File No: NA/661

 June 

1999

 NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION

 AND ASSESSMENT SCHEME

 FULL PUBLIC REPORT

 LumiNova

This Assessment has been compiled in accordance with the provisions of 

the Industrial

Chemicals (Notification and Assessment) Act 1989 (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 

National

Occupational Health and Safety Commission which also conducts the 

occupational health &

safety assessment. The assessment of environmental hazard is conducted 

by the Department

of the Environment and the assessment of public health is conducted by 

the Department of

Health and Aged Care.

For the purposes of subsection 78(1) of the Act, copies of this full 

public report may be

inspected by the public at the Library, National Occupational Health 

and Safety Commission,

92-94 Parramatta Road, Camperdown NSW 2050, between the following 

hours:

 Monday - Wednesday 8.30 am - 5.00 pm

 Thursday 8.30 am - 8.00 pm

 Friday 8.30 am - 5.00 pm

Copies of this full public report may also be requested, free of 

charge, by contacting the

Administration Coordinator on the fax number below.

For enquiries please contact the Administration Coordinator at:

Street Address: 92 Parramatta Rd Camperdown, NSW 2050, AUSTRALIA

Postal Address: GPO Box 58, Sydney 2001, AUSTRALIA

Telephone: (61) (02) 9577-9514 FAX (61) (02) 9577-9465

Director
Chemicals Notification and Assessment

 

NA/661

 FULL PUBLIC REPORT

 LumiNova

1. APPLICANT

Way Out Evacuation System Pty Ltd of 103 Were Street BRIGHTON VICTORIA 

3186 has

submitted a standard notification statement in support of their 

application for an assessment

certificate for LumiNova.

The notifier reports that the chemical has been notified and used in 

plastics and paints in

European Union member countries, Switzerland, Japan and the USA.

Claims were made and accepted for the identity of the notified chemical 

to be exempt from

publication in the Full Public Report and the Summary Report. The data 

items were:

chemical name; CAS number; molecular and structural formulae; molecular 

weight; purity,

exact import volume and sites at which the notified chemical will be 

used.

2. IDENTITY OF THE CHEMICAL

The notified chemical is a mixed aluminate of metals of high atomic 

weight.

Trade Names: LumiNova

 LumiNova G-300

LumiNova G-500

LumiNova G-1000

Method of Detection the identity of the notified 

chemical was confirmed

and Determination: from X-ray diffraction data 

submitted by the notifier

3. PHYSICAL AND CHEMICAL PROPERTIES

Appearance at 20°C

and 101.3 kPa: light yellow powder
Melting Point: thermally stable without melting up to 1 

000°C

 3630.3 kg/m3

Density:

Vapour Pressure: not measured as expected to be very low

Water Solubility: 300 mg/L at 20°C

Partition Co-efficient

(n-octanol/water): log Pow < 0 at 20°C

Hydrolysis as a Function

of pH: test not conducted, see comments below

Adsorption/Desorption: log Koc < 0.29 estimated, see comments 

below

Dissociation Constant: test not conducted, see comments below

Surface Tension: 69.9 mN/m for 90% saturation solution

Flash Point: not applicable as notified chemical is a 

solid

Flammability Limits: not applicable (as notified chemical is a 

solid and

 thermally stable up to 1 000°C)

Autoignition Temperature: not applicable (as notified chemical is a 

solid and

 thermally stable up to 1 000°C)

Explosive Properties: not explosive

Reactivity/Stability: not reactive

 range 0.881 221.7 μm,

Particle Size Distribution:

 < 2.002 μm

 3.51% (by volume)

 > 203.3 μm

 0.49% (by volume)

 2.002 203.3 

μm,

 96% (by volume)

 calculated mass median aerodynamic 

diameter = 40 μm

 calculated percentage less than 10 μm 

aerodynamic

 diameter is 9.5%

 Comments on Physico-Chemical Properties
Tests were performed according to European Commission/OECD test 

guidelines (European

Commission 1992), (OECD 1995-1996) at facilities complying with OECD 

Principles of

Good Laboratory Practice. Test reports were provided (Flack,1995).

The notified chemical is an inorganic solid with a high melting point, 

and is expected to have

a low vapour pressure.

The water solubility of the notified chemical was determined by 

stirring excess amounts of

the test substance with water at 30oC for 1, 2 and 3 days in separate 

vessels. Each test was

performed in duplicate. After the allotted time for dissolution, the 

mixtures were allowed to

equilibrate at 20 oC, and the aqueous phase was filtered through 0.2 μm 

membrane filters and

then analysed for total dissolved material by gravimetric analysis. 

Dissolved constituent

elements in the samples were also determined using atomic absorption 

spectroscopy and

flame emission spectroscopy.

The results were equivocal and could not be used to accurately quantify 

the true

"stoichiometric" water solubility of the pigment. They indicate that 

the water soluble

material is more likely to be leached metal salt from the matrix rather 

than true dissolution of

the aluminate.

It is to be noted that the anomalous solubility behaviour was also 

observed in the metal

analyses performed as part of the ecotoxicity tests. The results were 

very variable, with no

consistent pattern between nominal and measured concentrations.

Hydrolytic degradation of the notified chemical was not investigated 

since it is irrelevant for

a solid inorganic compound of this nature, and would in any case be 

encompassed by data

obtained during the water solubility study. However, the notifier 

indicated that the chemical

is sensitive to moisture, and is degraded ("blackens") with exposure to 

water. Presumably

this degradation is due to decomposition of the aluminate matrix, which 

possibly accounts for

the anomalous and variable metal analysis results noted above.

An attempt to determine the n-octanol/water partition coefficient was 

made using the shake

flask method, where an excess of the material (2.02 g) was stirred in a 

flask for several hours

(overnight) with 1 L of n-octanol-saturated water at 20oC. This test 

prepared a saturated
solution of the water soluble components of the material (see above), 

of which 40 mL was

then shaken in a flask with 50 mL of water-saturated n-octanol for 15 

minutes. This

procedure was performed in duplicate, and the two phases were then 

separated by

centrifugation and analysed for dissolved material by gravimetric 

analysis. This procedure

was able to provide data only for the aqueous phase and indicated water 

soluble fractions

between 1.4 and 1.7 g/L, which are significantly higher than the 

results from the dedicated

water solubility study discussed above. Since no suitable analytical 

technique was available

to determine the concentration of the material in the n-octanol, and it 

was apparent that the

majority of the material partitioned into the aqueous phase, the value 

of log Pow was taken as

less than zero. Given the obvious variability in the water soluble 

fractions, and the

predominantly ionic nature of the test substance, this estimate for log 

Pow is accepted.

The value of log K oc was estimated from log P ow using the Kenaga and 

Goring correlation log

Koc = 0.55 log Pow + 1.377 (cited in notifiers submission, although the 

detailed reference was

not provided). In any case the ionic nature of the notified chemical 

means that estimates of

Koc are irrelevant.

Taking log Pow < 0 provides the estimate of log Koc < 1.38, indicating 

that the material has

little affinity for the organic component of soils, and that the 

dissolved ions would be very

mobile in soil.

The notifier provided a test report on surface tension of water 

solutions of the material. The

surface tension of a saturated water extract was diluted 10:9, 

producing a nominally 90%

saturated solution. Comparison of the measured surface tension of 69.2 

mN/m with that for

distilled water (71.5 mN/m) shows that the material is not surface 

active. This result is in

accord with the exclusively inorganic ionic nature of the chemical.

4. PURITY OF THE CHEMICAL

Degree of Purity: Very high

Impurities: strontium borate < 1%

 CAS# 12007-66-8

 toxic properties unknown
Additives/Adjuvants: none

5. USE, VOLUME AND FORMULATION

The notified chemical will not be manufactured in Australia, but will 

be imported at less than

200 tonnes per annum. The notified chemical will arrive in 40 L or 30 

kg steel drums lined

with air-tight, water and humidity resistant reinforced plastic liners.

The notified chemical is presented in powder form for use as a 

phosphorescent pigment in

specialised screen printing and textile inks and as a masterbatch 

(pellets containing the

notified chemical) for use in a variety of plastic (polymer) resins, 

including polycarbonate,

polyethylene, urethane, polyvinyl chloride and polystyrene. The inks 

and plastics

incorporating the notified chemical will be used for preparation of 

safety signs and other

materials associated with safety or hazard situations. The notified 

chemical may also be used

for preparation of special luminous paints. It is anticipated that 60% 

of the notified chemical

will be used in production of inks (and possibly paint), with the 

remainder used in extruded

plastic products such as luminous emergency edge markers for stairs.

6. OCCUPATIONAL EXPOSURE

Number and Category of Worker

The following categories and number of workers may be exposed to the 

notified chemical

during use.

Import and Distribution

Category of workers Number 

Hours/Day Days/Year

Handling and storage 3 2 

100

Paint/Ink and Plastic Resin Processing

Category of workers Number 

Hours/Day Days/Year

handling 5 

- -

 1 1 

200

. opening of package

. blending with 2 

2 200
 paint/plastic resin

 material

. painting/moulding 2 

7 200

storage 1 

Very low -

Workplace Exposure

In the absence of measured exposure data, the notifier has provided 

predicted workplace

dermal and inhalation exposure using the EASE (Estimation and 

Assessment of Substance

Exposure) model 1 for formulation of plastic products, formulation and 

end use of paints and

inks containing the notified chemical.

The exposure estimates derived from the model assume an open system, 

and the absence of

engineering controls and personal protective equipment. The dermal and 

inhalation exposure

assessment does not include any form of uptake (such as absorption 

through the skin in the

case of dermal exposure).

Formulation - Plastic Products

The notified chemical is a component (30%) of polymer masterbatch 

pellets. The

masterbatch pellets are removed from the original import package, 

weighed and transferred

into a blending mixer. The masterbatch is diluted to 27% to 28% 

notified chemical by the

addition of resin. Within an enclosed system this resin is extruded and 

moulded into finished

plastic products. The notifier states that up to 2% of notified 

chemical may be lost during the

moulding of pelletised resins into finished products and will be 

recovered by vacuuming.

Exposure to the notified chemical may occur during handling of the 

masterbatch pellets,

weighing and transferance to the mixer. Once extruded the chemical is 

bound within the

polymer matrix.

1

 The EASE model consists of criteria which categorise the types of 

exposure possible based upon physical properties of

substances during processing, the use pattern and pattern of control.

The EASE estimate for dermal exposure (hands and forearms, 

approximately 2 000 cm2) is:

Use pattern: inclusion into matrix (chemical is 

physically incorporated into
 resin from which release into the 

environment is substantially

 curtailed).

Pattern of control: direct handling (assumes worker handles 

the chemical in the

 absence of control measures and 

protective gear).

Dermal Contact Level: intermittent (assumes 2 to 10 events per 

day involving exposure

 as part of a process).

The model predicts that, for workers with no protective gear, dermal

exposure to the

substance will be between 0.1 and 1.0 mg/cm2/day.

Formulation - Paint/Ink

Exact details of the blending and bottling process were not provided by 

the notifier.

The notified chemical (in powder form) is removed from its original 

packaging, weighed and

transferred to a blending vessel and mixed with other paint or ink 

ingredients and then bottled

for subsequent distribution to end-users. Depending on the end use of 

the paint or ink, the

notified chemical in the blend will vary from 28 to 50%.

Dermal exposure to the notified chemical may occur during handling of 

the dry powder,

weighing and transferance to the mixer. Dermal exposure to the liquid 

paint or ink may

occur during the filling process. Inhalation exposure may occur during 

handling of the dry

powder.

The EASE estimate for dermal exposure (hands and forearms, 

approximately 2 000 cm2) is:

Use pattern: inclusion into matrix (chemical is 

physically incorporated into

 paint/ink matrix from which release into 

the environment is

 substantially curtailed).

Pattern of control: direct handling (assumes worker handles 

the chemical in the

 absence of control measures and 

protective gear).

Dermal Contact Level: intermittent (assumes 2 to 10 events per 

day involving exposure

 as part of a process).

The model predicts that, for workers with no protective gear, dermal 

exposure to the

substance will be between 0.1 and 1.0 mg/cm2/day.

The EASE estimate for inhalation exposure (to the dry powder) is:
Use pattern dry manipulation (includes any manipulation of 

the dry material).

Pattern of control local exhaust ventilation (LEV) absent (effective 

LEV removes the

 contaminant at point of origin or generation and 

therefore prevents

 contaminant from entering the air of the workroom 

where it might be

 subsequently inhaled).

The model predicts an inhalation exposure of 5 50 mg/m3.

End Use - Paints and Inks

Details of paint and ink application techniques were not provided by 

the notifier, although it

would be expected that manual application techniques and/or manual 

handling of painted

articles predominates. The prepared paints and inks may contain 28 to 

50% of the notified

chemical. Dermal exposure may occur during use of the liquid paint or 

ink.

The EASE estimate for dermal exposure (hands and forearms, 

approximately 2 000 cm2) is:

Use pattern: inclusion into matrix (chemical is 

physically incorporated into

 resin from which release into the 

environment is substantially

 curtailed).

Pattern of control: direct handling (assumes worker handles 

the chemical in the

 absence of control measures and 

protective gear).

Dermal Contact Level: intermittent (assumes 2 to 10 events per 

day involving exposure

 as part of a process).

The model predicts that for workers with no protective gear, dermal 

exposure to the

substance will be between 0.1 and 1.0 mg/cm2/day.

End Use - Plastic Products

The notified chemical in finished plastic product is bound within a 

plastic matrix. Therefore,

the potential for dermal contact to, and absorption of, the notified 

chemical is negligible.

Waste Collection

It is anticipated that the plastic liners of empty drums will retain 

less than 0.01% of their

original content. The drums are not washed out and are disposed of by 

licensed industrial

waste collection contractors. Dust and dermal exposure to these workers 

is expected to be

negligible as long as they do not directly handle the plastic liners.
Waterside, Transport and Storage

The total import volume will be transported by road in enclosed trucks 

to a storage facility.

Waterside, transport and warehouse workers, should not be exposed to 

the notified chemical

during storage and distribution, except in the event of a spill.

Prevention of Worker Exposure

The notifier states that the notified chemical will be blended into 

paints and inks in specific

mixing areas under local exhaust ventilation to capture airborne 

particles.

Sites where the notified chemical is used will have a 

precipitation/filtration pool or factory

water unit to trap any waste material present in aqueous waste water 

streams. Airborne and

floor dusts are collected by conventional methods used for the control 

of waste pigments,

additives and other chemical substances in the workplace. Due to the 

high specific gravity of

the notified chemical, any material that enters the air during the 

blending process will not

enter the factory ventilation systems but will be trapped by filters.

