Ftalatos

4. How can humans be exposed to DIDP and DINP?

4.1 How can workers be exposed to DIDP and DINP?
4.2 How can consumers be exposed to DIDP and DINP?
4.3 What are the estimated overall exposures to DIDP and DINP?

4.1 How can workers be exposed to DIDP and DINP?

DIDP

"Exposure assessment

Occupational exposure

Occupational exposure to DIDP may occur:

• by skin contact with pure DIDP, or mixtures (formulations) or end products containing it,
  
• by inhalation (vapours and aerosol).

Oral exposure is not considered to be a significant route of exposure under normal working practices.

Few countries have defined Occupational Exposure Limits for DINP. In the UK, the HSE
(1997) indicates an occupational exposure standard (8-hour TWA) of 5 mg/m³ for DIDP
(CAS 26761-40-0). In Sweden, KEMI (1997) indicates a “level limit value” of 3 mg/m³ and a “short-term value” of 5 mg/m³ which apply to phthalates such as DIDP for which no specific- limit values have been defined.

Workers may be exposed to DIDP at different representative stages of its life cycle. The following exposure scenarios are considered:

1. manufacture of DIDP (reactor opening, drumming, pumping into tanks, cleaning, maintenance, etc.),

2. manufacture of products containing DIDP as a plasticizer or a solvent (adding, mixing, processing e.g. calendering, extruding, injection moulding, etc.)

3. use of end products containing DIDP (use of e.g. coatings, adhesives or inks).

In PVC formulations, the typical amount of DIDP is about 20 - 40% but may go up to 55%. In end products, the amount varies greatly from less than 1% to more than 50%.

Dermal exposure

In view of the very low absorption of DINP by the dermal route, a maximum dermal exposure of 5 mg/cm² is intentionally assumed for all scenarios. Actual levels of dermal exposure are much lower in most occupational circumstances.

Inhalation exposure

Inhalation occupational exposure is resumed in Table 4.1.

Table 4.1 Inhalation occupational exposure

Due to the very low vapour pressure of DIDP, exposure by inhalation is in fact to air-borne particles (aerosols)."

Source & © : ECB "2003 Risk Assessment Report (RAR 041) on
Di-"isodecyl" Phthalate (DIDP), Summary of the Report,
chapter 4: Human Health

For more information, see the full ECB Risk Assessment Report:
Chapter 4: Human Health

DINP

"Exposure assessment

Occupational exposure

Occupational exposure to DINP may occur:

• by skin contact with pure DINP, or mixtures (formulations) or end products containing it,
• by inhalation (vapours and aerosols).

Oral exposure is not considered to be a significant route of exposure under normal working practices.

Few countries have defined Occupational Exposure Limits for DINP. In the UK, the HSE
(1997) indicates an occupational exposure standard (8-hour TWA) of 5 mg/m³ for DINP 2
(CAS 28553-12-0). In Sweden, KEMI (1997) indicates a “level limit value” of 3 mg/m³ and a “short-term value” of 5 mg/m³ which apply to phthalates such as DINP for which no specific limit values have been defined.

Workers may be exposed to DINP at different representative stages of its life cycle. The following exposure scenarios are considered:

1. manufacture of DINP (reactor opening, drumming, pumping into tanks, cleaning, maintenance, etc.),

2. manufacture of products containing DINP as a plasticizer or a solvent (adding, mixing, processing e.g. calendering, extruding, injection moulding, etc.)

3. use of end products containing DINP (use of e.g. coatings, adhesives or inks).

In PVC formulations, the typical amount of DINP is about 20 - 40% but may go up to 55%. In end products, the amount varies greatly from less than 1% to more than 50%.

Dermal exposure

In view of the very low absorption of DINP by the dermal route, a maximum dermal exposure of 5 mg/cm² is intentionally assumed for all scenarios. Actual levels of dermal exposure are much lower in most occupational circumstances.

Inhalation exposure

Inhalation occupational exposure is resumed in Table 4.1.

Table 4.1 Inhalation occupational exposure

Due to the very low vapour pressure of DINP, exposure by inhalation is in fact to air-borne particles (aerosols)."

Source & © : ECB "2003 Risk Assessment Report (RAR 046) on
Di-"isononyl" Phthalate (DINP), Summary of the Report,
chapter 4: EHuman Health

For more information, see the full ECB Risk Assessment Report:
Chapter 4: Human Health

4.2 How can consumers be exposed to DIDP and DINP?

DIDP

"Consumer exposure

DIDP is a plasticizer used in several flexible PVC end products as cables and wires, sheets, film, wall- and roof covering, flooring, coatings and synthetic leather (car seats, home furniture), shoes and boots, outdoor and rainwear, car under-body coating. DIDP is also used in several non-PVC end products as paints, printing inks, rubbers, latex and adhesives. All of these products are available to consumers. However, DIDP is not available to consumers as such. Consumer exposure may also occur through food and drinking because of contamination from packaging and processing equipment containing DIDP.

DIDP had been used in toys in the past, so it may be considered as an alternative to other phthalates in the future, consequently it may be of value to consider the risks of such possibility.

The young children exposure to DIDP will be assessed in two ways:

• without the toy scenario, regarding the present situation,


• with the toy scenario, considering the foreseeable future use of DIDP as a substitute for other phthalates in toys.

Table 4.2 summarises the end products containing DIDP, the sources of exposure and the categories of consumers exposed.

