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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles. Non-standard treatment regimen.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2006

Materials and methods

Principles of method if other than guideline:
Maternal rats were exposed to lanthanum from gestation day 0 through postnatal day 20. From postnatal day 20, pups were exposed to Lanthanum until postnatal day 150. Physical and neurobehavioural development of the pups was recorded, the DNA and protein/DNA concentrations were determined at postnatal day 30 and the Morris water mate test was conducted at postnatal day 150.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Lanthanum Chloride
- Molecular formula (if other than submission substance): LaCl3
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Wistar
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Animal Center of Beijing Medical University
- age: 7-9 weeks
- Housing: 5 in a polycarbonate cage

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
other: oral: probably gavage
Vehicle:
not specified
Analytical verification of doses or concentrations:
no
Details on mating procedure:
- Female rats were mated with males of the same age and strain
- Proof of pregnancy: vaginal plug [day 0] of pregnancy
- No information about: length of cohabitation, success of copulation
- After successful mating each pregnant female was caged individually
Duration of treatment / exposure:
Dams: from gestation day 0 through postnatal day 20
Pups: from postnatal day 20 until they were killed (postnatal day 150)
Frequency of treatment:
probably daily during treatment period
Duration of test:
150 days
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 0.1, 2 and 40 mg/kg/day
Basis:
nominal conc.
No. of animals per sex per dose:
15 maternal rats/dose
a total of 30 pups (equal numbers of males and females when possible) per dose
Control animals:
yes, concurrent no treatment

Results and discussion

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
40 mg/kg bw/day (nominal)
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

- No differences in litter size between groups.

- No differences in pinna detachment and eye opening between groups.

- Body weights showed no significant differences among all groups on the 0 day. Compared to other groups, although no significant difference was observed, the body weight of the 2 mg/kg group was elevated on PND0 and PND30, with a significant difference on PND90. However, the weight gain of the 40 mg/kg group was decreased at all ages, with a significant difference at 5 months. This was not regarded a biologicallly significant effect.

Applicant's summary and conclusion