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EC number: 226-285-3 | CAS number: 5343-92-0
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- 1,2 hexanediol
- IUPAC Name:
- 1,2 hexanediol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD (SD) IGS BR
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Limited
- Housing: individually in polypropylene cages with solid floors and stainless steel grid tops
- Diet (e.g. ad libitum): pelleted diet ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23-23°C
- Humidity (%): 40-70%
- Air changes (per hr): at least 15 air changes per hour
- Photoperiod: 12hours light / 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
dose administration was adjusted for most recent bodyweight using dose volume of 5ml/kg bodyweight
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentration of SYM051841129 in the test material formulations was determined by gas
chromatography (GC) using an external standard technique. - Details on mating procedure:
- no data
- Duration of treatment / exposure:
- Animals were dosed with the appropriate concentration between days 5 and 19 of gestation.
- Duration of test:
- females were killed on day 20 of gestation.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg bw
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
30 mg/kg bw
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
100 mg/kg bw
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
300 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 24 females per dose
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale:
Dose levels of 300, 100 and 30 mg/kg bw/day were selected for use on this study based on results of preliminary oral gavage prenatal developmental toxicity study in the rat. In this preliminary study, a dose level of 500 mg/kg bw /day was associated with clear adverse clinical signs ( noisy respiration, including decreased laboured respiration and gasping in one case), that excluded this dosage level from use in this main investigation. At 1000 mg/kg repiratory distress and mortality in two cases. A high dosage of 300 mg/kg bw /day was therefore chosen in anticipation of a degree of toxicity that would not impair the assessment of embryofoetal development. Lower dosages represent approximately three-fold reductions from this high dosage.
- Rationale for animal assignment (if not random):
The females were assigned to treatrnent groups using a randomisation procedure based on stratified body weight to ensure, as far as possible, similar group mean bodyweights for each twatment group.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily for mortality/morbidity
CLINICAL OBSERVATIONS: Yes
- Time schedule:
All females were observed once daily, in the morriing throughout gestation and, additionally, one
hour after dosing, throughout the dosing period, for clinical signs of toxicity.
BODY WEIGHT: Yes
- Time schedule for examinations:
All females were weighed on Days 3, 5,6, 7,8,11, 14, 17 and 20 of gestation.
FOOD CONSUMPTION : Yes
Food consumption for individual animals was recorded for discrete periods throughout the study
on Day 3 to 5, Day 5 to 8, Day 8 to 1 l (or 9 to 1 l), Day 11 to 14, Day 14 to 17 and Day 17 to 20
of gestation.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
Each animal was examined externally and internally for macroscopic abnormalities.
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- 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: all per litter
- Skeletal examinations: Yes: all per litter
- Head examinations: Yes:[all per litter - Statistics:
- Bodyweight, bodyweight change and food consumption: Barlett's test for homogeneity of variance and one way analysis of variance, followed by Dunnet's multiple comparison test or, if unequal variances were observed, on alternative multiple comparison test.
Litter data and litter , placental and foetal weights: Krskal-Wallis non-parametric analysis of variance; and a subsequent pairwise analysis of control value against treated values.
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:
- 300 mg/kg bw/day (nominal)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The daily administration of the test item during the period of organogenesis, at dose levels up to 300 mg/kg, was not associated with any adverse effect on the pregnant rat or on the developing conceptus. The "No Observed Effect Level" (NOEL) for the pregnant female and for embryofoetal survival, growth and development was therefore considered to be 300 mg/kg/day.
The "No Observed Effect Level" (NOEL) is therefore considercd to be 300 mg/kg/day.
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