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EC number: 203-404-7 | CAS number: 106-50-3
- 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
Sensitizing in mouse LLNA (multiple studies similar to OECD 429); EC3 =
0.11%
Reports of sensitisation reactions in humans have been reported in the
literature (refer to IUCLID 5 for additional details).
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
LLNA assay
The test substance induced a positive response in the local lymph node assay, as there was at least a 3-fold increase in isotope incorporation in the draining auricular lymph node relative to the vehicle, with a calculated value of 0.06%. The mean stimulation indices were 2.6, 10.4, and 16.1 at concentrations of 0.05, 0.25, and 1.25%, respectively. Numerous reports of sensitisation reactions in humans have been reported in the literature (refer to IUCLID 5 for additional details).
Weight of Evidence approach
From the available publications(Goebel et al., 2012; Warbrick et al., 1999; White et al., 2006) and the LLNA results (MDS Pharma, 2003) it is evident that there is a steep dose-response in SI between 0.05 and 0.25%. Therefore, it is considered more appropriate to use the available studies in a weight of evidence approach, thus increasing the statistical power.
Basketter and colleagues have reviewed thecollation of EC3 data from repeat testing in multiple laboratories the utility and validity of these relative potency measurements including the LLNA(Basketter et al., 2007). A total of 10 EC3 values for the substance were collected from the literature, 8 of which collected once a month over a 4 month period in 1998 and two collected in 2005.The concerning studies were conducted similar to OECD TG 429 without obvious deviations.The EC3 values ranged from 0.06 to 0.18, and the authors calculated a mean EC3 of 0.11± 0.014 %.Considering the statistical power resulting from the large number of available EC3 values (10) and the relatively small range of the reported EC3 values (0.06-0.18) (despite the steep dose-response), the averaged EC3 of 0.11% is regarded the most appropriate value reflecting the relative skin sensitizing potency of the substance.
References
Basketter DA, Gerberick F, Kimber I. The local lymph node assay and the assessment of relative potency: status of validation. Contact Dermatitis. 2007 Aug;57(2):70-5.
Goebel C, Diepgen TL, Krasteva M, Schlatter H, Nicolas JF, Blömeke B, Coenraads PJ, Schnuch A, Taylor JS, Pungier J, Fautz R, Fuchs A, Schuh W, Gerberick GF, Kimber I. Quantitative risk assessment for skin sensitisation: consideration of a simplified approach for hair dye ingredients. Regul Toxicol Pharmacol. 2012 Dec;64(3):459-65. doi: 10.1016/j.yrtph.2012.10.004. Epub 2012 Oct 13.
Warbrick EV, Dearman RJ, Basketter DA, Kimber I. Local lymph node assay responses to paraphenylenediamine: intra- and inter-laboratory evaluations. J Appl Toxicol. 1999 Jul-Aug;19(4):255-60.
White, J.M., Kullavanijaya, P., Duangdeeden, I., Zazzeroni, R., Gilmour, N.J., Basketter, D.A., McFadden, J.P., 2006. p-Phenylenediamine allergy: the role of Bandrowski’s base. Clin. Exp. Allergy 36, 1289–1293.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
There was no evidence of respiratory sensitisation during inhalation exposure.
Justification for classification or non-classification
The test substance produced skin sensitisation in laboratory animals, but there was no evidence of respiratory sensitisation during inhalation exposures. The substance should be classified as R43: May cause sensitisation by skin contact according the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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