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EC number: 278-585-9 | CAS number: 76994-37-1
- 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
Potential sensitisation effects of the test substance to human skin were described in several studies and one case report. Mostly patients with a suspected development of contact dermatitis were patch tested with the test substance. Patients with a known reaction to substances similar to the test substance showed a reaction. From patients with a not further investigated origin of the dermatitis only few developed a reaction after exposure to the test substance. A small study on healthy volunteers showed no reaction after application on the back skin while a reaction was observed on previously stripped skin of the forearm. Therefore the substance might be considered sensitizing in humans prone to allergic skin reactions.
Additional information
Several studies were published and examined in a weight of evidence approach with the results from exposure of human skin.
Bielicky T. and Novak M. (1969) applied the test substance to skin of patients previously found to be reactive toward triphenylmethane. The test substance was applied in a concentration of 2 % in water. A positive reaction was detected in 11 out of 11 patients.
A case report by Shehade S.A. and Foulds I.S. (1986) described a patient that developed eczema after treatment with a gel containing the test substance. After determination of the treatment healing was observed. A following patch test revealed a positive reaction to a concentration of 0.5 and 2 % of the test substance in water on the patient’s skin.
Björnberg A. and Mobacken H. (1972) performed a single dose treatment on healthy back skin of humans. A concentration of 1 % test substance induced no alterations. In addition the forearm skin was stripped and the test substance was applied two times. Here it induced painful superficial ulcerations. Healing of the necrotic tissue occurred after 2-3 weeks leaving hyperpigmentation and scars.
Manzini et al. (1991) established with 20 healthy volunteers that the test substance (concentration of 2 % pet.) was non-irritant on skin. 569 patients that presented with a dermatitis considered to be allergic in origin were patch tested with the same concentration of the test substance. The test was performed on healthy skin on the back of the patients. Two days after application the test substance was removed and the skin area was examined the next day. A positive reaction of the skin was found in only 2 out of 569 patients.
The review from Hatch K.L. and Maibach H.I. (1995) stated that the test substance was found to belong to a group of dyes that induces allergic contact dermatitis in patients. It was found to be an allergen discovered in patients using patch tests.
Conclusion
Taken together, the studies and the case report revealed a possible development of contact dermatitis in humans after exposure to the test substance. A predisposition for reaction to substances with similar properties like the test substance seemed to be necessary for a reaction on healthy skin. In healthy humans a non-irritant concentration (2 %) of the test substance could be established.
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