Workers are required to wear goggles, rubber gloves, gas and dust 

filter masks and overalls

during formulation of plastic products and paints and inks. Industrial 

painters and printers

are also likely to wear personal protective equipment, for example, 

overalls.

Worker Education and Training

The notifier states that the notified chemical will only be used by 

trained employees.

Workers will receive training (2 hour course bi-annually) on handling 

precautions using a

manual and education (2 hour course bi-annually) on chemical 

properties, prevention of

hazards against health, environmental risk and prevention and process 

precautions. Material

Safety Data Sheets (MSDS) are available to all staff and users at all 

times

7. PUBLIC EXPOSURE

The notified chemical is not manufactured locally but imported in 

containers as described in

Section 5. Transport of the notified chemical is by road. In the event 

of an accidental spill,

containment of the notified chemical is by the methods prescribed in 

the MSDS. Subsequent
disposal of spilt material will be to landfill in accordance with state 

or territory regulations.

The notified chemical will be supplied to specialist paint users and 

industrial blenders only.

The notified chemical will only be handled by trained employees during 

mixing and painting

processes and public exposure to the powder is expected to be 

negligible.

There should be negligible exposure of the notified chemical to 

customers using the final

articles due to the nature of the finished products. When used in 

plastic resin, the notified

chemical is contained within the plastic matrix. Exposure from painted 

surfaces (for

example, road and safety signs) will also be very low as the surface of 

the sign will be

laminated or otherwise protected for weather proofing purposes, thus 

minimising the

potential for environmental exposure. In addition, painted surfaces 

will generally be

inaccessible to the public.

During the lifetime of products containing the notified chemical it is 

estimated that less than

1% of the substance initially present in plastic resins will leach. 

Losses due to leaching from

paints are estimated to be less than 10%.

8. ENVIRONMENTAL EXPOSURE

 Release

The notifier indicated that some release of the new pigment was 

possible during manufacture

of plastic articles, screen printing inks and paints. During 

manufacture of plastic articles (one

batch per day), and assuming that a typical batch of 1 000 kg of resin 

may contain 28% of

LumiNova, and that 0.2% of the batch may be wasted and lost to 

receiving waters, this

equates to a maximum daily release of 560 grams of pigment. Assuming 

that this release is

to a sewer system serving a population of 10 000 (ie assumed daily 

sewage flow of

2 000 000 L), and that following passage through the sewage treatment 

plant (where no

removal takes place due to the high water solubility), a further 

dilution factor of 10 takes

place, the Predicted Environmental Concentration (PEC) of the pigment 

in receiving waters is

estimated as 0.028 mg/L.

Similarly, the notifier estimates that during printing ink and/or paint 

manufacture release of
the pigment would result in a PEC of 0.0018 mg/L, while a further 

typical release during

paint application would result in an additional 0.002 mg/L. Taking 

these together, the

estimated PEC due to manufacturing and application activities is 0.032 

mg/L. However, as

pointed out in the notification statement, much of the released pigment 

would be

encapsulated within the plastic matrix, and would not be immediately 

available for dispersal

into the wider water compartment. Consequently, the true PEC would be 

much lower than

the estimated value.

The notifier indicates that empty drums of the notified chemical would 

contain less than 5

grams of residual pigment. The drums are disposed of by licensed waste 

collectors, and

would probably be placed into landfill. Fugitive pigment resulting from 

the production of

plastic masterbatches will be collected using vacuum techniques and 

would also be placed

into landfill. Similarly residues from mixing vessels and application 

equipment used in

preparing and applying the screen printing inks is expected to be 

collected by the responsible

printing personnel, and disposed of to landfill.

 Fate

At the end of their useful lives, the textile and plastic articles 

containing the new chemical

would be incinerated or placed into landfill. This mode of disposal 

would also apply to

residuals and wastes from manufacturing processes involving the 

pigment. As indicated in

the MSDS, deposition into landfill is the preferred method for 

disposal, but even after

incineration the inorganic pigment would remain with the ash and most 

likely be placed into

landfill. Consequently, when considering the overall fate of the new 

chemical in the

environment, it is sufficient to consider only the fate after having 

been placed into landfill.

The plastics and textiles articles would be slowly degraded in a 

landfill through abiotic and

biological processes, "liberating" the associated inorganic pigment. 

The pigment is a solid

crystalline material, but appears to be appreciably soluble in water 

(see discussion of physicochemical properties), and consequently could be expected to slowly 

leach from the landfill

sites. Due to the low value for Koc it is not likely to associate with 

sediments or soils, and if

released in landfill leachate or in other ways, the chemical (or more 

likely its metallic
components) is expected to remain in the water compartment. However, 

since it is an

inorganic solid with moderate to high water solubility and low log Pow, 

the notified chemical

is unlikely to bioaccumulate. The compound will not biodegrade and is 

expected to persist in

the environment, although the distribution of the elemental components 

would be very

diffuse. It is possible that the constituent elements may eventually 

become associated with

insoluble minerals in the aquatic sediments, although this would depend 

on local

environmental factors in the water compartment such as pH and ambient 

levels of sulphate,

and bicarbonate.

9. EVALUATION OF TOXICOLOGICAL DATA

Tests were performed according to OECD test guidelines (OECD 1995-1996) 

at facilities

complying with OECD Principles of Good Laboratory Practice.

9.1 Acute Toxicity

 Summary of the acute toxicity of LumiNova

 Test Species Outcome 

Reference

 acute oral toxicity rat > 2 000 mg/kg 

(McRae, 1995)

 acute dermal toxicity rat > 2 000 mg/kg 

(McRae, 1995)

 skin irritation rabbit non irritant 

(Parcell, 1995)

 eye irritation rabbit slight 

irritant (Parcell, 1995)

 skin sensitisation guinea pig non sensitising 

(Allan, 1995)

9.1.1 Oral Toxicity (McRae, 1995)

 Species/strain: rat/ Sprague Dawley (CD)

 Number/sex of animals: 5/sex per group

 Observation period: 15 days

 Method of administration: a single dose of 2 000 mg/kg (20% w/v 

solution in corn oil)

 administered by gavage

 Test method: OECD TG 401 Limit Test

 Clinical observations: pilo-erection was observed in all 

animals through to Day 2
 Mortality: none

 Morphological findings: none

 LD50: > 2 000 mg/kg

 Result: the notified chemical was of very low 

acute oral toxicity in

 rats

9.1.2 Dermal Toxicity (McRae, 1995)

 Species/strain: rat/ Sprague Dawley

 Number/sex of animals: 5/sex

 Observation period: 15 days

 Method of administration: a single dose of 2 000 mg/kg (166.67% 

w/v in corn oil)

 applied to an intact skin site and 

covered with semiocclusive dressing; after 24 hours the 

dressing and residual

test material were removed

 Clinical observations: bodyweight fluctuations in the 

occasional animal

 Test method: OECD TG 402

 Mortality: none

 Morphological findings: none

 LD50: > 2 000 mg/kg

 Result: the notified chemical was of very low 

dermal toxicity in rats

9.1.3 Inhalation Toxicity

An acute inhalation toxicity test has not been conducted for the 

notified chemical and claims

were made and accepted for variation of schedule requirements for this 

toxicological end

point. To support their claim the notifier states that the median 

particle size of the notified

chemical is 40 μm in diameter, with less than 10% with a diameter of 10 

μm. This coupled

with the high specific gravity and negligible vapour pressure of the 

substance, limits exposure

via the inhalation route. The notifier also states that acute dermal 

and oral studies indicate

the notified chemical is unlikely to be harmful.

