Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: - | 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
Not sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- performed 2016
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2016-01-12 to 2016-03-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented GLP compliant study report. The Maximization test was selected since the test item is a surfactant and the Local Lymph Node Assay as preferred alternative has shown to provide false positive results for surfactants.
- Justification for type of information:
- The analogue approach is used for the hazard assessment of toxicological, eco-toxicological and environmental fate endpoints for the registration Pentamid™ KH (EC 934-047-1). The hypothesis is that data can be read-across between Pentamid™ KH and its structural analogues, based on structural similarity and common breakdown/metabolic products (Scenario 1 of the Read-Across Assessment Framework (RAAF, ECHA, 2015)).
For mammalian toxicity the “parent” substances show no significant systemic or dermal toxicity in mammals and vertebrates. One of the metabolic products of Pentamid™ KH, the well-studied terephthalic acid, has no significant systemic toxicity. The amine metabolite, however, shows diffuse mammalian systemic toxicity at moderate concentrations. This metabolite is employed in the risk assessment, in agreement with the European Union draft Risk Assessment Report of 2008.
The sole classification for Pentamid™ KH is the precautionary aquatic chronic 4 category, based on low water solubility and a log Kow higher than 4.
Read-across data, all evaluated as reliable according to Klimisch scores of 1 or 2, to estimate the toxicity of the registered substance is used for fulfilling the data requirements of the REACH registration and classifying potential hazards. This read-across approach is adequate for the purposes of risk assessment and classification and labeling. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- no data
- Specific details on test material used for the study:
- Clariant Hostagel HT 300 (N-octadecyterephthalamate and 37437-26-6
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- PRELIMINARY irritation study:
intradermal injections:
2%, 5%, 10%, 20%, the highest concentration being the maximum concentration that could technical be injected.
Epidermal application
2%, 5%, 10%, 20%, the highest concentration being the maximum concentration that could technical be applied. Based on the results in the initially treated animals, two additional animals were epidermally treated in a similar manner with 50% at a later stage.
MAIN-Study:
Induction:
- intradermal: test item at 5% concentration
- epidermal: 50% test item concentration
Challenge:
- epidermal: 50% test item concentration - No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- PRELIMINARY irritation study:
intradermal injections:
2%, 5%, 10%, 20%, the highest concentration being the maximum concentration that could technical be injected.
Epidermal application
2%, 5%, 10%, 20%, the highest concentration being the maximum concentration that could technical be applied. Based on the results in the initially treated animals, two additional animals were epidermally treated in a similar manner with 50% at a later stage.
MAIN-Study:
Induction:
- intradermal: test item at 5% concentration
- epidermal: 50% test item concentration
Challenge:
- epidermal: 50% test item concentration - No. of animals per dose:
- 10
- Positive control substance(s):
- yes
- Remarks:
- ALPHA-HEXYLCINNAMICALDEHYDE
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other:
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none observed.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none observed
- Remarks on result:
- other:
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 % . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none observed.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- test item at 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other:
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: test item at 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- test item at 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: test item at 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 20%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 20%. No with. + reactions: 7.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 20%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 20 %. No with. + reactions: 6.0. Total no. in groups: 10.0.
- Interpretation of results:
- other: Not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- There was no evidence that source analogue substance caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in response to a 50% test item concentration in the challenge phase. This result indicates a sensitization rate of 0 per cent. The target substance is not classified for skin sensatisation according to Regulation EC No. 1272/2008.
- Executive summary:
In order to assess the potential of the source test item to induce skin sensitization a Magnusson &
Kligman maximization study in guinea pigs according to OECD 406 guideline was performed.
Test item concentrations selected for the main study were based on the results of a preliminary
study. In the main study, ten experimental animals were intradermally injected with a 5%
concentration and epidermally exposed to a 50% concentration. Five control animals were
similarly treated, but with vehicle alone (corn oil). Approximately 24 hours before the epidermal
induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal
application all animals were epidermally challenged with a 50% test item concentration and the
vehicle. No skin reactions were evident after the challenge exposure in the experimental and
control animals.
There was no evidence that the source substance caused skin hypersensitivity in the guinea
pig, since no responses were observed in the experimental animals in response to a 50% test
item concentration in the challenge phase. This result indicates a sensitisation rate of 0 per cent; the target substance is not classified.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
A close structural analogue to the registered substance was tested in an OECD 406 study and found to be non-sensitsing. The criteria for classification for acute sensitisation according to Regulation EC No. 1272/2008 are not met.
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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