Table 4.2 End products containing DIDP, sources of exposure and categories of consumers exposed

A Adult
I Infants (6 months to 3 years old)
N Newborn babies (0 to 6 months old)

Human internal exposures were calculated tak ing into account the following bioavailability factors as well as differences in oral and inhalation uptake between children and adults:

• oral internal exposure: 50% for adults and 100% for newborns and infants,
  
• inhalation internal exposure: 75% for inhal ation exposure in adults and 100% assu med for newborns and infants.

External and internal exposure for consumer are summarised in Table 4. 3.

Table 4.3 External and internal exposure for consumers

a) A bioavailability of 75% is considered for the inhalation route in adults b) A bioavailability of 50% is considered for the oral route in adults
c) A bioavailability of 100% is considered for infants 6 months to 3 years old and for new-borns 0 to 6 months old by oral and respiratory routes
* Concentration in air"

Source & © : ECB "2003 Risk Assessment Report (RAR 041) on
Di-"isodecyl" Phthalate (DIDP), Summary of the Report,
chapter 4: Human Health

For more information, see the full ECB Risk Assessment Report:
Chapter 4: Environment

DINP

"Consumer exposure

The main difficulty in assessing the level of consumer exposure to DINP is the ubiquity of this compound. As DINP is not chemically bound to PVC, it can be released during the entire cycle of life of end products that are used by consumers. These end products are building materials (cables, floor covering, paints, etc.), car undercoating, clothes, gloves, shoes and boots, etc. DINP has also been found in toys and child care articles. But DINP is not available to consumers as such. Consumer exposure may also occur through food and drinking because of contamination from packaging and processing equipment containing DINP.

Table 4. 2 sum marises the end products containing DINP, the sources of exposure and the categories of consu mers exposed.

Table 4.2 End products containing DINP, sources of exposure and categories of consumers exposed

A Adult
I Infants (6 months to 3 years old)
N Newborn babies (0 to 6 months old)

Human internal exposures were calculated taking into account the following bioavailability factors as well as differences in oral and inhalation uptake between children and adults:

• oral internal exposure: 50% for adults and 100% for newborns and infants,


• inhalation internal exposure: 75% for inhal ation exposure in adults and 100% assu med for newborns and infants.

External an d internal ex p osure for c onsu mer are sum marised in Table 4. 3.

Table 4.3 External and internal exposure for consumers

Sources	External and internal exposure
	Adults		New-borns 0–6 months old		Infants 6 months – 3 years old
	External exposure	Internal exposure µg/kg/d	External exposure	Internal exposure µg/kg/d	External exposure	Internal exposure µg/kg/d
Building materials and furniture	40 µg/m3*	8.3 a)	40 µg/m3*	42.6 c)	40 µg/m3*	42.6 c)
Car and public transport interiors	40 µg/m3*	1.7 a)	40 µg/m3*	3.9 c)	40 µg/m3*	3.9 c)
Gloves, clothes and footwear		0.7	Not estimated
Food and food -related uses	0.2 µg/kg/d	0. 1 b)	2.4 µg/kg/d	2.4	2.3 µg/kg/d	2.3
Total without toys		10.8		48.9		48.8
Toys and teething rings: Oral exposure			200	200 c)	200 c)	200 c)
Dermal exposure				1		1
Total with toys				249.9		249.8

a) A bioavailability of 75% is considered for the inhalation route in adults b) A bioavailability of 50% is considered for the oral route in adults
c) A bioavailability of 100% is considered for infants 6 months to 3 years old and for new-borns 0 to 6 months old by oral and respiratory routes
* Concentration in air"


Source & © : ECB "2003 Risk Assessment Report (RAR 046) on
Di-"isononyl" Phthalate (DINP), Summary of the Report,
chapter 4: EHuman Health


For more information, see the full ECB Risk Assessment Report:
Chapter 4: Human Health

4.3 What are the estimated overall exposures to DIDP and DINP?

DIDP

"Humans exposed via the environment

Adults

Based on the regional concentrations, the total daily intake for humans is 0.002 mg/kg bw/d.

Infants (0.5 – 3 years old)

Based on the regional concentrations, the total daily intake for infants is 0.013 mg/kg bw/d.

Combined exposure

Internal exposure for adults, children and infants are presented in Table 4. 4.

Table 4.4 Internal exposure for adults, children and infants

a) maximum daily intake of 0.027 derived from the use of DIDP in PVC, taking into account 50 % bioavailability for adults
b) maximum daily intake of 0.17 derived from the use of DIDP in PVC, taking into account 100 % bioavailability for infants."

Source & © : ECB "2003 Risk Assessment Report (RAR 041) on
Di-"isodecyl" Phthalate (DIDP), Summary of the Report,
chapter 4: Human Health

For more information, see the full ECB Risk Assessment Report:
Chapter 4: Human Health

DINP

"Humans exposed via the environment

Adults

The estimated maximum total daily intake of 0.028 m g/kg bw/d will therefore also be used in the risk characterisation.

Infants (0.5-3 years old)

The estimated maximum total daily intake of 0.156 mg/kg bw/d will there fore also be used in the risk characterisation.

Combined exposure

Internal exposure for adults, children and infants are presented in Table 4. 4.

Table 4.4 Internal exposure for adults, children and infants"

Source & © : ECB "2003 Risk Assessment Report (RAR 046) on
Di-"isononyl" Phthalate (DINP), Summary of the Report,
chapter 4: EHuman Health

For more information, see the full ECB Risk Assessment Report:
Chapter 4: Human Health