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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 272-902-4 | CAS number: 68919-76-6
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: expert report
- Adequacy of study:
- key study
Data source
Reference
- Reference Type:
- other: expert report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Based on all available information no final conclusion on a bioaccumulation potential can be drawn but there is no evidence that 400112 would have an accumulation potential.
- Executive summary:
The substance 400112 is a complex mixture of components (UVCB), it is liquid at room temperature. In the following table some physical-chemical properties of 400112 are listed:
Molecular weight: 348 – 614 Da
Water solubility: < 0.1 mg/L
Boiling point: substance decomposes before boiling
Log Pow: > 6
Vapour pressure: 1.1 x 10-5 Pa at 25°C
The available physical-chemical information of the substance has been evaluated in combination with results from toxicological studies to assess the toxicokinetic behaviour. The ECHA “Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance 2017” document provides guidance, which physical-chemical properties commonly determine dermal, oral and respiratory absorption, distribution, metabolism and elimination of substances.
Dermal absorption
The substance 400112 is a complex mixture of components with a broad range of molecular weight distribution. Molecules with MW < 500 Da may be absorbed through the skin. However, the low water solubility and the lipophilic properties of the substance (log Pow > 6) are expected to limit absorption across the skin.
Due to its skin irritation potential that led to scab of rat skin in the acute dermal toxicity study (24 hours occlusive exposure) damage of the skin surface may enhance penetration. However, no systemic toxic effects were observed in this dermal toxicity study.
Oral absorption
The low water solubility and the lipophilic properties of the substance 400112 are expected to limit its absorption in the digestive tract. In the repeated dose study (OECD 421) with oral gavage dosing at 20, 60, and 200 mg/kg/d several animals died after 11 to 41 days of continuous exposure at 60 or 200 mg/kg/d. Systemic toxic effects were not observed in these and all surviving animals. Lesions in the stomach and gastrointestinal tract were observed in dead animals very likely being the reason of death. In all surviving animals no lesions were observed at scheduled necropsy.
From these results no conclusion can be drawn on absorption of 400112 after oral exposure. In any case the surface active / corrosive properties of the substance led to severe local effects in the gastrointestinal tract very likely causing death of several animals at repeated oral doses of 60 or 200 mg/kg/d. The substance 400112 is classified STOT RE 2 after oral exposure.
Respiratory absorption
The substance 400112 has a very low vapour pressure and decomposes before boiling. In addition, the substance is a viscous liquid and thus formation of inhalable aerosols is rather unlikely. Accordingly, inhalation is an unlikely route of human exposure.
Distribution and metabolism
There is no information available on distribution and metabolism of 400112 in the available studies.
Excretion
There is no information available on excretion of 400112 in the available studies.
Bioaccumulation potential
Based on all available information no final conclusion on a bioaccumulation potential can be drawn but there is no evidence that 400112 would have an accumulation potential.
In the sub-chronic oral toxicity study in rats (OECD 408) at doses of 5, 15, and 45 mg/kg body weight/day one animal (1/30) of the high dose group died after 78 days of exposure. This death was considered treatment related; the reason for death is not known. In all surviving animals including high dose animals no local and no systemic adverse effects were observed. In another repeat dose oral toxicity study (OECD 421) with doses of 20, 60, and 200 mg/kg/d, at 60 mg/kg/d 3/24 animals and at 200 mg/kg/d 7/24 animals died between treatment days 11 to 41. In almost all dead animals lesions of the stomach and/or gastrointestinal tract were observed. Based on the surface active / corrosive properties of 400112 it is rather likely that the local effect on the intestines was the reason for the death of animals. In animals surviving until scheduled end of the study no systemic or local toxic effects were observed.
The result of the sub-chronic toxicity study provides evidence that 400112 very likely does not have an accumulation potential. Otherwise, it could be expected that after daily dosing for 90 days 400112 would accumulate in certain tissues reaching concentrations that would exhibit corrosive or at least irritating effects. However, no such effects were observed.
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.