9.1.4 Skin Irritation (Parcell, 1995)
 Species/strain: rabbit/New Zealand White

 Number/sex of animals: 3 females

 Observation period: 4 days

 Method of administration: 0.5 g of the test substance was 

applied to intact skin site; the

 site was covered with semi occlusive 

dressing; after 4 hours

the dressing and residual test 

material were removed

 Test method: OECD TG 404

 Comment: no dermal reactions were observed 

one, 24, 48 or 72 hours

 after exposure

 Result: the notified chemical was not 

irritating to the skin of rabbits

9.1.5 Eye Irritation (Parcell, 1995)

 Species/strain: rabbit/New Zealand White

 Number/sex of animals: 2 males; 1 female (pilot animal)

 Observation period: 7 days

 Method of administration: 0.1 mL (100 mg) of the test 

substance was instilled in the

 conjunctival sac of one eye of 

each rabbit whilst the

contralateral eye of each rabbit 

served as the control

 Test method: OECD TG 405

 Draize scores of nonirrigated eyes:

 Time after 

instillation

 Animal 1 hour 1 day 2 days 3 

days 4 days 7 days

 Cornea o a o a o a o 

a o a o a

 1

 1F D 0 0 0 0 0 0 

0 0 0 0 0

 2 D 0 0 0 0 0 0 

0 0 0 0 0

 3 D 0 0 0 0 0 0 

0 0 0 0 0

 Iris
 1F 0 0 0 

0 0 0

 2 0 0 0 

0 0 0

 3 0 0 0 

0 0 0

 Conjunctiva r c r c r c r 

c r c r c

 1F 2 1 1 0 0 0 0 

0 0 0 0 0

 2 1 1 1 0 0 0 0 

0 0 0 0 0

 3 1 1 1 0 0 0 0 

0 0 0 0 0

1

see Attachment 1 for Draize scales

o = opacity a = area r = redness c = chemosis. F-female rabbit. D 

dulling.

 Comment: all animals exhibited dulling of the 

cornea one hour post

 exposure and transient well-defined 

conjunctival irritation;

 all eyes were normal at the end of day 

2

 Result: the notified chemical was a slight 

irritant to the eyes of

 rabbits

9.1.6 Skin Sensitisation (Allan, 1995)

 Species/strain: guinea pig/Dunkin Hartley White

 Number of animals: 10 males (test group), 5 males (control 

group)

 Induction procedure: test animals:

 Day 1 - three pairs of intradermal 

injections (0.1 mL) into

 the dorsal skin of the scapular region:

- Freund's complete adjuvant (FCA) 

1:1 in water for

 irrigation

 - the test substance, diluted to 

7.5% w/v in Alembicol D

 - the test substance at 7.5% w/v in 

a 50:50 mixture of

 FCA and Alembicol D.

 Day 6 - the same interscapular area was 

pre-treated with 0.2

 mL of 10% w/w sodium lauryl sulphate in 

petrolatum
 Day 7 - filter paper saturated with 0.4 

mL the test substance,

70% w/v in Alembicol D was applied to 

the treated area and

held under occlusive dressing for 48 

hours

 during the induction phase the control 

animals were treated

similarly to the test animals omitting 

the notified chemical

from the intradermal injections and 

topical applications

 Challenge procedure: test and control animals

 two weeks after topical induction, the 

posterior left flank of

each animal was treated with test 

substance, 70% w/v in

Alembicol D under occlusive dressing 

for 24 hours; the

anterior left flank was treated with 

the test substance, 35%

w/v in Alembicol D

 Challenge outcome: none of the animals exhibited evidence 

of skin sensitisation

 Test method: Magnusson and Kligman Maximisation Test 

OECD TG 406

 Result: the notified chemical was not sensitising 

to the skin of

 guinea pigs

9.2 28-Day Repeated Dose Oral Toxicity (Yamasaki, 1995)

 Species/strain: rat/Crj:CD(SD)

 Number/sex of animals: 6/sex/group

 Method of administration: gavage; vehicle was olive oil

 Dose/Study duration: test substance administered daily 

for a total of

 28 consecutive days:

 0 mg/kg/day (control)

 0 mg/kg/day (control 

recovery)

 10 mg/kg/day (low dose)

40 mg/kg/day (intermediate 

dose I)

 200 mg/kg/day (intermediate 

dose II)

 1 000 mg/kg/day (high dose)
 1 000 mg/kg/day (high dose 

recovery)

 treatment groups were sacrificed at the 

end of the 28 day

 treatment period; the recovery animals 

were sacrificed after

 a 2 week recovery period

 Mortality: one male from the 200 mg/kg/day dose 

group on day 13;

 stated by authors to be due to error in 

administration

 Clinical observations: salivation after dosing was noted in 

treated animals, 13

 animals receiving 1 000 mg/kg/day, 5 

animals receiving 200

 mg/kg/day, 4 animals receiving 40 

mg/kg/day, 2 animals

 receiving 10 mg/kg/day and one animal in 

the vehicle

 control group

 Haematology: treatment phase:

 no abnormalities were detected at the end 

of the treatment

 phase:

decreased prothrombin times were recorded 

in high dose

 males; decreased segmented neutrophils 

and increased

 lymphocyte counts were recorded in high 

dose females a the

 end of the recovery phase;

Clinical chemistry: treatment phase:

 no abnormalities were detected at the end of 

treatment;

 recovery phase:

at the end of the recovery period increased 

albumin,

 albumin/globulin ratio and total bilirubin 

and decreased

 creatinine levels were recorded in high dose 

males;

 increased blood urea nitrogen was detected 

in high dose

 females

Urinalysis: no abnormalities were detected

Macroscopic examination: treatment phase:

 a blackish region of the mucosa of the 

glandular stomach
 was noted in a 200 mg dose male and a 

control group male;

 blackish mucosa of the glandular stomach was 

observed in

 one high dose female and whiteish patches in 

the liver in

 one low dose female;

recovery phase:

no significant treatment related findings

Histopathology: treatment phase:

 necrosis of the glandular stomach was noted 

in one

 intermediate dose II male; necrosis of 

hepatocytes were

 noted in one low dose female; all other 

findings were no

 different to those found in control animals;

 recovery phase:

no abnormalities detected in treated animals

Organ weights: treatment phase:

 a significant increase in absolute adrenal 

gland weight in

 high dose males;

 recovery phase:

a significant increase in relative spleen 

weight in high dose

 females

Test method: OECD TG 407

Comment: the notified chemical did not exhibit any 

significant organ

 toxicity in rats; changes in haematology and 

clinical

 chemistry parameters observed at the end of 

the recovery

 period in high dose animals were considered 

to be

 accidental as they were not observed at the 

end of the

 treatment period; increased spleen weights 

in high dose

 females at the end of recovery were 

considered accidental

 as there was no change in organ weight and

 histopathological examinations at the end 

of the treatment

 period;

increased absolute adrenal weights in high 

dose males were

 suspected as being related to treatment, 

however, there were
 no histopathological findings associated 

with the weight

 increase,

the cause of death of the one animal during 

the treatment

 phase was attributed to dose administration 

error

 Result: the NOEL was established at 200 mg/kg/day, 

based upon

 increased absolute adrenal gland weights in 

males of the

 1 000 mg/kg/day dose group

9.3 Genotoxicity

9.3.1 Salmonella typhimurium and Escherichia coli Reverse Mutation 

Assay (Jones,

1995)

