Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 216-629-0 | CAS number: 1630-78-0
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- assessment of toxicokinetic behaviour
- Type of information:
- other: In accordance with REACH Annex VIII (8.8) an assessment of toxicokinetic behavior has been conducted to the extent that can be derived from the relevant available information.
- Adequacy of study:
- key study
- Study period:
- The assessment was made in August 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Relevant studies were reviewed with a view to fulfilling the requirements of Annex VIII (8.8).
- Justification for type of information:
- Relevant studies (reliability 1) were reviewed with a view to fulfilling the requirements of Annex VIII (8.8).
- Objective of study:
- toxicokinetics
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- In accordance with REACH Annex VIII (8.8) an assessment of toxicokinetic behaviour has been conducted to the extent that can be derived from the relevant available information. The assessment is based on the Guidance on information requirements and chemical safety assessment R.7c: Endpoint specific guidance (ECHA, June 2017)
- GLP compliance:
- no
- Conclusions:
- The available information on the substance suggests that respiratory absorption may occur following inhalation exposure. Absorbed substance may be available for systemic distribution. There is no evidence to indicate the substance will be metabolized and excretion is likely to be a mixture of exhaled air and urine.
Reference
Toxicokientic assessment:
The substance is a (liquified) gas with a molecular weight of 64.
The substance is classified as a flammable gas.
Inhalation is considered the most likely route of exposure.
The substance has a water solubility of 2.0 g/L and a relatively low log octanol/water partition coefficient (log Kow = 0.9).
There were no significant signs of toxicity observed in an acute inhalation toxicity study.
In repeated dose inhalation toxicity studies (28-day OECD 412 and 90-day OECD 413) there were no test-item related adverse effects indicative of systemic toxicity (including no test-item adverse effects on mortality, clinical observations, body weights, hematology, clinical chemistry, macroscopic necropsy observations and organ weights).
The main findings in the repeated inhalation studies was with neuronal cell degeneration in the vomeronasal organ. The vomeronasal organ is a sensory organ involved in detecting reproductive pheromones. It is well developed in rats and mice but poorly developed or absent in humans and its functionality has not been definitively established. The significance of this finding to humans is not established. This finding may also be considered as a local effect (effect at site of exposure).
In a screening test for reproductive/developmental effects (OECD 421) no effects on reproductive/developmental performance were observed.
The substance was positive (mutagenic) in bacteria (Ames study), negative in in-vitro chromosome aberration and micronucleus tests. The substance was negative in a in-vivo micronucleus test but a Comet assay showed evidence of causing an increase in DNA strand breaks in the bladder, lung, kidney and liver of male Crl:CD (SD) rats when administered via inhalation.
ABSORPTION:
Inhalation is considered the most likely route of exposure and therefore respiratory absorption is considered the most likely route of absorption.
The molecular weight of the substance supports the potential for respiratory absorption. The substances moderate log Kow (between -1 and 4) is favourable for absorption across the respiratory tract epithelium by passive diffusion. The water solubility of the substance is unlikely to preclude respiratory absorption.
Respiratory absorption following inhalation exposure is therefore considered likely to occur.
The results of inhalation toxicity testing (including acute inhalation toxicity and repeated dose toxicity studies) do not provide evidence of significant systemic toxicity (to confirm absorption occurred) but absorption cannot be ruled out based on these results.
Dermal absorption can also be considered as gases can potentially be taken up across the skin.
The molecular weight (less than 100) favours dermal uptake. The water solubility and log Kow may also support some dermal uptake. No skin irritation or dermal toxicity studies are available to assess if damage to skin surface could enhance penetration or if absorption has occurred (i.e. signs of systemic toxicity).
DISTRIBUTION:
The molecular weight of the substance and its high water solubility indicates that any absorbed substance may be readily distributed in the water fraction of circulatory fluids.
No firm conclusion on skin sensitisation could be made based on modelling predictions and no study data is available, so it cannot be concluded if the substance has potential to bind to carrier/circulatory proteins in blood.
The relatively low Log Kow (0.9) suggests the substance is not sufficiently lipophilic to make it likely that it will accumulate within fatty/adipose tissues or deposit in the lungs.
METABOLISM:
The results of repeated dose inhalation toxicity studies did not show evidence to indicate any substance influenced hepatic metabolism.
Although the results of genotoxicity assays showed both positive and negative results, genotoxicity was neither enhanced nor diminished in the presence of S9 metabolising system in the studies.
The water solubility and molecular weight of the substance suggest that metabolism may not be necessary to facilitate excretion.
EXCRETION:
There is no evidence to indicate the route of excretion of the substance.
Gases are likely to be excreted in exhaled air.
Excretion via urine could also be favourable based on the substances molecular weight and water solubility.
Description of key information
The available information on the substance suggests that respiratory absorption may occur following inhalation exposure. Absorbed substance may be available for systemic distribution. There is no evidence to indicate the substance will be metabolized and excretion is likely to be a mixture of exhaled air and urine.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.