Registration Dossier
Registration Dossier
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EC number: 936-276-2 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.1 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.03 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
- No reliable and relevant long-term dermal study available
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Worker
Hazard via dermal route - systemic - long-term
Hazard assessment of the substance is based on the most hazardous component, lead. NOEL from rat chronic feeding study of the lead acetate is used to derive DNEL.
Relevant dose descriptor for the endpoint
NOEL = 0.0015 mg/kg bw/day for lead ion, chronic exposure, oral gavage, rat by Krasovkii (1979)
Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B.
Route of exposure (oral vs dermal); bioavailability is assumed to be 100% after oral gavage in mice. The skin absorption is assumed to be 0.1% in humans. The bioavailability of lead is based on observation that dermal absorption was 0.1% in in vitro dermal absorption study (Toner and Roper, 2005)
Corrected dermal NOAEL = oral NOAEL * (ABS oral-rat / ABS derm-rat) * (ABS derm-rat/ABS derm-human)
Corrected dermal NOAEL = oral NOAEL * ABSoral-rat / ABSderm-human
Corrected dermal NOAEL = 0.0015 mg/kg bw/day * (100/ 0.1) = 1.5 mg/kg bw/day
Assessment factors according to ECHA 2012 Guidance R.8 Characterization of dose response to human health
Allometric scaling; rat-human 4
Interspecies - remaining differences 2.5
Intraspecies – workers 5
Exposure duration - chronic study 1
Issues related to dose responses - the starting point for the DNEL calculation is a derived NOAEL - default assessment factor 1
Quality of whole database - default assessment factor 1
Overall AF: 4 x 2.5 x 5 x 1 x 1 x 1 = 50
DNEL worker chronic systemic by dermal route = 1.5 mg/kg bw/day / 50 = 0.03 mg/kg bw/day
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 500 ng/m³
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.004 mg/kg bw/day
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Hazard via oral route – systemic – long-term effects
Meta-analyses of human observational epidemiology data show a statistical association between post-natal blood lead and IQ that is small and most likely between a one to three IQ point deficit for a change in mean blood lead level from 10 µg/dL to 20 µg/dL. Any IQ decrements that might occur at blood lead levels below 10 µg/dL would not be detectable in the individual. Although such effects may lack significance for the individual, an impact upon large numbers of children may have societal significance.
However, observational data suggests that population effects in children may occur at blood lead levels as low as 5 µg/dL. Designation of 5 µg/dL as an epistemic threshold and a “societal blood lead target” also dramatically reduce the probability that individual children might exceed a blood lead level of 10 µg/dL. Thus, for purposes of Risk Characterisation, NOAEL of 5 µg/dL is used to minimize the probability that individual blood lead levels will exceed 10 µg/dL.
Conversion of NOAEL to DNEL.
NOAEL 5 µg lead /dL = 50 µg / L (for large populations of children).
Weight of a child: 20 kg. (European Commission (2001), Guidance on exposure estimation)
Total blood volume in children is 75-80 ml/kg. WHO (2010), Blood sample volumes in child health research: review of safe limits.
Thus, the blood volume of a child is 80 ml/kg * 20 kg = 1600 ml = 1.6 L
Total amount of lead in blood: 50 µg / L * 1,6 L = 80 µg.
DNEL for daily dose (lead in blood per body weight): 80 µg / 20 kg = 4 ug / kg bw = 0.004 mg lead/kg bw
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