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EC number: 801-694-5 | CAS number: 1392325-86-8
- 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 sensitisation: skin sensitiser (1B) based on testing in OECD TG 429.
Respiratory sensitisation: the substance is not a respiratory sensitiser
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
LLNA
The substance was tested in an LLNA test (OECD TG 429) at concentrations of 10%, 25% and 50%. Positive and negative controls were included to confirm the validity of the test. In a range finding test, no signs of systemic toxicity or excessive irritation indicated by an equal to or greater than 25% increase in mean ear thickness were noted. Very slight erythema was noted on both ears on days 3 and 4. Based on this information the dose levels for the main test were selected (10%, 25% and 50% w/w in acetone/olive oil 4:1). In the main test, no mortality occurred and no signs of systemic toxicity were noted in the test animals during the test. SI values were 1.66, 5.34 and 7.56 for the 10%, 25% and 50% test group, respectively. An EC3 value of 15% was calculated. The NOEC is considered to be 10%. Based on these results, the substance is a skin sensitiser (1B).
HRIPT
In addition to the LLNA test two HRIPT studies with the substance were performed. The substance was tested in 104 and 106 subjects, using concentrations of 5% and 10%, respectively. No dermal reactions were seen. This information is not used for further assessment.
HRIPT (5%)
The induction phase took place on Monday, Wednesday and Friday till 9 applications had been made in approximately 3 weeks. The amount of volume applied was 0.2 ml, test concentration used was 5% and the applied surface was 3.63 cm^2.
During the induction patches were placed at the upper side of the back. Technicians removed the patches 24 hours after application, except for Saturdays on which the patients removed the patches themselves. After removal, 24 hours the skin was not treated, except for the 48 hours treatment free period after the Friday application. Two weeks after the final induction treatment, a challenge patch was applied to untreated sites of the back and removed after 24 hours. Reactions to the challenge were assessed after 24, 48, 72 and 96 hours. None of the 104 subjects tested was sensitised by the sample. It was therefore concluded that the test substance is not sensitising at the concentration used. This result can be compared to LLNA results as the application equals 200 mg*0.05/3.63 = 2.75mg (2750 µg)/cm^2.
HRIPT (10%)
The induction phase took place on Monday, Wednesday and Friday till 9 applications had been made in approximately 3 weeks. The amount of volume applied was 0.2 ml, test concentration used was 10% and the applied surface was 3.63 cm^2.
During the induction patches were placed at the upper side of the back. Technicians removed the patches 24 hours after application, except for Saturdays on which the patients removed the patches themselves. After removal, 24 hours the skin was not treated, except for the 48 hours treatment free period after the Friday application. Two weeks after the final induction treatment, a challenge patch was applied to untreated sites of the back and removed after 24 hours. Reactions to the challenge were assessed after 24, 48, 72 and 96 hours. None of the 106 subjects tested was sensitised by the sample. It was therefore concluded that the test substance is not sensitising at the concentration used. This result can be compared to LLNA results as the application equals 200 mg*0.1/3.63 = 5.5mg (5500 µg)/cm^2.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The substance is not a respiratory sensitiser in absence of human data indicating such effects. In addition, the respiratory sensitisation is assessed using the integrated evaluation strategy for respiratory sensitisation data in the ECHA guidance (R7A, Fig. 7.3-4, 2017).
1) The substance is a skin sensitiser;
2) The substance does not belong to the di-isocyanates;
3) the substance has no structural alerts or is structurally related to chemicals causing respiratory sensitisation as presented in Table R.7.3-1 in the ECHA guidance of 2008 or those provided in the following document: http://ec.europa.eu/health/scientific_committees/docs/annex6_respiratory.pdf. Therefore, the substance is not considered to be a respiratory sensitiser.
Justification for classification or non-classification
The substance has to be classified as skin sensitisation category 1B and shall be labelled with H317: May cause an allergic skin reaction according to EU CLP (EC no. 1272/2008 and its amendments).
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