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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
There are no studies concerning toxicity on reproduction available for 1,2 pentanediol. However, oral studies are available for a structural closely related substances such as 1,2 butanediol (OECD 422) and 1,2 hexanediol (OECD 414). Available data is sufficient for a risk and hazard assessment concerning toxicity on reproduction.
A Reproduction / Developmental Toxicity Screening Test was conducted according to OECD Guideline 422 and GLP to evaluate toxicity to reproduction and development is available for 1,2 butanediol (JETOC, 1995). Ten male and ten female Wistar rats per dose received 1,2 butanediol at doses of 40, 200 and 1000 mg/kg/d by gavage. The application period was about seven weeks for males and about six weeks for the females starting at least 14 day before mating. After the mating period, the male animals were sacrificed while the females were allowed to litter and rear their pups until day 4 post partum. Thereafter, the pups (F1-generation) and the F0-females were sacrificed.
Not any reproductive toxicity was observed in parental animals and offspring in doses up to 1000 mg/kg bw. Parameters of copulation, implantation, pregnancy, parturation and lactation did not differ from the control. No abnormal pubs were observed and no loss of offspring occurred. Therefore, the NOAEL for reproductive function and for developmental toxicity was 1000 mg/kg/ bw/day for 1,2 butanediol. Due to the structural similarities, the same result could also be expected for pentane-1,2-diol.
Short description of key information:
Fertility:
- NOAELparent. = 1000 mg/kg bw (OECD 422; Analogy CAS 584-03-2)
-NOAEL F1 = 1000 mg/kg bw (OECD 422; Analogy CAS 584-03-2)
Effects on developmental toxicity
Description of key information
Developmental toxicity:
- NOAELmat. = 300 mg/kg bw ( OECD 414; Analogy CAS 6920-22-5)
- NOAELdevelop/tera = 300 mg/kg bw (OECD 414; Analogy CAS 6920-22-5)
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
Additional information
There are no studies concerning toxicity on reproduction available for 1,2 pentanediol. However, oral studies are available for a structural closely related substances such as 1,2 butanediol (OECD 422) and 1,2 hexanediol (OECD 414). Available data is sufficient for a risk and hazard assessment concerning toxicity on reproduction.
1,2 hexandiol was tested for developmental toxicity in an oral gavage study in rats according to OECD 414 and GLP. 24 pregnant Crl:CD rats received 300, 100 and 30 mg 1,2 hexanediol/kg bw/day daily form day 5 to 19 of gestation. Dose levels were selected for use in this study based on results of a range finding study. 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 respiratory distress and mortality in two cases occurred. 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.
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.
Justification for classification or non-classification
Due to the results obtained in a developmental toxicity screening study performed according to OECD guideline 422 with the structural analogue 1,2 butanediol and in a dermal OECD 414 with the structural analogue 1,2 hexanediol no classification is necessary.
The classification criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 were not met.
Additional information
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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