 Strains: Salmonella typhimurium TA 1537, TA 1535, TA 

100 and

 TA 98 and Escherichia coli WP2 (uvrA)

 Metabolic activation liver fraction (S9 mix) from rats 

pretreated with Aroclor

 system: 1254

 312.5, 625, 1 250, 2 500 and 5 000 

μg/plate;

 Concentration range:

 each concentration was tested in 

triplicate, with or without

 metabolic activation, in two independent 

experiments;

 appropriate strain specific positive 

control reference

 substances were used

 Test method: OECD TG 472

 Comment: there were no significant increases in 

revertant colony

 numbers at any dose level, with or without 

metabolic

 activation;

concurrent positive controls used in the 

test induced marked

 increases in the frequency of revertant 

colonies and the

 activity of the S9 fraction was found to be 

satisfactory

 Result: the notified chemical is not considered to 

be mutagenic in

 the bacterial strains tested
9.3.2 Chromosomal Aberration Assay in Chinese Hamster Lung 

Fibroblasts (Ogura,

 1995)

 Cells: Chinese Hamster Lung Fibroblasts

 Metabolic activation liver fraction (S9 mix) from rats 

pretreated with

 system: phenobarbital and 5,6-benzofulavone

 Dosing schedule: two independent experiments as follows

 without metabolic activation:

1 250, 2 500 and 5 000 μg/mL;

treatment time = 24 hours or 48 hours;

positive control: 0.05μg/mL mitomycin C;

 with metabolic activation:

1 250, 2 500 and 5 000 μg/mL,

treatment time: 6 hours,

recovery time: 18 or 42 hours

positive control: 10μg/mL 

cyclophosphamide;

 Test method: OECD TG 473

 Comment: precipitation was observed at all test 

doses;

 the mitotic index for each maximum 

concentration was less

 than 50% in the groups treated, in the 

absence of metabolic

 activation and in the 42 hour recovery 

group, in the

 presence of metabolic activation and 

greater than 50% in

 the 18 hour recovery group in the presence 

of metabolic

 activation;

the test substance did not cause any 

significant increases in

 the proportion of aberrant cells, at any 

dose level, or

 treatment time in the presence or absence 

of metabolic

 activation;

positive controls used in the test caused 

marked increases in

 the proportion of aberrant cells and the 

activity of the S9

 fraction was found to be satisfactory

 Result: the notified chemical was not considered 

to be clastogenic

 under the conditions of this chromosomal 

aberration test
9.4 Overall Assessment of Toxicological Data

The notified chemical has very low acute oral toxicity (LD50 > 2 000 

mg/kg) and low dermal

toxicity (LD 50 > 2 000 mg/kg) in rats. Acute inhalation studies have 

not been conducted for

the notified chemical and claims were made and accepted for variation 

of schedule

requirements for this toxicological end point, on the basis of the 

concentration of respirable

particles, high specific gravity and negligible vapour pressure of the 

substance. In rabbits,

the notified chemical was not a skin irritant but was slightly 

irritating to eyes. The notified

chemical was not sensitising to guinea pig skin.

In a 28 day repeat oral dose study, the notified chemical did not 

exhibit any significant organ

toxicity in rats; changes in haematology and clinical chemistry 

parameters noted at the end of

the recovery period were considered co-incidental as they were observed 

only at the end of

the treatment period. Increased spleen weights in high dose females at 

the end of recovery

were also considered accidental as there was no changes in observed 

organ weight or

histopathology at the end of the treatment period. Increased absolute 

adrenal weights in high

dose males were suspected as being related to treatment, however, there 

were no

histopathological findings associated with the weight increase. The 

NOEL was established at

200 mg/kg/day, based upon increased absolute adrenal gland weights in 

males of the

1 000 mg/kg/day dose group.

The notified chemical revealed no mutagenic activity in a bacterial 

test system or in vitro

chromosome aberration test.

Based on the data submitted the notified chemical would not be a 

hazardous substance under

the NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC 

1999).

10. ASSESSMENT OF ENVIRONMENTAL EFFECTS

The notifier provided the following ecotoxicity data in support of 

their application. The

ecotoxicity tests were performed in accordance with OECD Test 

Guidelines (OECD 1995-

1996).

Test Species Results (Nominal) 

References

 mg/L
Acute Toxicity Oncorhynchus LC50(96 h) = 6.8 

(Bell, 1995)

(OECD TG 203) mykiss NOEC (96 h) = 1.8

 (Rainbow trout)

Acute Immobilisation Daphnia magna EC50(48 h) = 13 

(Bell, 1995)

(OECD TG 202 Part 1) NOEC(48 h) = 4.6

Inhibition of Algal Selanastrum EbC50(72 h) =19 

(Bell, 1995)

Growth capricornatum NOEC(72 h) = 4.6

(OECD TG 201) ErC50(0-72 h) = 29

Inhibition of Bacterial Activated Sludge EC50 (3 h) > 100 

(Kelly, 1996)

Respiration Bacteria

(OECD TG 209)

The tests on rainbow trout were performed using solutions of the test 

material made up in

dechlorinated water. The tests were conducted over a 96 hour period at 

a controlled

temperature of 16±1 oC with supplementary aeration, and the test media 

was replaced daily in

a batchwise manner. Five solutions of the chemical with nominal 

concentrations of 4.6, 10,

22, 46 and 100 mg/L were tested, together with one control. The 

measured results were

extremely variable, with measured concentrations of the notified 

chemical between 10 and

84% of the nominal concentrations. There appeared to be no pattern to 

the variation in

determined concentrations, which is similar to the anomalous findings 

in the water solubility

study. However, it was noted during the analytical work that the 

apparent solubility of the

notified chemical appeared dependent on the amount of starting 

material, and this is possibly

connected with the hydrolytic degradation mentioned earlier in 

connection with the water

solubility and hydrolytic degradation (see section 3 Physico - Chemical 

Properties).

Seven fish were tested at each concentration, and during these tests 

the pH of the test

solutions was always between 7.9 and 8.1, dissolved oxygen levels were 

always between 8.3

and 8.9 mg/L and mean water hardness was 137 mg/L as CaCO3. The test 

results indicate

that the notified chemical is moderately toxic to rainbow trout with a 

nominal 96 hour LC50

of 6.8 mg/L determined using the method of Thompson and Weil (Thompson 

et al 1952).

The only sublethal effect noted in the test report was loss of 

equilibrium. The responses
listed in the raw data were such that Probit analysis was not possible, 

but it is agreed that the

96-hour LC50 would lie between 4.6 and 10.0 mg/L.

The acute immobilisation tests on daphnia were performed using 

solutions of the test material

made up in dechlorinated water. A stock solution of the test material 

was serially diluted and

used in a static non-renewal system over a 48-hour period at a 

controlled temperature of

22oC. Five solutions of the chemical with nominal concentrations of 

4.6, 10, 22, 46 and 100

mg/L were tested, together with one control.

Ten daphnia were tested at each concentration, with each test performed 

in duplicate. During

these tests the pH of the test solutions was always between 7.5 and 

8.4, while dissolved

oxygen levels (measured for the control only) were always between 7.9 

and 8.4 mg/L. The

criterion for deciding on immobilisation was if the animals were unable 

to swim after gentle

agitation of the test vessel. The results indicate that the notified 

chemical is slightly toxic to

Daphnia magna with a nominal 48-hour EC50 of 13 mg/L determined using 

the method of

Thompson and Weil. The responses listed in the raw data were such that 

Probit analysis was

not possible, but it is agreed that the 96-hour LC50 would lie between 

10.0 and 22.0 mg/L.

Again, although attempts were made to measure the concentration of the 

notified chemical in

the test water, this was not possible because of the large variability 

in the results.

A chronic study on daphnia reproduction was not performed.

A test on the inhibition of algal growth was conducted on Selanastrum 

capricornutum over a

72 hour incubation period at 24oC at pH 8.0-8.1 with nominal 

concentrations of the test

substance in dechlorinated water of 4.6, 10, 22, 46 and 100 mg/L, 

together with a control

containing no chemical. As with the other ecotoxicology tests, there 

was significant variation

between the nominal and measured concentrations of the test substance. 

The nominal result

of EC50 = 19 mg/L indicates that the notified chemical is slightly 

toxic to this species of green

algae.

The notified chemical was at most slightly toxic to sewage sludge 

bacteria, and in a parallel

reference test using 3,5-dichlorophenol, the 3-hour EC50 was determined 

as 10.0 mg/L.
These ecotoxicity results indicate that the new pigment is slightly to 

moderately toxic to the

aquatic test species. It is likely that the toxicity is associated with 

the release of aluminium as

opposed to other metals, since aluminium precipitates as an amorphous 

gel of hydrated

hydroxides in the pH region 7.4-8.5 where the tests were conducted. 

This material may

disrupt oxygen and gas transfer in aquatic organisms by coating gills 

and other organs.

11. ASSESSMENT OF ENVIRONMENTAL HAZARD

The notified chemical is appreciably water soluble, but when bound into 

polymer matrices in

plastic articles or with binders on the surface of screen printed 

signs, little release is likely

because of the low contact between water and the hydrophobic plastic 

encapsulating the

pigment. The notifier indicates that when used as a pigment in screen 

printed signs, it is

important that the pigment be protected from exposure to water by 

regular application of

clear coat protective lacquers. However, although the notifier 

estimates that only 1% of the

pigment would be lost through leaching during the service life of the 

various signs and plastic

articles containing the notified chemical, some leaching and loss of 

the pigment seems

inevitable due to factors such as irregular or incomplete maintenance 

of the signs and wear

and tear of plastic stairway markers etc. This would probably result in 

irreparable damage

(see Comments on Physico - Chemical Properties Section 3) leading to 

replacement of the

affected sign(s) or other articles.

Eventually all the painted signs and plastic articles will be degraded, 

for example, through

incineration or slow degradation and decomposition in landfill, and the 

integrity of the

polymer matrices would be breached allowing for contact of the notified 

chemical with water

and subsequent leaching of the aluminium and other metals. Ultimately 

all the notified

chemical would be released into the environment, but since the hazard 

and safety signs are

likely to be used throughout Australia, release would be widespread and 

diffuse. Since it is

anticipated that up to 100 tonnes of the pigment may be imported each 

year, this ultimately

equates to an annual release of up to 100 tonnes per year. All released 

metals will be mobile

in soils and consequently all the material will ultimately be released 

to the water

compartment.
Some release is likely during manufacture and application of screen 

printing inks and plastic

articles and paint containing the pigment. However, as noted above this 

estimated to lead to a

typical Predicted Environmental Concentration of around 0.03 mg/L, 

which is three orders of

magnitude below toxic levels. Further, much of this released pigment 

will be associated with

plastic in a solid matrix, and will not be immediately released into 

the wider environment.

The notified chemical is slightly to moderately toxic to the aquatic 

life forms against which it

has been tested, and all is likely to be released to the water 

compartment. This toxicity is

probably associated with precipitation of gelatinous aluminium 

hydroxides rather than the

other metals. However, except in the cases of release during 

manufacturing processes, the

primary release of the pigment will be associated with the slow 

degradation of plastic and

textile articles into which the pigment is incorporated. This release 

will be widespread and

very diffuse, and unlikely to lead to toxic concentrations of the 

chemical.

When used as indicated in the notification, the notified chemical is 

unlikely to present a

hazard to the environment.

12. ASSESSMENT OF PUBLIC AND OCCUPATIONAL HEALTH AND SAFETY

EFFECTS

The notifier reports that the notified chemical has been used as a 

phosphorescent pigment in

plastics and paints in European Union member countries, Switzerland, 

Japan and the USA for

five years with no reported health implications associated with its 

use.

The notified chemical had very low acute oral toxicity (LD50> 2 000 

mg/kg) and low dermal

toxicity (LD50 > 2 000 mg/kg) in rats. The notified chemical was a 

slight eye irritant but was

not a skin irritant in the rabbit, and was not sensitising to guinea 

pig skin. A 28 day oral

repeat dose study in rats revealed no evidence of systemic toxicity at 

doses of 200 mg/kg/day;

at 1 000 mg/kg/day increased absolute adrenal weights in males were 

observed but these were

not accompanied by histopathological findings. The NOEL was established 

at 200

mg/kg/day. Bacterial mutagenicity and an in vitro cytogenetic study 

were negative. Acute
inhalation studies were not conducted with the notified chemical. The 

calculated mass

median aerodynamic diameter is 40 μm and the percentage of respirable 

particles (<10 μm)

was 9.5% by volume. Therefore, potential for inhalation of the notified 

chemical in powder

form exists.

Based on the data submitted the notified chemical would not be 

classified as a hazardous

substance under NOHSC Approved Criteria for Classifying Hazardous 

Substances (NOHSC

1999).

Occupational Health an Safety

Formulation, Blending and End Use

In the absence of measured exposure data, the notifier has provided 

predicted workplace

dermal and inhalation (dust) exposure using the EASE (Estimation and 

Assessment of

Substance Exposure) model. The parameters used in the model assume an 

open system, and

the absence of engineering controls and personal protective equipment. 

NICNAS concurs

with the assumptions and the parameters selected for input into the 

EASE computer model.

During formulation of plastic products exposure to the notified 

chemical is most likely to

occur during handling of the masterbatch. The model predicts dermal 

exposure of the arms

and forearms will be between 0.1 and 1.0 mg/cm2/day, which is 

considered moderate.

Inhalation exposure will be negligible.

Assuming 10% dermal absorption, the body burden following dermal 

exposure to the

masterbatch is (calculated by the product of the skin area of both 

hands and forearms

(2 000 cm2) and the value of 0.1 to 1.0 mg/cm2/day of substance 

deposited on the skin,

divided by the average bodyweight of a worker, ie 70 kg) in the range 

of 0.29 to 2.86

mg/kg/day.

During blending of the notified chemical into paints and inks, dermal 

and inhalation exposure

is most likely to occur as a result of dry powder charging of mixing 

vessels. During

blending/bottling procedures exposure will be limited to skin contact. 

For these activities the

model predicts moderate (0.1 to 1.0 mg/cm2/day) dermal exposure and 

inhalation exposure is

predicted at 5 50 mg/m3.
Assuming that 10m3 air is inhaled per day, an average worker weight of 

70 kg and 100%

adsorption, the body burden resulting from inhalation exposure in the 

range of 5 to 10 mg/m3

would be 5 (or 10) x 10/70 = 0.71 to 1.42 mg/kg/day. A range of 5 to 10 

mg/m3 is chosen

instead of the range 5 to 50 mg/m3 predicted in the EASE model because 

the blending

process would be an intermittent procedure and actual exposures would 

be at the low end of

the predicted ranges. The use of personal protective equipment will 

further control exposure.

