Draft Toxicological Intake Values for Priority Contaminants in Soil

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Table 51: Summary of oral reference health standards for benzo(a)pyrene, used by different international agencies or developed in the scientific literature

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Jurisdiction	Acceptable risk level	Guideline value	Risk-specific dose¹ (μg/kg bw/day)	Cancer slope factor (per mg/kg bw/day)	Key study²	Critical effects²	Basis of value²	Reference
New Zealand	10^–5		0.0014	7.3	US EPA (1994)	Fore-stomach tumours – mice	US EPA (1994)	MfE (1997; 1999)
New Zealand drinking water	10^–5	0.07	0.022	0.46	Not stated	Not stated	WHO (2003)	MoH (2005)
WHO drinking water	10^–5		0.022	0.46	Clement Associates (1990)	Fore-stomach tumours – mice	Two-stage birth–death mutation model to incorporate the partial lifetime exposure, without corrections for differences in bodyweight	WHO (1998b, 2003)
UK	10^–5		0.02	–	Neal and Rigdon (1967)	Fore-stomach tumours – mice	WHO (1996)	DEFRA and EA (2002)
The Netherlands – current	10^–4 [10^–5]		2 [0.2]	–	Not stated	Not stated	Vermeire (1993)	Baars et al (2001)
The Netherlands – proposed³	10^–4 [10^–5]		0.5 [0.050]	–	Culp et al (1998), Kroese et al (2001)	Fore-stomach tumours – mice, rats	Kroese et al (2001)	Baars et al (2001)
US	10^–6 [10^–5]		0.00014 [0.0014]	7.3	Neal and Rigdon (1967), Brune et al (1981)	Fore-stomach tumours – mice Fore-stomach tumours – rats	Geometric mean of four slope factors obtained by differing modelling procedures, using the two studies. Animal to human bodyweight to the 2/3 power was applied	US EPA (1994)
California	10^–6 [10^–5]		0.00011 [0.0011]	9.03	Neal and Rigdon (1967)	Fore-stomach tumours – mice	Risk estimate determined from Global86 computer model. Animal to human bodyweight to the ¾ power was applied	CalEPA (1997)
Canada	10^–6 [10^–5]		0.000435 [0.00435]	2.3	Neal and Rigdon (1967)	Fore-stomach tumours – mice	“Robust linear extrapolation with a surface area correction”	CCME (2008)
Norwegian Food Control Authority	10^–6 [10^–5]		0.00057 [0.0057]		Culp et al (1998)	Fore-stomach tumours – mice	Linear extrapolation from BMD₂₅ (the dose that results in tumour incidence in 25% of animals), and interspecies scaling factor of bodyweight to the ¾ power	EC (2002)
US⁴	10^–6 [10^–5]		0.00083 [0.0083]	1.2	Culp et al (1998)	Fore-stomach tumours – mice	US EPA standard method – low-dose linear extrapolation Upper-bound estimate of the slope factor determined by linear extrapolation from the dose estimated to produce an excess tumour incidence of 10% (BMD₁₀ from monotonic multi-stage modelling), and interspecies dose scaling of bodyweight to the ¾ power	Gaylor et al (2000)
The Netherlands⁴	10^–6 [10^–5]		0.005 [0.050]	–	Culp et al (1998), Kroese et al (2001)	Fore-stomach tumours – mice Tumour-bearing animals – rats	“Virtually safe dose” – linear extrapolation from lowest dose level associated with a significant increased tumour response for an acceptable increased risk level of 1 in a million	Kroese et al (2001)
Australia⁴			0.080		Culp et al (1998)	Fore-stomach tumours – mice	Modified benchmark dose (NHMRC, 1999) – maximum likelihood estimates of the dose level giving rise to an excess tumour incidence of 5% (BMD₀₅, as determined from a variety of models), divided by a factor of 4,500 to account for various uncertainties (5 for interspecies extrapolation, 10 for intraspecies variability, 2 for database (in)adequacy, 9 for malignancy, 5 for genotoxicity)	Fitzgerald et al (2004)

1 Where the acceptable risk level for a given jurisdiction is not 10^–5, the risk-specific dose for a risk of 10^–5 is shown in square brackets.
2 As reported in the references cited in the reference column.
3 This value is yet to be officially adopted.
4 These are values developed in the scientific literature, as opposed to values developed for regulatory purposes.

