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EC number: 216-721-0 | CAS number: 1653-19-6
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via inhalation route
- Dose descriptor:
- NOAEC
- 251.5 mg/m³
Additional information
A screening study for reproductive/development toxicity is waived on the basis of the availability of a full study investigating reproductive toxicity in a single generation study in which rats were exposed by the primary exposure route - inhalation.
The reproductive effects of 2,3 dichloro-1,3 butadiene have been assessed in a guideline compliant (OECD Guideline 415) one-generation reproductive study rather than a two generation study as specified in REACH test guidelines. However, in the absence of any adverse findings and the EU indications of moving to replace the 2-generation study with data from a single generation study, it is considered that the study presented here adequately addresses the requirements of this annex point.
The effects of 2,3 dichloro-1,3 butadiene on fertility were investigated in a guideline-compliant (OECD Guideline 415) one generation reproduction toxicity study in which groups of Crl:CD®(SD)IGS BRrats (24/sex/concentration) were exposed by whole body inhalation to vapours at 0, 1, 5, or 50 ppm. Rats were exposed for 6 hours/day during premating (8 weeks; 5 days/week), during cohabitation of mating pairs (up to 2 weeks, 7 days/week), and then post-cohabitation for males and nonpregnant females (approximately 7 days, 7 days/week). The pregnant dams were exposed from conception to implantation (days 0-7 of gestation). In parental rats, no treatment-related effects were observed on mortality, clinical parameters, oestrous cycle and sperm parameters; mating, precoital interval and fertility; gross observations and organ weights. Treatment-related effects evident at 50 ppm were decreased body weight and weight gain, food consumption and efficiency and degeneration of the nasal olfactory epithelium.
No effects on fertility were observed in the study. The no-observed-effect level (NOEL) for reproductive and developmental toxicity was reported as 50 ppm, the highest concentration tested. The NOEL for repeated dose inhalation toxicity in parental rats was 5 ppm based on observations of reduced body weight, bodyweight gain and food consumption parameters, and degeneration of the nasal olfactory epithelial toxicity at 50 ppm (251.5 mg/m3).
Short description of key information:
No effects on fertility were observed in a guideline compliant one-generation reproduction toxicity study in which rats were exposed to 2,3 dichloro-1,3 butadiene by whole body inhalation at concentrations up to 50 ppm. The NOEL for reproductive toxicity was reported as 50 ppm (251.5 mg/m3): the highest dose tested.
Effects on developmental toxicity
Description of key information
No developmental effects were observed in offspring from rats exposed to 2,3 dichloro-1,3 butadiene by inhalation at concentrations up to 50 ppm in a one-generation reproduction toxicity study. The NOEL for developmental toxicity was reported as 50 ppm, the highest dose tested. In a guideline-compliant prenatal developmental toxicity study in which pregnant rats were exposed to 2,3 dichloro-1,3 butadiene by whole body inhalation at concentrations 0,1, 10, or 50 ppm, the NOEL for maternal and developmental toxicity was reported as 10 ppm (50.3 mg/m3) based on decreased maternal body weight gain, food consumption and clinical signs of toxicity and developmental toxicity respectively.
Effect on developmental toxicity: via inhalation route
- Dose descriptor:
- NOAEC
- 50.3 mg/m³
Additional information
The developmental effects of 2,3 dichloro-1,3 butadiene have been assessed in a guideline compliant (OECD Guideline 415) one-generation reproductive study rather than a two generation study as specified in REACH test guidelines. However, in the absence of any adverse findings and the EU indications of moving to replace the 2-generation study with data from a single generation study, it is considered that the study presented here adequately addresses the requirements of this annex point.
The effects of 2,3 dichloro-1,3 butadiene on early embryonic development were investigated in a guideline-compliant one-generation reproduction study in which groups of Crl:CD®(SD)IGS BRrats (24/sex/concentration) were exposed by whole body inhalation to vapours at 0, 1, 5, or 50 ppm. Rats were exposed for 6 hours/day during premating (8 weeks; 5 days/week), during cohabitation of mating pairs (up to 2 weeks, 7 days/week), and then post-cohabitation for males and non-pregnant females (approximately 7 days, 7 days/week). The pregnant dams were exposed from conception to implantation (days 0-7 of gestation). No treatment-related effects were observed on the number of corpora lutea; implantation sites, resorptions, live foetuses; pre- and post implantation loss and foetal weight, sex ratio, and external alterations.
No adverse affects were observed in offspring from rats exposed to 2,3 dichloro-1,3 butadiene by inhalation. The no-observed-effect level (NOEL) for developmental toxicity was reported as 50 ppm, the highest concentration tested.
In a guideline-compliant (OECD Guideline 414) prenatal developmental study, groups of 22 time-mated pregnant female Crl:CD®(SD)IGS BRrats were exposed by whole body inhalation to 2,3 dichloro-1,3 butadiene at 0,1, 10, or 50 ppm for 6 hours per day during gestation days 6-20. No treatment-related maternal mortality or gross post-mortem findings were observed. Maternal toxicity, characterized by statistically significant, treatment-related reductions in body weight, weight gain, and food consumption was observed at 50 ppm. Gasping and laboured breathing were also observed in rats exposed to 2,3 dichloro-1,3 butadiene at 50 ppm. Mean fetal weight was significantly reduced by 6.2 % in foetuses from treated at 50 ppm. No treatment-related malformations or variations were observed: fetal viability, resorptions, sex ratio, and litter size were comparable across all groups.
The maternal and fetal NOELs in rats following inhalation exposures were both considered to be 10 ppm (50.3 mg/m3), based on decreased maternal body weight gain, food consumption and clinical signs of toxicity and developmental toxicity respectively.
Justification for classification or non-classification
There is insufficient evidence to classify 2,3 dichloro-1,3 butadiene for reproductive or developmental toxicity
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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