wear personal protective equipment such as, overalls, safety glasses, safety shoes and PVC or disposable latex gloves.
Quality Control/Maintenance
Limited dermal exposure to small quantities may occur during sampling and testing or during machine maintenance. To minimise exposure workers will wear laboratory coats, safety glasses and rubber gloves.
End-use in hairdressing salons
The bottled products will be sent to distribution centres for storage until distribution to retail or hairdressing outlets. Except in the case of accident, workers handling the finished product during distribution and retail would not be exposed to the notified chemical because of the closed containers, and even in the case of spills, the small packaging size and the low concentration of the notified chemical in the finished products would limit exposure.
Intermittent dermal exposure to hairdressers is likely to occur when applying the hair care products to the hair of customers in salons, as gloves will probably not be used for this process. Based on similar products, the quantity used per application will be approximately 14 grams. Repeated exposure may occur through use of the product on different customers. Some accidental ocular exposure may occur. Inhalation exposure is not expected. The low concentration of the notified chemical in the hair care products (< 1%) will reduce the exposure of hairdressers.
5.4. Release
Release of Chemical at SiteThe notified chemical will not be manufactured in Australia. Local operations will include transport and storage, formulation, filling and packaging.
Release during transport
Release to the environment may occur in the unlikely event of an accident during transport or an accidental spill. The notified chemical will be transported to Australia by ship in 75 kg heat-sealed plastic bags and will be transported directly to the formulation site.
Release during formulation
During the formulation of the hair care products up to 10 kg per annum of the notified chemical will be released into the environment as a result of residual in import containers, spills and equipment cleaning. Subsequent water washes will pass to interceptor pits where the settled material will be collected and disposed of to landfill. Wastewater will be used for gardening or recycled in the plant for other processing activities. Import containers will be rinsed and disposed off to landfill. The rinsate will be collected and disposed off to a liquid waste facility by licensed contractor.
Release of Chemical from Use
Since the notified chemical will be used in hair care products, majority of the import volume is expected to be released to sewer. However, the notifier has indicated that 90% of the formulated products will be exported. Therefore, at the maximum rate of import rate ~100 kg per annum of the notified chemical is expected to be disposed of to sewers Australia wide. It is expected that up to 5 kg per annum of the notified polymer will be disposed of to landfill in empty product containers.
5.5. Disposal
The plastic bags containing residual notified chemical will be disposed of to landfill. The plastic bottles in which the hair product will be sold to consumers and the residues they contain will be disposed of in domestic landfill or recycled.The majority of the notified chemical used in hair care products domestically will ultimately be disposed of to sewer. Spilt material will be contained by absorbent, placed into containers and disposed in landfill.
5.6. Public exposure
The notified chemical will be used in the manufacture of wash-off hair care products. Public exposure will be widespread and will result through salon use of hair care products containing < 1% of notified chemical. It is expected that approximately 14 grams will be used per application and that application may occur up to once weekly. While deliberate dermal contact will occur and accidental eye contact may also occur, inhalation exposure is not expected.Public exposure during transport and storage is unlikely unless the packaging is breached.
6. PHYSICAL AND CHEMICAL PROPERTIES
Physico-chemical properties are based on Crodazosoft DBQ, containing 50% of the notified chemical.
Appearance at 20oC and 101.3 kPa / Light yellow waxy solid with mild fatty amine odour.Melting Point / 60-70 oC
Method / Not provided
Boiling Point / Not determined.
Density / Not determined
Vapour Pressure / Not determined.
Remarks / Given the ionic nature (quaternary ammonium salt) of the notified substance and its high molecular weight it is anticipated that it will have a low vapour pressure.
Water Solubility / Not determined.
Remarks / It is not possible to measure the water solubility. The notified chemical contains aliphatic hydrocarbon chains coupled to a polar end group. This constitution indicates that the material will have surfactant properties and will form micelles in solution.
Hydrolysis as a Function of pH / Not determined
Remarks / The notified chemical contains an amide group, which may undergo hydrolysis at extreme temperatures and pH conditions.
Partition Coefficient (n-octanol/water) / Not Determined
Remarks / The notified polymer has surface active properties. Thus, a reliable partition coefficient cannot be obtained. The notified chemical would be expected to partition to surfaces.
Adsorption/Desorption / Not Determined
Remarks / Based on the anticipated surface activity the substance would be expected to strongly adsorb to sediments. Quaternary ammonium compounds are known to react with dissolved organic carbon in water to form part of the sediments, and become completely inactivated on contact with soils (Nabholz JV, Miller P, Zeeman M, 1993). They have also been shown to adsorb on a wide variety of materials (Boethling RS, Lynch DG, 1992).
Dissociation Constant / Not determined.
Remarks / Contains quaternary ammonium groups that will be fully dissociated in an aqueous environment. The pH of Crodazosoft DBQ ranges from 6-8.
Particle Size / Not determined.
Remarks / The notified chemical is in a form of waxy solid flakes with diameter of 6-10mm.
Flash Point / Not determined.
Remarks / Flash point is not applicable as the notified chemical is in solid form. No solid flammability testing was conducted.
Flammability Limits / Not applicable
Remarks / The notified chemical is in solid form.
Autoignition Temperature / Not determined.
Remarks / Not expected to self-ignite.
Explosive Properties
Remarks / Not expected to be explosive
Reactivity
Remarks / Under normal conditions the notified chemical is stable. The notified chemical is incompatible with strong oxidising agents. Hazardous polymerization of the notified chemical will not occur. Hazardous decomposition products of the notified chemical are: oxides of carbon, nitrogen and sulphur.
7. TOXICOLOGICAL INVESTIGATIONS
Toxicological data provided for Crodazosoft DBQ containing approximately 50% of the notified chemical are summarised in the table below.