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EC number: 270-560-0 | CAS number: 68443-84-5
- 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
Skin irritation: not irritating
Eye irritation: not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for grouping of substances and read-across
There are no reliable data available for the irritating properties ofDiPE triisononanoate triethylhexanoate(CAS 68443-84-5). In order to fulfil the standard information requirements set out in Annex IX, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.
In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, 1.5, of Regulation (EC) No 1907/2006, whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.
Irritation/Corrosion
CAS |
68443-84-5 |
--- |
Chemical name |
DiPE triisononanoate triethylhexanoate |
Pentaerythritol C7-C10 Tetraester |
MW |
1053.6 – 1081.59 g/mol |
584.8 – 753.1 g/mol |
Skin irritation |
RA: Pentaerythritol C7-C10 Tetraester |
Experimental result: not irritating |
Eye irritation |
RA: Pentaerythritol C7-C10 Tetraester |
Experimental result: not irritating |
The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoint forDiPE triisononanoate triethylhexanoate(CAS 68443-84-5).
A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Discussion
Skin irritation
Irritation to skin is assessed using data from a study with the structural analoguePentaerythritol C7-C10 Tetraester, which was performed similar to OECD guideline 404 (Robinson, 1991). 0.5 mL of the substance was applied to the shaved skin of three female New Zealand White rabbits for 4 h. Upon removal of the semi-occlusive dressing the treated skin sites were washed with warm water and assessed for erythema and edema according to the Draize scoring system 30 - 60 min, 24, 48, 72 and 96 h later, respectively. The mean score for erythema was 1.3 in two animals and 1.7 in the third animal. Erythema reactions were fully reversible within 4 days. The edema score was 0.3 in all animals and the effects were fully reversible within 48 h. In conclusion, based on the mean scores and the reversibility of the effects,Pentaerythritol C7-C10 Tetraester is not irritating to the skin.
Eye irritation
Eye irritation is assessed using data from a study with the structural analoguePentaerythritol C7-C10 Tetraester, which was performed similar to OECD guideline 405 (Robinson, 1991). 0.1 mL of pure substance was instilled into the eyes of three female New Zealand White rabbits followed by observations for three days. Since the scores for cornea, iris, conjunctivae and chemosis were 0 for all time points and in all animals, respectively,Pentaerythritol C7-C10 Tetraester is not irritating to the eyes.
In conclusion, the available data on the analogue substances indicate that DiPE triisononanoate triethylhexanoate is also not irritating to skin and eyes.
Justification for selection of skin irritation / corrosion endpoint:
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).
Justification for selection of eye irritation endpoint:
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).
Justification for classification or non-classification
The available data on skin and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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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