Registration Dossier
Registration Dossier
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EC number: 216-503-5 | CAS number: 1603-41-4
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1974
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Well documented study, followed scientific methods and principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- The Teratogenesis Of Nicotinamide Analogs In The ICR Mouse
- Author:
- Morimoto, R. I. and Bederka, J.P. JR
- Year:
- 1 974
- Bibliographic source:
- TERATOLOGY 9:29A-30A,1974.
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study investigated the maternal and developmental effcets after treatment of pregnant mice (i.p.) on gestation days 7, 9, 11, 13 or 15 with 2-Amino-5-methylpyridine.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 5-methyl-2-pyridylamine
- EC Number:
- 216-503-5
- EC Name:
- 5-methyl-2-pyridylamine
- Cas Number:
- 1603-41-4
- Molecular formula:
- C6H8N2
- IUPAC Name:
- 5-methylpyridin-2-amine
- Reference substance name:
- 2-amino-5-methylpyridine
- IUPAC Name:
- 2-amino-5-methylpyridine
- Test material form:
- not specified
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No other deatils on test animals and environmental conditions were provided.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- not specified
- Details on exposure:
- The test substance was administered using ip.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Details on mating procedure:
- No data
- Duration of treatment / exposure:
- 7 or 9 days
- Frequency of treatment:
- Gestation Day 7, 9, 11, 13 or 15.
- Duration of test:
- No data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
No data
Basis:
no data
- No. of animals per sex per dose:
- No data.
- Control animals:
- not specified
- Details on study design:
- No further details on study design is provided in the report.
Examinations
- Maternal examinations:
- No data
- Ovaries and uterine content:
- No data
- Fetal examinations:
- - Absence of fetal toxic and teratogenic effects.
No other details were provided.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified - Changes in number of pregnant:
- not specified
- Other effects:
- not specified
- Details on maternal toxic effects:
- Maternal toxic effects: No data
Details on maternal toxic effects: No data
Effect levels (maternal animals)
- Dose descriptor:
- other: Doses were not provided in the report.
- Basis for effect level:
- other: developmental toxicity
- Remarks on result:
- other: Doses were not provided in the report.
- Remarks:
- No NOAEL/LOAEL can be derived.
Maternal abnormalities
- Abnormalities:
- not specified
Results (fetuses)
- Fetal body weight changes:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified - Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects: No effects
Details on embryotoxic / teratogenic effects:
- Absence of fetal toxic and teratogenic effects.
No other details were provided.
Effect levels (fetuses)
- Dose descriptor:
- other: Doses were not provided in the report.
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: developmental effects
- Remarks on result:
- other: Doses were not provided in the report.
- Remarks:
- No NOAEL/LOAEL can be derived for developmental toxicity.
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Intraperitoneal treatment with 2-Amino-5-methylpyridine to pregnant mice did not result in fetotoxicity or teratogenic effects.
- Executive summary:
Intraperitoneal treatment with 2-Amino-5-methylpyridine to pregnant mice did not result in fetotoxicity or teratogenic effects.
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