Table 52: Summary of oral reference health standards for benzo(a)pyrene in a PAH mixture, used by different international agencies or developed in the scientific literature

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Jurisdiction	Acceptable risk level	Risk-specific dose¹ (μg/kg bw/day	Cancer slope factor (per mg/kg bw/day)	Key study²	Critical effects²	Basis of value²	Reference
Joint FAO/WHO Expert Committee on Food Additives (JECFA)	[10^–5]	³ [0.0014]	BMDL₁₀ = 0.1 mg/kg bw/day (6.7)	Culp et al (1998)	Fore-stomach tumours – mice	Eight different statistical models were fitted to the combined data for two coal tar mixtures – BMDL₁₀ ranged from 0.1 to 0.23 mg BaP/kg bw/day, with the lower end of this range used in the evaluation by JECFA	FAO/WHO (2006b)
EU Scientific committee on food (SCF)	10^–6 [10^–5]	0.00006–0.0005 [0.0006–0.005]	–	Alexander Knutsen (2001), Kroese et al (2001)	Fore-stomach tumours – mice	Application of carcinogenic potency factor of 10 to “virtually safe doses” established for BaP by Kroese et al (2001) (0.5 ng/kg bw/day), and Alexander and Knutsen (2001) (0.06 ng/kg bw/day), to account for the carcinogenic potency of a mixture of PAHs Stated to be in agreement with that determined by Schneider et al (2002) Note: the SCF expressed reservations regarding the use of mathematical modelling for substances that are genotoxic and carcinogenic and concluded that exposures from food should be as low as practically achievable	EC (2002)
Germany⁴	10^–6 [10^–5]	0.00009 [0.0009]	11.5	Culp et al (1998)	Fore-stomach tumours – mice, rats arising from exposure to coal tar	Arithmetic mean of four estimates of slope factors of the potency of two coal tar mixtures determined using linearised multi-stage modelling and low-dose linear model using the dose estimated to produce an excess tumour incidence of 10% as the point of departure and accounting for bodyweight adjustment by caloric demand – allometric scaling	Schneider et al (2002)

Jurisdiction

Acceptable risk level

Risk-specific dose¹ (μg/kg bw/day

Cancer slope factor (per mg/kg bw/day)

Key study²

Critical effects²

Basis of value²

Reference

Joint FAO/WHO Expert Committee on Food Additives (JECFA)

[10^–5]

³
[0.0014]

BMDL₁₀ = 0.1 mg/kg bw/day
(6.7)

Culp et al (1998)

Fore-stomach tumours – mice

Eight different statistical models were fitted to the combined data for two coal tar mixtures – BMDL₁₀ ranged from 0.1 to 0.23 mg BaP/kg bw/day, with the lower end of this range used in the evaluation by JECFA

FAO/WHO (2006b)

EU Scientific committee on food (SCF)

10^–6
[10^–5]

0.00006–0.0005
[0.0006–0.005]

–

Alexander Knutsen (2001), Kroese et al (2001)

Fore-stomach tumours – mice

Application of carcinogenic potency factor of 10 to “virtually safe doses” established for BaP by Kroese et al (2001) (0.5 ng/kg bw/day), and Alexander and Knutsen (2001) (0.06 ng/kg bw/day), to account for the carcinogenic potency of a mixture of PAHs

Stated to be in agreement with that determined by Schneider et al (2002)

Note: the SCF expressed reservations regarding the use of mathematical modelling for substances that are genotoxic and carcinogenic and concluded that exposures from food should be as low as practically achievable

EC (2002)

Germany⁴

10^–6
[10^–5]

0.00009
[0.0009]

11.5

Culp et al (1998)

Fore-stomach tumours – mice, rats arising from exposure to coal tar

Arithmetic mean of four estimates of slope factors of the potency of two coal tar mixtures determined using linearised multi-stage modelling and low-dose linear model using the dose estimated to produce an excess tumour incidence of 10% as the point of departure and accounting for bodyweight adjustment by caloric demand – allometric scaling

Schneider et al (2002)

1 Where the acceptable risk level for a given jurisdiction is not 10^–5, the risk-specific dose for a risk of 10^–5 is shown in square brackets.
2 As reported in the reference cited in the reference column.
3 Derived in the current study from the BMDL₁₀ of 0.1 mg/kg bw/day determined by FAO/WHO (2006a; 2006b), using low-dose linear extrapolation (slope factor = 0.1/BMDL₁₀) of US EPA (2005) and cross-species scaling to the ¾ power, ie, slope factor (humans) = 10^–5 x (mouse slope factor x (70/0.035)^{1 – 0.75}).
4 These are values developed in the scientific literature, as opposed to values developed for regulatory purposes.