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EC number: 946-756-3 | CAS number: -
Toxicological information
Developmental toxicity / teratogenicity
Currently viewing:
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: Effect of Conjugated Linoleic Acid (CLA) on rat development and growth.
- Short description of test conditions: The test item was administered to female animals after mating in concentrations of 0.25 g/100 g diet or 0.5 g/100 g diet in the diet. The pups received the test item via mother milk or via food after weaning.
- Parameters analysed / observed: CLA content in rat milk, CLA tissue concentrations in dams and fetusses, weight (gain), - GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Linoleic acid
- EC Number:
- 200-470-9
- EC Name:
- Linoleic acid
- Cas Number:
- 60-33-3
- Molecular formula:
- C18H32O2
- IUPAC Name:
- octadeca-9,12-dienoic acid
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Fisher
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Sprague Dawley, Indianapolis, USA
- Age at study initiation:
Experiment I: 8 weeks
Experiment II: 10 weeks
- Housing: individually
- Diet: nonpurified diet (Ralston Purina, St. Louis, MO, USA)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
CLA was mixed in corn oil before addition to the diet.
DIET PREPARATION
- Rate of preparation of diet: weekly
- Mixing appropriate amounts with: basal diet
- Storage temperature of food: +4 °C (under nitrogen to prevent autooxidation)
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused
- M/F ratio per cage: 1/1
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy. - Duration of treatment / exposure:
- up to 10 weeks
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: g/100 g diet
- Remarks:
- Control diet (CD)
- Dose / conc.:
- 0.25 other: g/100 g diet
- Remarks:
- control diet with CLA
- Dose / conc.:
- 0.5 other: g/100 g diet
- Remarks:
- control diet with CLA
- Dose / conc.:
- 0.5 other: g/100 g diet
- Remarks:
- CD during gestation, CLA during lacation
- Control animals:
- yes, plain diet
Examinations
- Maternal examinations:
- BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
- Time schedule for examinations: weekly
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20, 10 animals of each group
- Organs examined: liver, mammary gland, skeletal muscle and abdominal adipose tissues were then removed. Fetuses were removed, weighed and examined visually for abnormalities.
OTHER:
Collection of individual milk samples at d10 of lactation. Total protein in milk was determined.
Quantification of RNA and DNA from mammary glands was performed. - Statistics:
- Data were analysed by ANOVA. Significant differences among means were determined by Tukey's comparisons.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- not examined
- Pre- and post-implantation loss:
- not examined
- Total litter losses by resorption:
- not examined
- Early or late resorptions:
- not examined
- Dead fetuses:
- not examined
- Changes in pregnancy duration:
- not examined
- 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 examined - Changes in number of pregnant:
- not examined
- Other effects:
- not examined
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 0.5 other: g/100 g
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): effects observed, treatment-related
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): Pups which received CLA during gestation and lactation showed a significant increase of body weight compared to control pups. - Reduction in number of live offspring:
- not examined
- Changes in sex ratio:
- not examined
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- not examined
- Visceral malformations:
- not examined
- Other effects:
- not examined
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 0.5 other: g/100 g
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Applicant's summary and conclusion
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