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EC number: 228-819-0 | CAS number: 6359-98-4
- 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:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Repeated Insult Patch Test
- GLP compliance:
- no
Test material
- Reference substance name:
- Acid Yellow 017
- IUPAC Name:
- Acid Yellow 017
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- 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 cf the visible clinical responses.
A group of 200 individuals who qualified were selected from a local population.
All of these individuals volunteered to participate in this evaluation. 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). - Route of administration:
- dermal
- Details on study design:
- The test materials were applied under occlusion for a series of effective contact periods of two days' duration, i.e. Monday to Wednesday, and Wednesday to Friday of each week for four weeks. On Mondays, the test materials were applied. On Wednesdays, the patches were removed, the contact sites examined, and the test materials re-applied for another 48-hour period. On Fridays, the covers were removed and the contact sites were again examined and graded. The contact sites were then rested until the following Monday.
A mixture of the group of four materials was applied to a single predesignated contact site which was reserved for this specific group throughout the test.
On each application day, 4 % aqueous solutions were freshly made. 50 ml of the solutions of each of the four test materials comprising each group were then mixed together and 1 ml was pipetted off to saturate a lintine disc, 1.25 inch in diameter. One such disc was placed intimately in contact with the contact site on each participant and covered with a water-impermeable sheet of plastic (1.5 inch by 1.5 inch). The plastic was then affixed to the skin with Blenderrn tape applied in such a manner as to seal the edges and maintain the integrity of the micro-climate under the patch.
On the second Monday following the removal of the last series of applications, each contact site was challenged with its corresponding composite of test materials. The covers were removed on Wednesday, thereby effecting a challenge contact period of 48 hours' duration. The contact sites were examined for visible changes which, if present, were graded and recorded. Sites were re-examined 24 and 48 hours later for delayed reactions.
Composites which elicited reactions during the test were separated into individual components for re-challenge on reacting individuals. Results of these re-challenge applications are appended.
At all reading periods, it was found useful to wash the sites in order to remove the dyestuffs obscuring the underlying skin, Mild, gentle sponging with warm water was found to be satisfactory.
Results and discussion
- Results of examinations:
- Visible skin changes signifying reaction to injury were observed in 2 out of 200 subjects during the series of application or following the challenge application.
On re-challenge, the component found to be responsible was one of the tested components, other than test item.
Despite the reactions elicited by the composite and/ or the components contained therein, it is the opinion of the investigator that the results must be interpreted as indicative of having potential rather than obligatory irritating capabilities because of the unusual conditions of the test.
Applicant's summary and conclusion
- Conclusions:
- Non skin-sensitising under tested conditions.
- Executive summary:
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 cf the visible clinical responses. A group of 200 individuals who qualified were selected from a local population. A mixture of the group of four materials was applied to a single predesignated contact site which was reserved for this specific group throughout the test. On each application day, 4 % aqueous solutions were freshly made. The covers were removed on Wednesday, thereby effecting a challenge contact period of 48 hours' duration. The contact sites were examined for visible changes which, if present, were graded and recorded. Sites were re-examined 24 and 48 hours later for delayed reactions. Composites which elicited reactions during the test were separated into individual components for re-challenge on reacting individuals.
Visible skin changes signifying reaction to injury were observed in 2 out of 200 subjects during the series of application or following the challenge application. On re-challenge, the component found to be responsible was one of the tested components, other than test item. Despite the reactions elicited by the composite and/ or the components contained therein, it is the opinion of the investigator that the results must be interpreted as indicative of having potential rather than obligatory irritating capabilities because of the unusual conditions of the test.
Conclusion
Non skin-sensitising under tested conditions.
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