Registration Dossier

Toxicological information

Toxicity to reproduction

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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:
2010
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
Name:
Unnamed
Type:
Constituent
Details on test material:
Not applicable

Test animals

Species:
other: not applicable
Strain:
other: not applicable
Sex:
not specified
Details on test animals 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 animals)

Details on results (P0)

Not applicable

Results: F1 generation

Details on results (F1)

Not applicable

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.