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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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
Untersuchungen zur Auswirkung von Aminosaurenuberdosierungen auf die Foetalphase bei Ratten.
Author:
Kaemmerer, K. and Aly, Z.H.
Year:
1975
Bibliographic source:
DTW Dtsch Tierarztl Wochenschr; 82 (11) p. 457-460.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Pregnant rats were given high doses of essential amino acids as food supplement during the so-called critical phase from the 10th to the 20th day of pregnancy.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
L-methionine
EC Number:
200-562-9
EC Name:
L-methionine
Cas Number:
63-68-3
Molecular formula:
C5H11NO2S
IUPAC Name:
L-methionine
Details on test material:
- Name of test material (as cited in study report): L-Methionin

Test animals

Species:
rat
Strain:
Wistar
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation:no data
- Weight at study initiation: when mated female rats had a weight between 170 to 190 g
- Fasting period before study:no data
- Housing: individually
- Diet (e.g. ad libitum):no data
- Water (e.g. ad libitum):no data
- Acclimation period:no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22-25°C
- Humidity (%): 60%
- Air changes (per hr):no data
- Photoperiod (hrs dark / hrs light):no data

Administration / exposure

Route of administration:
oral: feed
Details on exposure:
Animals received basal diet from day 1 to day 9 post coitum. From day 10 to day 20 post coitum animals received basal diet supplemented with L-methionine. From day 20 to day 22 animals received again basal diet.
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
Mating was carried out by placing three females into the cage of one male over night and confirmed by the presence of a vaginal plug.
Duration of treatment / exposure:
Animals received L-methionine supplemented feed from day 10 to day 20 post coitum
Control animals:
yes, plain diet

Examinations

Maternal examinations:
weigth gain
Ovaries and uterine content:
The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes
Fetal examinations:
- External examinations: Yes
- Soft tissue examinations: Yes
- Skeletal examinations: Yes
- Head examinations: Yes

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:yes

Details on maternal toxic effects:
food supplemented with L-methionine resulted a reduced food consumption and a reduced weight gain

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:yes

Details on embryotoxic / teratogenic effects:
large doses of L-methionine resulted in skeleton deformations and resorptions

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion