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EC number: 692-721-8 | CAS number: 757251-39-1
- 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
AFP-Picolinmethylamid revealed neither corrosive nor irritant properties in a human 3D-Skin model as well as no irritant properties in a human 3D-Cornea model.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Mar 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Principles of method if other than guideline:
- The HCE model is currently involved in the eye irritation validation conducted by COLIPA following ECVAM guidelines. Furthermore, it is routinely used by the major Cosmetic and Pharmaceutical companies, and has already been prevalidated in 2004 (van Goethem et. al., Tox in Vitro 20, 2006, 1-17). This model is recognized as the model of choice and scientifically relevant as documented by several publications (Cotovio et. al., Tox in Vitro, 24, 2010, 523-537).
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: human corneal epithelium (HCE)
- Strain:
- other: not applicable
- Vehicle:
- other: test item moistened with phosphate buffered saline (PBS, 30 µl)
- Controls:
- other: negative control: phosphate buffered saline (PBS, 30 µl); positive control: 3-Mercapto-1,2,4-triazole (30 mg, plus 30 µl PBS for moistening)
- Amount / concentration applied:
- 30 mg per insert
- Duration of treatment / exposure:
- 60 minutes
- Observation period (in vivo):
- post-exposure incubation: 16 hours
- Details on study design:
- The irritation potential of the test item is assessed by determination of its cytotoxic effect on an reconstituted human ocular epithelia. The test principle is based on the MTT assay reflecting the cell viability after exposure of the cornea equivalent to topically applied test item.
Tests were performed in triplicates. The test item was applied at a 100 % concentration, i.e. 30 mg per insert (plus 30 µl PBS to moisten and ensure good contact to the tissue), for 60 min at room temperature. After the exposure period the inserts were washed carefully with PBS. After a post-exposure incubation of 16 hours in the incubator (37 +/- 2 °C, 5 % CO2, maximum humidity) MTT reduction was performed. Cell viability was measured by the amount of MTT reduction, i.e. an OD value following exposure to the negative or positive control substances or the test item. - Interpretation of results:
- other: no irritant property
- Executive summary:
An in vitro study for assessing ocular irritation was conducted on a human corneal epithelial (HCE) cell model. This model is routinely used by the major Cosmetic and Pharmaceutical companies and has already been prevalidated in 2004 (van Goethem et. al. (2006), Tox in Vitro 20, 1-17). Undiluted AFP-Picolinmethylamid was applied topically to the reconstituted HCE tissue (30 mg per insert plus 30 µl PBS to moisten and ensure good contact to the tissue). After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was 107.60 % as measured by a MTT conversion assay. As the cut-off for a non-irritant to the eye is 50 % (a test substance is predicted to be an ocular irritant if the relative tissue viability (%) exposed to the test substance is < 50 %), AFP-Picolinmethylamid was considered to be non-irritant to the eye.
Reference
Table 1: Summary of results from HCE test with AFP-Picolinmethylamid
Compound |
Cell viability [%] |
Evaluation |
Negative control |
100.00 |
non-irritant |
Positive control |
9.57 |
irritant |
AFP-Picolinmethylamid |
107.60 |
non-irritant |
The test item was detected as non-irritant in this test model.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In two in vitro tests using an artificial 3D-Skin model AFP-Picolinmethylamid revealed neither corrosive (OECD TG 431; Leidenfrost, 2014a) nor irritant properties (OECD TG 439; Leidenfrost, 2014b).
Eye irritation
AFP-Picolinmethylamid was identified as non-irritant to human corneal epithelial cells (cell viability = 107.60 %) in the in vitro HCE test
(Wingenroth, 2014).
Justification for selection of skin irritation / corrosion endpoint:
No study was selected, since both in vitro studies with AFP-Picolinmethylamid revealed no adverse effects in a skin model.
Justification for selection of eye irritation endpoint:
Only one study available
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not required.
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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