The upper value of 10 mg/m3 is also chosen as it represents the NOHSC 

8-hour TWA

exposure standard for aluminium oxide (measured as inspirable dust).

Assuming 10% dermal absorption, the body burden following dermal 

exposure during

blending of the powder into paints and inks is (calculated by the 

product of the skin area of

both hands and forearms (2 000 cm2) and the value of 0.1 to 1.0 

mg/cm2/day of substance

deposited on the skin, divided by the average bodyweight of a worker, 

ie 70 kg) in the range

of 0.29 to 2.86 mg/kg/day.

The body burden from combined dermal and inhalation exposure is in the 

range of

6.7 to 13.4 mg/kg/day.

During the end use of prepared paints and inks, dermal exposure is 

calculated between

0.1 and 1.0 mg/cm2/day, which is considered moderate. Inhalation 

exposure will be

negligible.

Assuming 10% dermal absorption, the body burden following dermal 

exposure to prepared

inks and paints is (calculated by the product of the skin area of both 

hands and forearms

(2 000 cm2) and the value of 0.1 to 1.0 mg/cm2/day of substance 

deposited on the skin,

divided by the average bodyweight of a worker, ie 70 kg) in the range 

of 0.29 to 2.86

mg/kg/day.

The notified chemical has low acute toxicity and therefore the risk of 

adverse effects

following acute exposure to the notified chemical is considered low. 

Slight eye irritation

immediately following exposure may occur, however, the wearing of eye 

protection should

minimise this risk.

To characterise the risk associated repeated or prolonged exposure to 

the notified chemical,
the margin of exposure (MOE) can be calculated by comparing the EASE 

exposure estimate

with the NOEL of 200 mg/kg/day.

The Table below presents exposure estimates and MOE for dermal, 

inhalation and combined

exposure.

 PROCESS EXPOSURE ESTIMATE (mg/kg/day) 

MOE

 Dermal Inhalation Dermal &

 Inhalation

Plastic Products:

. formulation & 0.29 2.86 negligible 0.29 

2.86 70 to very high

moulding,

. end use negligible negligible 

negligible very high

Paints & Inks:

. formulation 0.29 2.86 0.71 - 1.42 1 to 

4.28 47 to 200

. end use 0.29 2.86 negligible 0.29 

2.86 70 to very high

In summary, the calculated MOE predict low level of concern, in the 

absence of engineering

controls and personal protective equipment.

However, the formulation process is enclosed and the notifier states 

that local exhaust

ventilation will be positioned to capture airborne particles to control 

inhalation exposure to

the notified chemical. In addition, the notified chemical and 

formulations containing the

chemical will be handled and used by skilled, trained workers wearing 

suitable personal

protective equipment, that is, dust masks, goggles, rubber gloves and 

overalls. These control

measures are stated by the notifier to be standard practice. There is, 

therefore, little cause for

concern with respect to systemic effects following repeated exposure 

during formulation and

end use. The risk associated with the proposed use of the notified 

chemical will be low as

long as these engineering and personal protection controls are in 

place.
As indicated by the MOE and as part of good hygiene practices, dust 

levels in the workplace

should be controlled to well below the NOHSC exposure standard for 

`Aluminium oxide,

10 mg/m3 TWA (measured as inspirable fraction)'(NOHSCa 1995). Since the 

notified

chemical contains respirable particles, the ACGIH respirable 

particulate threshold limit value

(TLV) of 3 mg/m 3 can be used as guidance for the control of respirable 

dust in the workplace

(ACGIH 1998). Employers are responsible for ensuring the exposure 

standard is not

exceeded.

Biological monitoring of a constituent element of the notified chemical 

is proposed by the

notifier for workers handling the notified chemical. It is recommended 

that the authorised

medical practitioner responsible for health surveillance in the 

workplace give due

consideration to the Guidelines for Health Surveillance Introduction 

(NOHSCb 1995)

before implementation of a health surveillance program for this 

chemical.

Transport, Storage and Disposal

During the importation and transportation of the notified chemical, 

there is unlikely to be any

worker exposure, except in the event of a spill. Exposure after a spill 

would be controlled by

use of the recommended practices for spillage clean up given in the 

MSDS supplied by the

notifier. Exposure to the notified chemical from disposal of original 

import containers is

expected to be negligible unless workers handle the liners of empty 

drums which are

estimated to retain less than 0.01% of chemical.

Public Health

Based on the very low exposure of the public to the notified chemical 

and its

physicochemical and toxicological properties it is considered that the 

notified chemical will

not pose a significant hazard to public health when used in the 

proposed manner.

13. RECOMMENDATIONS

To minimise occupational exposure to LumiNova the following guidelines 

and precautions

should be observed:

 As a precautionary note in the event of a major spill either

during transport or
·

 formulation, it is recommended that MSDS and label for the 

notified chemical carry

 the safety phrase avoid breathing dust.

 Avoid generation and breathing of dust when handling the 

notified chemical in

·

 powder form;

 Provide local exhaust ventilation when handling the notified 

chemical in powder

·

 form(Standards Australia 1994);

 Dust levels in the workplace should be controlled to below the 

NOHSC exposure

·

 standard for `Aluminium oxide, 10 mg/m3 TWA (measured as 

inspirable

 fraction)'(NOHSCa 1995). Since the notified chemical contains 

respirable particles,

 the ACGIH respirable particulate threshold limit value (TLV) of 

3 mg/m3 can be used

 as guidance for the control of respirable dust in the workplace 

(ACGIH 1998).

 Employers are responsible for ensuring the exposure standard is 

not exceeded;

 The authorised medical practitioner responsible for health 

surveillance in the

·

 workplace give due consideration to the Guidelines for Health 

Surveillance 

 Introduction (NOHSCb 1995) before implementation of a health 

surveillance program

 for the notified chemical.

 Respiratory protection should conform to AS 1715 (Standards 

Australia/Standards

·

 New Zealand 1994), and AS 1716 (Standards Australia/Standards 

New Zealand

 1994);

 Safety goggles should be selected and fitted in accordance with 

AS 1336 (Standards

·

 Australia 1994) to comply with AS/NZS 1337 (Standards 

Australia/Standards New

 Zealand 1992);

 Industrial clothing should conform to the specifications 

detailed in AS 2919

·

 (Standards Australia 1987) and AS 3765.1 (Standards Australia 

1990);
 Impermeable gloves should conform to AS/NZS 2161.2 (Standards 

Australia 1998);

·

 All occupational footwear should conform to AS/NZS 

2210 (Standards

·

 Australia/Standards New Zealand 1994);

 Spillage of the notified chemical should be avoided. Spillages 

should be cleaned up

·

 promptly with absorbents which should be put into containers for 

disposal;

 Good personal hygiene should be practised to minimise the 

potential for ingestion;

·

 A copy of the MSDS should be easily accessible to employees.

·

14. MATERIAL SAFETY DATA SHEET

The MSDS for the notified chemical was provided in a format consistent 

with the National

Code of Practice for the Preparation of Material Safety Data Sheets 

(NOHSC 1994).

This MSDS was provided by the applicant as part of the notification 

statement. It is

reproduced here as a matter of public record. The accuracy of this 

information remains the

responsibility of the applicant.

15. REQUIREMENTS FOR SECONDARY NOTIFICATION

Under the Act, secondary notification of the notified chemical shall be 

required if any of the

circumstances stipulated under subsection 64(2) of the Act arise. No 

other specific

conditions are prescribed.

