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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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Diss Factsheets
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EC number: 943-366-5 | CAS number: -
- 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
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No specific studies have been conducted for the target substance. The substance is composed of acetic anhydride (5-10 wt. %), adipic acid, di-anhydride with bis(acetic acid) (50 -62 wt. %) and acetic acid (30-35 wt. %).The weight of evidence approach is used to determine the sensitization properties of the target substance evaluating relevant data from the constituent of the target substance and from the decomposition products. However, very limited amount of data is available.
No reliable study is conducted for acetic anhydride. In one report local response claimed to be indicative of a sensitization reaction (Jacobs, J.L, 1940). In the study guinea pigs were given twice weekly intracutaneous injections of 0.05 ml of a solution in olive oil for 2-2.5 weeks.However, the report is of poor quality and the documentation is not sufficient for assessment.
There is only one sensitisation study available for adipic acid. It produced no evidence of a sensitising action. Groups of 10 guinea pigs were given series of four sacral intradermal injections, one each week over a three-week period, which consisted of 0.1 ml of a 1.0 % solution of adipic acid (99.99 %) in water. Following a two-week rest period, the test animals were challenged for sensitisation by applying, and lightly rubbing in, approximately 0.05 ml of a 50 % and 25 % suspension of the test material in propylene glycol on the shaved intact shoulder skin. A group of 10 previously unexposed animals received similar applications at the time of challenge to provide direct comparison of the challenge reactions on the skin of similar age. The compound produced very mild to no skin irritation to previously unexposed guinea pigs and did not cause sensitisation (OECD; SIDS (2003).
Migrated from Short description of key information:
No data is available to assess sensitization potential of the target substance. Due to corrosive properties of the target substance and decomposition products further skin sensitization testing would be difficult to justify.
Justification for selection of skin sensitisation endpoint:
No single study was selected since weight of evidence is used to assess the sensitisation properties of the target substance
Justification for classification or non-classification
The target substance is not classified for skin sensitization in accordance to the CLP Regulation No. 1272/2008.
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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