Registration Dossier
Registration Dossier
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EC number: 200-562-9 | CAS number: 63-68-3
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1982
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: No GLP or guideline followed. This study focussed on non-typical endpoints, which are normally investigated in standard fertility studies. Isomer not specified. Only one dose tested.
Data source
Reference
- Reference Type:
- publication
- Title:
- The Effects of Excess Amino Acids on Maintenance of Pregnancy and Fetal Growth in Rats
- Author:
- Matsueda S & Niiyama Y
- Year:
- 1 982
- Bibliographic source:
- J Nutr Sci Vitaminol 28, 557-573
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- see below
- GLP compliance:
- no
Test material
- 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): methionine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Virgin Sprague-Dawley rats (weighing about 160 g) were given 20% casein diet until they weighed about 190 g. After mating with males of the same strian, day 1 of pregnancy was assessed by daily examination of vaginal smears.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- Experiment 1: 14 days
Experiment 2: 21 days - Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5%
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- -Feeding of pregnant rats ad libitum 6% casein diet with an excess (5%) of methionine
- Experiment 1 Effect of amino acid excess diet on maintenance of pregnancy: Two pregnant animals were killed on day 14 of pregnancy and the uterus, amniotic fluid, placenta and foetuses were weighted.
- Experiment 2 Effect of excess of a single amino acid on nitrogen balance of the dams and the free amino acid concentrations in maternal plasma and foetal brain and foetal growth: The pregnant rats got basal or experimental diet ad libitum during pregnancy (21 days). Foetal resorption due to reduced food intake was pervented by injection of estrone and progestrone. To determine nitrogen balance urine and faces were collected.
- Body weight and food intake measured daily
Examinations
- Parental animals: Observations and examinations:
- Blood samples to deterimine free amino acids were taken after anesthetizing the aminal. Afterwards the animals were killed. Products of conception were weighted and the brains of foetuses were stored in a freezer for measurement of nucleic acids, proteins and free amino acids. Lipid concentration of dried carcass was measured gravimetrically.
- Oestrous cyclicity (parental animals):
- not examined
- Sperm parameters (parental animals):
- not examined
- Postmortem examinations (parental animals):
- see above
- Statistics:
- not further specified
Results and discussion
Results: F1 generation
Details on results (F1)
In experiment 2, in treated rats the weight gain and the maternal body weights were significantly lower as comparable to the control croup.
Compared to the controls, the placenta weight of dosed rats were lower, while the litter size was equal to controls.
The fetal brain weight was significantly lower in treated rats as comparable to the control croup. The relatve methionine concentration of maternal plasma and fetal brain in the 6% casein diet containing 5% methionine was markedly elevated as compared to the control.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Excess methionine resulted in complete loss of fetuses.
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