16. REFERENCES
ACGIH (1998). Threshold Limit Values for Chemical Substances and 

Physical Agents and

Biological Exposure Indices 1997-1998. Cincinatti, Ohio, American 

Conference of

Governmental Hygienists (ACGIH).

Allan SA (1995). LumiNova Skin Sensitisation in the Guinea Pig. 

Cambridgeshire,

Huntingdon Research Centre Ltd.

Bell G (1995). LumiNova Acute Toxicity to Daphnia magna. 

Cambridgeshire, Huntingdon

Research Centre Ltd.

Bell G (1995). LumiNova Acute Toxicity to Rainbow Trout (Oncorhyncus 

mykiss).

Cambridgeshire, Huntingdon Research Centre Ltd.

Bell G (1995). LumiNova Algal Growth Inhibition. Cambridgeshire, 

Huntingdon Research

Centre Ltd.

European Commission (1992). European Commission Directive 92/69/EC , 

Annex V, Part A

Methods for Determination of Physico-Chemical Properties. Brussels.

Flack I (1995). LumiNova PhysicoChemical Properties. Cambridgeshire, 

Huntingdon

Research Centre Ltd.

Jones E (1995). LumiNova Bacterial Mutation Assay. Cambridgeshire, 

Huntingdon Research

Centre Ltd.

Kelly C (1996). LumiNova Inhibitory Effect on the Respiration of 

Activated Sewage Sludge.

Cambridgeshire, Huntingdon Research Centre Ltd.

McRae LA (1995). LumiNova Acute Dermal Toxicity to the Rat. 

Cambridgeshire,

Huntingdon Research Centre Ltd.

McRae LA (1995). LumiNova Acute Oral Toxicity to Rats. Cambridgeshire, 

Huntingdon

Research Centre Ltd.

NOHSC (1994). National Code of Practice for the Preparation of Material 

Safety Data Sheets

[NOHSC:2011(1994)]. Canberra, Australian Government Publishing Service.

NOHSC (1999). Approved Criteria for Classifying Hazardous Substances

[NOHSC:1008(1999)]. Canberra, Australian Government Publishing Service, 

In press.

NOHSCa (1995). Adopted National Exposure Standards for Atmospheric 

Contaminants in
the Occupational Environment, [NOHSC:1003(1995)]. Exposure Standards 

for Atmospheric

Contaminants in the Occupational Environment: Guidance Note and 

National Exposure

Standards. Canberra, Australian Government Publishing Service.

NOHSCb (1995). Guidelines for Health Surveillance - Introduction [NOHSC 

7039(1995)].

Canberra, Australian Government Publishing Service.

OECD (1995-1996). OECD Guidelines for the Testing of Chemicals on CDRom. Paris,

Organisation for Economic Co-operation and Development, (OECD).

Ogura S (1995). Chromosomal Aberration Test of LumiNova Using Cultured 

Mammalian

Cells. Oita, Japan, Hita Research Laboratories, Chemical Biotesting 

Center, Chemicals

Inspection & Testing Institute.

Parcell BI (1995). LumiNova Eye Irritation to the Rabbit. 

Cambridgeshire, Huntingdon

Research Centre Ltd.

Parcell BI (1995). LumiNova Skin Irritation to the Rabbit. 

Cambridgeshire, Huntingdon

Research Centre Ltd.

Standards Australia (1987). AS 2919-1987, Australian Standard 

Industrial Clothing. Sydney,

Standards Australia.

Standards Australia (1990). AS 3765.1-1990, Australian Standard

Clothing for Protection

against Hazardous Chemicals Part 1 Protection Against General or 

Specific Chemicals.

Sydney, Standards Australia.

Standards Australia (1994). AS 1336-1994, Australian Standard Eye 

protection in the

Industrial Environment. Sydney, Standards Australia.

Standards Australia (1994). AS 1668.2, Mechanical Ventilation and Air 

Conditioning Code

Part 2 - Ventilation Requirements. Sydney, Standards Australia.

Standards Australia (1998). AS/NZS 2161.2:1998, Australian/New Zealand 

Standard

Occupational Protective Gloves Part 2: General Requirements. 

Sydney/Wellington, Standards

Australia and Standards New Zealand.

Standards Australia/Standards New Zealand (1992). AS/NZS 1337-1992, 

Australian/New

Zealand Standard Eye Protectors for Industrial Applications. 

Sydney/Wellington, Standards

Australia and Standards New Zealand.
Standards Australia/Standards New Zealand (1994). AS/NZS 1715-1994, 

Australian/New

Zealand Standard Selection, Use and Maintenance of Respiratory 

Protective Devices.

Sydney/Wellington, Standards Australia and Standards New Zealand.

Standards Australia/Standards New Zealand (1994). AS/NZS 1716-1994, 

Australian/New

Zealand Standard Respiratory Protective Devices. Sydney/Wellington, 

Standards Australia

and Standards New Zealand.

Standards Australia/Standards New Zealand (1994). AS/NZS 2210-1994, 

Australian/New

Zealand Standard Occupational Protective Footwear. Sydney/Wellington, 

Standards Australia

and Standards New Zealand.

Thompson WR Weil CS (1952). Biometrics 8: 51-54.

Yamasaki K DVM (1995). Twenty-Eight-Day Repeated Dose Oral Toxicity 

Study of

LumiNova in Rats. Oita, Japan, Hita Research Laboratories, Chemical 

Biotesting Center,

Chemicals Inspection & Testing Institute.

 Attachment 1

The Draize Scale for evaluation of skin reactions is as follows:

Erythema Formation Rating 

Oedema Formation Rating

No erythema 0 

No oedema 0

Very slight erythema (barely perceptible) 1 

Very slight oedema (barely perceptible) 1

Well-defined erythema 2 

Slight oedema (edges of area well- 2

 

defined by definite raising

Moderate to severe erythema 3 

Moderate oedema (raised approx. 1 mm) 3

Severe erythema (beet redness) 4 

Severe oedema (raised more than 1 mm 4

 

and extending beyond area of exposure)

The Draize scale for evaluation of eye reactions is as follows:

CORNEA

Opacity Rating 

Area of Cornea involved Rating

No opacity 0 none 

25% or less (not zero) 1
Diffuse area, details of iris clearly 1 slight 

25% to 50% 2

visible

Easily visible translucent areas, details 2 mild 

50% to 75% 3

of iris slightly obscure

Opalescent areas, no details of iris 3 

Greater than 75% 4

visible, size of pupil barely discernible moderate

Opaque, iris invisible 4 severe

CONJUNCTIVAE

Redness Rating Chemosis 

Rating Discharge Rating

Vessels normal 0 none No swelling 

0 none No discharge 0 none

Vessels definitely 1 Any swelling above 

1 slight Any amount different 1 slight

injected above normal slight normal 

from normal

More diffuse, deeper 2 mod. Obvious swelling with 

2 mild Discharge with 2 mod.

crimson red with partial eversion of lids 

moistening of lids and

individual vessels not 

adjacent hairs

 Swelling with lids halfeasily discernible

closed 

3 mod. Discharge with 3 severe

Diffuse beefy red 3 severe 

moistening of lids and

 Swelling with lids halfhairs and considerable

 closed to completely 

4 severe area around eye

 closed

IRIS

Values 

Rating

Normal 

0 none

Folds above normal, congestion, swelling, circumcorneal injection, iris 

reacts to light 1 slight

No reaction to light, haemorrhage, gross destruction 

2 severe