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EC number: 268-776-5 | CAS number: 68140-14-7
- 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
No data are provided for the submission substance and none are required based on its classification as a skin corrosive. Read-across data are available for the major components (AAI_DETA and Rosin) of DTO_DETA.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- It is considered appropriate to address the data requirements for DTO_DETA by read-across to the available studies on the main components of DTO_DETA: AAI_DETA and Rosin.
DTO_DETA contains comparatively lower levels of imidazolines and higher levels of resin acids than AAI_DETA and therefore consideration of data for resin acids is also considered necessary. The main resin acid in DTO_DETA is abietic acid, but abietic acid derivatives and other acids, such as pimaric acid, are also found in notable quantities, and the resin acids collectively are known as ‘rosin’. DTO_DETA contains up to 25% unreacted rosin, and taking into account the compositional information available for the rosin in DTO_DETA and Rosin (CAS# 8050-09-07, EC# 232-475-7), the latter was considered appropriate for read-across to DTO_DETA.
An LLNA (OECD 429) is available for AAI_DETA (CIT, 2007), the main component in DTO_DETA. Based on the results of this study, AAI_DETA was classified as a Category 1A Skin Sensitiser. A guideline guinea pig maximisation test (NOTOX, 2010) is also available with the read across substance AAI_DETA; this study confirms the result obtained in the LLNA. As AAI_DETA is a major component in DTO_DETA, read across to the AAI_DETA dataset is justified and presents the worst case approach. Several negative studies (LLNAs, guinea pig maximisation tests and a Buehler assay) conducted with Rosins are provided as supporting information; these studies are provided to demonstrate that the Rosin component of DTO_DETA will not significantly increase the hazard profile of DTO_DETA with respect to skin sensitisation. A positive study conducted with Wood Rosin (CTL, 1997g) is available and is included in the dossier for information purposes, however the study was disregarded because the test substance sample was heavily oxidised and degraded. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Parameter:
- EC3
- Value:
- 0.3
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 0.05% test item
- Parameter:
- SI
- Value:
- 1.88
- Test group / Remarks:
- 0.1% test item
- Parameter:
- SI
- Value:
- 1.67
- Test group / Remarks:
- 0.25% test item
- Parameter:
- SI
- Value:
- 5.91
- Test group / Remarks:
- 0.5% test item
- Parameter:
- SI
- Value:
- 18.65
- Test group / Remarks:
- 1% test item
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- Based on the results of the read across study, DTO_DETA is considered to be skin sensitiser. Classification according to CLP is required (Cat 1A Skin Sensitiser).
- Executive summary:
A guideline (OECD 429) LLNA (CIT, 2007) is available for the read across (source) substance, AAI_DETA. Read across from AAI_DETA to the target, DTO_DETA, is considered appropriate because AAI_DETA is a major component of DTO_DETA. AAI_DETA was found to be to a strong skin sensitiser. Therefore, based on the results of this study, DTO_DETA should be classified as a Category 1A Skin Sensitiser according to the CLP Regulation. Several studies (LLNAs, guinea pig maximisation tests and a Buehler assay) are available for the Rosin data set, and are presented as supporting read across information to demonstrate that the Rosin component of DTO_DETA will not significantly increase the hazard profile of DTO_DETA with respect to skin sensitisation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
No data are provided for the submission substance and none are required based on its classification as a skin corrosive. However read-across data are available for the major components (AAI_DETA and Rosin) of DTO_DETA and these are taken into account. Based on a weight of evidence, rosins are not considered to be skin sensitisers.
An LLNA study conducted with AAI_DETA (a major component of DTO_DETA) shows a positive response, DTO_DETA is therefore also considered likely to be a skin sensitiser.
Respiratory sensitisation
Link to relevant study records
- Endpoint:
- respiratory sensitisation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No studies investigating respiratory sensitisation are available and none are required; inhalation exposure is considered highly unlikely based on the physico-chemical properties of one of the major components of DTO_DETA, and as DTO_DETA is classified as corrosive further testing is not justified on animal welfare grounds.
Justification for classification or non-classification
Based on read across to an LLNA study conducted with AAI_DETA (a major component of DTO_DETA), DTO_DETA should be classified as a Category 1A Skin Sensitiser according to the CLP Regulation.
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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