Registration Dossier
Registration Dossier
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EC number: 231-323-7 | CAS number: 7492-66-2
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from secondary literature
Data source
Reference
- Reference Type:
- secondary source
- Title:
- SCREENING-LEVEL HAZARD CHARACTERIZATION Terpenoid Primary Alcohols and Related Esters Category
- Author:
- U.S. Environmental Protection Agency
- Year:
- 2 009
- Bibliographic source:
- U.S. Environmental Protection Agency September, 2009 Hazard Characterization Document.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 422
- Principles of method if other than guideline:
- Developmental toxicity test was performed on rats by using citral diethylacetal .
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 1,1-diethoxy-3,7-dimethylocta-2,6-diene
- EC Number:
- 231-323-7
- EC Name:
- 1,1-diethoxy-3,7-dimethylocta-2,6-diene
- Cas Number:
- 7492-66-2
- Molecular formula:
- C14H26O2
- IUPAC Name:
- 1,1-diethoxy-3,7-dimethylocta-2,6-diene
- Details on test material:
- 1,1-diethoxy-3,7-dimethylocta-2,6-diene
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: 1,1-diethoxy-3,7-dimethylocta-2,6-diene
- Molecular formula: C14H26O2
- Molecular weight: 226.35 g/mole
- Smiles notation: O(C(OCC)C=C(CCC=C(C)C)C)CC
- Substance type: Liquid
- Physical state: Organic
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- Sex Female
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: Corn oil or methylcellulose
- Details on exposure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data available
- Details on mating procedure:
- - M/F ratio per cage: No data available
- Length of cohabitation: Mention but duration was not given specific
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy No data available
- After … days of unsuccessful pairing replacement of first male by another male with proven fertility. No data available
- Further matings after two unsuccessful attempts: [no / yes (explain)] No data available
- After successful mating each pregnant female was caged (how): No data available
- Any other deviations from standard protocol: No data available - Duration of treatment / exposure:
- approx 46 days.
- Frequency of treatment:
- Daily
- Duration of test:
- 7 days prior to cohabitation and through cohabitation, gestation, delivery and day 4 of lactation
Doses / concentrations
- Remarks:
- 0, 125, 250 and 500 mg/kg-day
- No. of animals per sex per dose:
- No data available
- Control animals:
- not specified
- Details on study design:
- No data available
Examinations
- Maternal examinations:
- Clinical signs, body weight, food consumption and gross lesions examined.
- Ovaries and uterine content:
- No data available
- Fetal examinations:
- Body weights and body weight gains were observed.
- Statistics:
- No data available
- Indices:
- No data available
- Historical control data:
- No data available
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- 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:
- Clinical signs: Clinical signs were observed in treated female rats at 500 mg/kg bw/ day as compared to control.
Body weight: lower body weights and body weight gains were observed at 250 and 500 mg/kg-day as controls.
Reproductive performance: No reproductive toxicity was observed in treated female rats at 125, 250 and 500 mg/kg-day as compared to control.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- clinical signs
- other: No effect
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: reproductive toxicity
Maternal abnormalities
- Abnormalities:
- not specified
- Localisation:
- not specified
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- 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 - 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:
- not specified
- Skeletal malformations:
- not specified
- Visceral malformations:
- not specified
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- Body weight: Lower body weight compared to controls was observed only at 500 mg/kg-day.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- fetal/pup body weight changes
- other: No effect observed
Fetal abnormalities
- Abnormalities:
- not specified
- Localisation:
- other: not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 500 mg/kg-day for p genearrtion and 250 mg/kg-day for F1 generation when Sprague-Dawley female rat were treated with 1,1-diethoxy-3,7-dimethylocta-2,6-diene orally by gavage for approx 46 days.
- Executive summary:
In Combined reproductive/developmental toxicity screening test, Sprague-Dawley female rat were treated with 1,1-diethoxy-3,7-dimethylocta-2,6-diene in the concentration of 0, 125, 250 and 500 mg/kg-day orally by gavage in Corn oil or methylcellulose. Clinical signs and lower body weights and body weight gains were observed at 250 and 500 mg/kg-day as controls. In addition, no reproductive toxicity was observed in treated female rats at 125, 250 and 500 mg/kg-day. But, developmental toxicity was observed as decrease in pups body weight at 500 mg/kg-day. Therefore, NOAEL was considered to be 500 mg/kg-day for p genearrtion and 250 mg/kg-day for F1 generation when Sprague-Dawley female rat were treated with 1,1-diethoxy-3,7-dimethylocta-2,6-diene orally by gavage for approx 46 days.
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