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Diss Factsheets

Toxicological information

Additional toxicological data

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Administrative data

Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 th May - 29 th July 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, available as an unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Type of study / information:
Bioaccessibility of 208Pb in the aqueous media: artificial gastric fluid , artificial lysosomal fluid, artificial sweat solution, PBS (phosphate buffered saline) and artificial interstitial fluid was determined in a 24 h test. Concentration measurements were made at 2 and 24h by ICP-MS. The limit of detection was 0.5 ug/L Pb. Loading rate 0.1 g/L.

was determined in a 2 hour test with a loading rate of 1g/50 ml (20 g/L) of test substance. A 24 hour test in similar media was also performed at a loading rate of 100 mg/50 ml (2000 mg/L).
Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: OECD No. 29. Guidance document on transformation/dissolution of metals and metal compounds in aqueous media.
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EEC guideline SANCO/3029/99 rev. 4 11/07/2000
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
FC811

Results and discussion

Any other information on results incl. tables

The amounts (µg/L) of 208Pb detected in media incubated with FC811 for 2 hours were: 69191 in artificial gastric fluid, 21876 in artificial lysosomal fluid, 32795 in artificial sweat solution, 25571 in PBS and 1036 in artificial interstitial fluid.The amounts (µg/L) of 208Pb detected in media incubated with FC811 for 24 hours were: 58373 in artificial gastric fluid, 4813 in artificial lysosomal fluid, 8126 in artificial sweat solution, 6985 in PBS and 1120 in artificial interstitial fluid.

Applicant's summary and conclusion

Conclusions:
The amounts (µg/L) of 208Pb detected in media incubated with FC811 for 2 hours were: 69191 in artificial gastric fluid, 21876 in artificial lysosomal fluid, 32795 in artificial sweat solution, 25571 in PBS and 1036 in artificial interstitial fluid.The amounts (µg/L) of 208Pb detected in media incubated with FC811 for 24 hours were: 58373 in artificial gastric fluid, 4813 in artificial lysosomal fluid, 8126 in artificial sweat solution, 6985 in PBS and 1120 in artificial interstitial fluid.
Executive summary:

The amounts (µg/L) of 208Pb detected in media incubated with FC811 for 2 hours were: 69191 in artificial gastric fluid, 21876 in artificial lysosomal fluid, 32795 in artificial sweat solution, 25571 in PBS and 1036 in artificial interstitial fluid.The amounts (µg/L) of 208Pb detected in media incubated with FC811 for 24 hours were: 58373 in artificial gastric fluid, 4813 in artificial lysosomal fluid, 8126 in artificial sweat solution, 6985 in PBS and 1120 in artificial interstitial fluid. The highest concentrations of lead were found in artificial gastric fluid, artificial lysosomal fluid, artificial sweat solution and PBS after incubation with FC811 for 2 hours. The lead concentration in artificial interstitial fluid was marginally higher in media incubated for 24 h with FC811. This study (Pardo martinez, 2010) is considered reliable (2), it is a GLP compliant, guideline study, available as an unpublished report with minor restrictions in design and/or reporting but it is otherwise adequate for assessment.