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Registration Dossier
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EC number: 435-560-9 | CAS number: 57090-45-6
- 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

Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: Reproductive function and performance
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The result was obtained from a publically available source which has been subject to peer-review and in which the original data sources are traceable.
Data source
Reference
- Reference Type:
- publication
- Title:
- Safety evaluation of certain food additives and contaminants 3-chloro-1,2-propanediol
- Year:
- 2 011
- Bibliographic source:
- WHO FOOD ADDITIVES SERIES: 48
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Not given.
- GLP compliance:
- not specified
- Remarks:
- Details not provided
Test material
- Reference substance name:
- 3-chloropropane-1,2-diol
- EC Number:
- 202-492-4
- EC Name:
- 3-chloropropane-1,2-diol
- Cas Number:
- 96-24-2
- IUPAC Name:
- 3-chloropropane-1,2-diol
- Reference substance name:
- 3-Chloro-1,2-propanediol
- IUPAC Name:
- 3-Chloro-1,2-propanediol
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: CD
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Details on mating procedure:
- Before the kill at day 15, the males were cohabited with untreated females in a 1:2 ratio. The females were killed on presumed gestational day 13 and examined for pregnancy status.
- Duration of treatment / exposure:
- 3-Chloro-1,2-propanediol was administered by gavage to groups of 10 adult male CD rats at a dose of 0, 1, 5, or 25 mg/kg bw per day for 14 days. The animals were killed on day 15 or 29. At necropsy, testis weight, distribution of DNA ploidy in testicular cell suspensions, testicular and epididymal histological appearance, and epididymal sperm concentration, motility, morphology, and breakage were determined.
- Frequency of treatment:
- Daily.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg
Basis:
- Remarks:
- Doses / Concentrations:
1 mg/kg
Basis:
- Remarks:
- Doses / Concentrations:
5 mg/kg
Basis:
- Remarks:
- Doses / Concentrations:
25 mg/kg
Basis:
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Reduced percentage of mobile sperm and decreased fertility
- Remarks on result:
- other: Generation: Unknown (migrated information)
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- other: No offspring
- Generation:
- F1
- Effect level:
- > 0 - <= 1 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No offspring
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The substance impairs fertility in the rat.
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