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Diss Factsheets
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EC number: 252-772-5 | CAS number: 35869-64-8
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test preparation is a composite of two pigments, the exact dose of the test substance is not known.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- To determine if the test material is capable of irritating the skin of humans under controlled test conditions; and, if so, to classify the test material as a primary irritant, fatiguing agent, and/or sensitizer on the basis of visible clinical responses, the test material was applied under occlusion for a series of effective contact periods of two days duration. The patches were then removed, the contact sites examined, and the reactions, if any, were graded and recorded. The following scoring, system was used to grade skin reactions: 0 = No reactions; 1+ = Slight erythema; 2+ = Marked erythema; 3+ = Marked erythema, edema, with or without a few vesicles; 4+ = Marked erythema, edema, with vesicles and oozing. If no reactions occurred, the test material was re-applied immediately for another forty-eight-hour period, and the cycle repeated for 3 more weeks, so that a series of 8 48-hour applications were completed. A challenge was then performed 2 week later and the skin reaction examined 24 and 48 hours thereafter.
- GLP compliance:
- no
Test material
- Reference substance name:
- Bis(2-chloroethyl) 3,3'-[(2,5-dimethyl-p-phenylene)bis[iminocarbonyl(2-hydroxy-1,3-naphthylene)azo]]di-p-toluate
- EC Number:
- 269-507-4
- EC Name:
- Bis(2-chloroethyl) 3,3'-[(2,5-dimethyl-p-phenylene)bis[iminocarbonyl(2-hydroxy-1,3-naphthylene)azo]]di-p-toluate
- Cas Number:
- 68259-05-2
- Molecular formula:
- C50 H42 Cl2 N6 O8
- IUPAC Name:
- 2-chloroethyl 2-[(2Z)-2-[3-[[4-[[(4E)-4-[[5-(2-chloroethoxycarbonyl)-2-methylphenyl]hydrazinylidene]-3-oxonaphthalene-2-carbonyl]amino]-2,5-dimethylphenyl]carbamoyl]-2-oxonaphthalen-1-ylidene]hydrazinyl]-3-methylbenzoate
- Details on test material:
- No details provided
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 200
- Clinical history:
- A group of 200 individuals who qualified were selected from a local population. The criteria for qualifying were:
1. General well-being.
2. Absence of any skin disease which might be confused with skin reactions from the test material.
3. Willingness to cooperate.
4. Dependability and intelligence in following directions.
5. Reading, understanding, and signing an informed-consent contract (in the case of minors, parental consent was obtained). - Controls:
- Untreated skin sites
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
A. INDUCTION EXPOSURE
- No. of exposures: 8
- Exposure period: 48 hours per exposure
- Test groups: 20% test substance in a composite
- Site: 3 cm x 3 cm
- Frequency of applications: twice a week
- Duration: 4 weeks (patch on Mondays, scoring following by a new patch on Wednesdays, scoring on Fridays following by resting until the following Monday, when the procedure is repeated). New patches were applied only if no reactions occurred and the volunteers were instructed to call in case of any discomfort.
B. CHALLENGE EXPOSURE
- No. of exposures: once
- Day(s) of challenge: at least 2 weeks after the last induction
- Exposure period: 48 hours
- Test groups: 20% test substance in a composite
- Site: same as induction
- Evaluation (hr after challenge): 0, 24 and 48 hours after challenge
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 200
Any other information on results incl. tables
- 1). Skin changes accompanying application No. 1: no visible skin changes signifying reaction to injury were observed in any of the 200 subjects.
- 2). Skin changes accompanying application Nos. 2 through 8: visible skin changes signifying reaction to injury were observed in 1 out of 200 subjects.
- 3). Skin changes accompanying challenge Application: no visible skin changes signifying reaction to injury were observed in any of the 200 subjects.
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.