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EC number: 205-457-1 | CAS number: 141-10-6
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD Guideline 415 under GLP, with full report and all individual data.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
- Reference Type:
- secondary source
- Title:
- No information
- Author:
- Beekhuizen MEW
- Year:
- 2 007
- Bibliographic source:
- OECD SIDS, Final 04/2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 415 (One-generation reproductive toxicity)
- Principles of method if other than guideline:
- AccordinhOECD Guideline 415, One-generation reproductive toxicity
- GLP compliance:
- yes
- Remarks:
- NOTOX BV
- Limit test:
- no
Test material
- Reference substance name:
- 6,10-dimethylundeca-3,5,9-trien-2-one
- EC Number:
- 205-457-1
- EC Name:
- 6,10-dimethylundeca-3,5,9-trien-2-one
- Cas Number:
- 141-10-6
- Molecular formula:
- C13H20O
- IUPAC Name:
- 6,10-dimethylundeca-3,5,9-trien-2-one
- Details on test material:
- - Name of test material (as cited in study report): Pseudoionone
- Manufacturer: Teranol AG, Lalden
- Lot/batch No.: UU02033826,
- Analytical purity: 95.4% (area, GC).
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar Crl: (WI) BR (outbred, SPF quality)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: males 5 - 6 weeks old; females 11 - 12 weeks old
- Identification: tattoo on the tail
- Housing: suspended stainless-steel cages, 4 animals per sex per cage, with males and females being kept in separate rooms. Mated females and males were housed individually in labelled polycarbonate cages containing sawdust (SAWI bedding, Jelu-Werk, Rosenberg, Germany) as bedding material. During the final stage of the pregnancy period, from day 16 post coitum, and during lactation, paper (Enviro-dri, BMI, Helmond, The Netherlands) was supplied to the dams for incorporation into the nest. The paper was replaced when soiled.
- Diet (e.g. ad libitum): ad libitum, standard pelleted rat diet (Altromin, code VRF1, Lage, Germany)
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Analyses for all batches of feed and quarter-yearly analyses of tap water are retained at NOTOX archives
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- maize oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
- Pseudoionone was formulated daily - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Formulations were analytically confirmed to be stable for at least 4 hours at room temperature and to correspond to targeted concentrations.
- Details on mating procedure:
- - Impregnation procedure: cohoused
- M/F ratio per cage: 1/1 from same dose group
- Length of cohabitation: until vaginal plug was found; max. 3 weeks
- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy
- After 21 days of unsuccessful pairing pairs were separated.
- After successful mating each pregnant female was caged (how): individually - Duration of treatment / exposure:
- Exposure period: males: mean 106 (range 104-108) days
females: mean 60 (range 36-65) days
Premating exposure period (males): 11 weeks
Premating exposure period (females): 2 weeks
Duration of test: 126 days - Frequency of treatment:
- once daily
- Duration of test:
- Exposure period: males: mean 106 (range 104-108) days;
females: mean 60 (range 36-65) days
Premating exposure period (males): 11 weeks
Premating exposure period (females): 2 weeks
Duration of test: 126 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
40, 120 and 360 mg/kg bw/d
Basis:
nominal conc.
- No. of animals per sex per dose:
- 24
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: dose levels were based on a GLP 28-day subchronic toxicity study with the same dose levels that resulted in a NOEL of 50 mg/kg bw/d and a LOEL of 250 mg/kg bw/d with reversible effects (-> 7.5.1 Strobel1997.Repeated dose toxicity: oral rat 28d)
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: on the first day of exposure and weekly thereafter; Mated females were weighed on days 0, 7, 14 and 21 of gestation and during lactation on days 1, 4, 7, 14 and 21
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption of mated females was recorded on gestation days 0, 7, 14 and 21 and during lactation on days 1, 4, 7, 14 and 21
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes, but only subjective appraisal was maintained
REPRODUCTIVITY
- numbers of animals mated, mating date, confirmation of pregnancy and day of delivery were recorded - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 120 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 360 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
For general results, please refer to Beekhuizen2003.Toxicity to reproduction rat 1 generation
Reproduction
Reproduction parameters were unaffected by treatment up to
360 mg/kg bw/d. In the 40 group, one female did not mate and
one female was non-pregnant. In the 120 group, one female
showed delivery difficulties, and in the 360 group, two
females showed delivery difficulties. Mating performance,
duration of gestation, fertility parameters and number of
pups at birth were similar for the control and treated
groups.
----------------------------------------------------------
Dose group, Litter size, live births, mean bodyweights,
mg/kg bw/d n n g
----------------------------------------------------------
0 mean 14.7 14.5 6.8
SD 2.5 2.72 0.62
n 24 24 24
----------------------------------------------------------
40 mean 15.0 14.1 6.6
SD 2.5 3.98 0.44
n 22 22 21
----------------------------------------------------------
120 mean 15.7 15.1 6.5*
SD 1.3 2.72 0.45
n 23 23 23
----------------------------------------------------------
360 mean 15.4 14.5 6.5
SD 4.5 5.38 0.59
n 23 23 22
----------------------------------------------------------
*: p < 0.05, Dunnett's test on pooled variance.
----------------------------------------------------------
Pups
Development of the pups was unaffected by treatment up to
360 mg/kg bw/d. Numbers of pups at birth were similar
between controls and all treatment groups. No teratogenic
malformations are reported. However, postnatal deaths were
significantly increased at 360 mg/kg bw/d during days 0-4
post partum, due to which the viability index was decreased
in this group (91.0 compared to 96.6 in controls).
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.
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