Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 248-469-2 | CAS number: 27458-92-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Dodecan-1-ol
- EC Number:
- 203-982-0
- EC Name:
- Dodecan-1-ol
- Cas Number:
- 112-53-8
- Molecular formula:
- C12H26O
- IUPAC Name:
- dodecan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): 1-dodecanol (from Sigma (# L 5375))
- Analytical purity: 99%
Constituent 1
- Specific details on test material used for the study:
- Purity of the product used: 99% (Sigma L 5375).
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mollegard breeding center
- Age at study initiation: 8 weeks
- Weight at study initiation: Males: x-x g; Females: x-x g
- Housing: singly in steel wire cages
- Diet (e.g. ad libitum): IT chow 101 ad lib.
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10%
- Photoperiod (hrs dark / hrs light): 12h/12h (light was provided from 8 p.m. to 8 a.m.)
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency):
- Mixing appropriate amounts with (Type of food):
- Storage temperature of food: - Details on mating procedure:
- no data
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 14 days (Duration of test: 5 weeks)
- Frequency of treatment:
- permanent by diet
- Details on study schedule:
- After a 14 days dosing period the females were placed together with the males, 1 to 1. Check for mating included inspection for plugs during the morning, at lunch time and during the aftemoon. The day on which a plug was recorded at lunch time or during the afternoon was defined day 0. The day on which a plug was recorded during the morning was defined day 1 in pregnancy. Females, in which no mating was recorded, were kept together with the same male for a 14 days period. If no plug and no indication on pregnancy was found after a 14 days period, the female rat was placed together with an other maie for an 8 days period.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 500 ppm
- Remarks:
- equiv. to 100 mg/kg b.w.
- Dose / conc.:
- 7 500 ppm
- Remarks:
- equiv. to 500 mg/kg b.w.
- Dose / conc.:
- 30 000 ppm
- Remarks:
- equiv. to 2000 mg/kg b.w.
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: based on range finding study
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
Blood was taken on day 37 fromall males
CLINICAL CHEMISTRY
The following parameters were measured: Protein, alkaline phosphatase, alanine aminotransferase, glucose, urea, creatinine, total and free cholesterol, and triglyceride
Hematology
The following parameters were measured: Hematocrit, hemoblogin, total erythrocyte, total leucocytes, differential leucocyte counts - Postmortem examinations (parental animals):
- Total gross pathological examinations were performed on each animal. Corpora lutea and implantations were counted. Organ weight was determined for the liver, kidneys and thymus, testis, epididymides. The following organs were fixed in formalin: Liver, kidneys, adrenals, brain, heart, spleen, ovaries, thymus, and other organs with observed pathological changes. Testis and epididymides were fixed in Bouin's solution.
Ail fixed organs, except thymus, in the control and highest dose group were prepared for histopathological examinations. - Postmortem examinations (offspring):
- Pups killed on day 5 were weighed and examined for external malformations including the head (especially eyes and cleft palate) and then opened to the abdomen and thoracic cave for study of sex and malformations of the internal organs.
- Reproductive indices:
- Pregnancy rate, lenght of gestation, number of implantations sites, corpora lutea, and resorptions
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- 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:
- no effects observed
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A significant (p< 0.05) reduction in plasma freecholestorol was observed in group 3. A significant reduction of plasma triglyceride was observed in group 4. Ail other parameters were at the same level as the control group.
- Organ weight findings including organ / body weight ratios:
- no effects observed
Reproductive function / performance (P0)
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effect observed
Results: F1 generation
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 2 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effect observed
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.