Registration Dossier
Registration Dossier
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EC number: 215-693-7 | CAS number: 1344-37-2 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77603.
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on generations indicated in Effect levels (migrated information)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Opinion of the European Food Safety Authority on lead in food
Data source
Reference
- Reference Type:
- publication
- Title:
- Scientific Opinion on Lead in Food
- Author:
- European Food Safety Authority (EFSA)
- Year:
- 2 010
- Bibliographic source:
- EFSA Journal 2010; 8(4):1570
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- not applicable
Test material
- Reference substance name:
- Lead
- EC Number:
- 231-100-4
- EC Name:
- Lead
- Cas Number:
- 7439-92-1
- Details on test material:
- Not applicable
Constituent 1
Test animals
- Species:
- other: not applicable
- Strain:
- other: not applicable
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Not applicable
Administration / exposure
- Route of administration:
- other: not applicable
- Type of inhalation exposure (if applicable):
- other: not applicable
- Vehicle:
- other: not applicable
- Details on exposure:
- Not applicable
- Details on mating procedure:
- Not applicable
- Details on analytical verification of doses or concentrations:
- Not applicable
- Duration of treatment / exposure:
- Not applicable
- Frequency of treatment:
- Not applicable
- Details on study schedule:
- Not applicable
- No. of animals per sex per dose:
- Not applicable
- Details on study design:
- Not applicable
- Positive control:
- Not applicable
Examinations
- Parental animals: Observations and examinations:
- Not applicable
- Oestrous cyclicity (parental animals):
- Not applicable
- Sperm parameters (parental animals):
- Not applicable
- Litter observations:
- Not applicable
- Postmortem examinations (parental animals):
- Not applicable
- Postmortem examinations (offspring):
- Not applicable
- Statistics:
- Not applicable
- Reproductive indices:
- Not applicable
- Offspring viability indices:
- Not applicable
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
Results: F1 generation
Details on results (F1)
Effect levels (F1)
open allclose all
- Dose descriptor:
- other: BMDL01
- Generation:
- F1
- Effect level:
- 0.5 other: µg/kg bw/d
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Neurobehavioural development (loss of 1 IQ-point)
- Dose descriptor:
- other: BMDL01
- Generation:
- F1
- Effect level:
- 1.2 other: ug/dL blood
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Neurobehavioural development (loss of 1 IQ-point)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on effects on neurobehavioural performance after pre-natal and post-natal exposure, EFSA estimated a BMDL01 of 1.2 ug/dL blood or 0.5 ug/kg body weight/day. This value must be regarded as a DMEL for "minimal" IQ loss due to neurodevelopmental toxicity.
- Executive summary:
The Panel on Contaminants in the Food Chain (CONTAM Panel) of the European Food Safety Authority prepared an opinion on the risk of lead exposure via the food. Based on the available data it is concluded that effects on neurobehavioural performance after pre-natal and post-natal exposure, are the most critical effects, although a dose-effect relationship was not observed. EFSA used the Bench Mark Dose approach (BMD) to estimate the BMDL01, which is the blood-lead concentration corresponding to the 1-percentile of the Confidence Interval of the chosen Bench Mark Response of an IQ deficit of 1 IQ point. The BMR is chosen and set at 1 IQ point by the CONTAM panel of EFSA. Using this approach, the BMDL01 for lead was estimated to be 1.2μg/dL (mentioned as 12μg/L by EFSA) and must be regarded as a DMEL for “minimal” IQ loss due to neurodevelopmental toxicity. This DMEL can be converted from 1.2 μg/dL to 0.5 μg/kg body weight/day.
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