Registration Dossier
Registration Dossier
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EC number: 261-385-0 | CAS number: 58670-89-6
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- August to November 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD, etc.)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2-octyldodecan-1-ol
- EC Number:
- 226-242-9
- EC Name:
- 2-octyldodecan-1-ol
- Cas Number:
- 5333-42-6
- Molecular formula:
- C20H42O
- IUPAC Name:
- 2-octyldodecan-1-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- According to guideline
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on exposure:
- Test substance is stable in arachidis oil.
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- According to guideline.
- Duration of treatment / exposure:
- day 6 to day 15 of gestation.
- Frequency of treatment:
- daily
- Duration of test:
- until day 20 of gestation.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
100 mg/kg bw
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
300 mg/kg bw
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 24
- Control animals:
- yes
- Details on study design:
- none
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
POST-MORTEM EXAMINATIONS: Yes - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes :
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: half per litter - Statistics:
- yes
- Historical control data:
- no
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: embryotoxicity
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: fetotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- 2-Octyldodecan-1-ol is not cumulatively toxic to pregnant rats and does not reveal embryotoxic, fetotoxic or developmental toxic effects up to 1000 mg/kg bw, the highest dose tested.
- Executive summary:
According to an OECD 414 developmental toxicity study with 2 -octyl-1 -dodecanol, the test substance is not cumulatively toxic to pregnant CD rats and does not reveal embryotoxic, fetotoxic or developmental toxic effects up to 1000 mg/kg bw, the highest dose tested.
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