Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 947-892-6 | CAS number: -
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Maximisation test was done by first applying an irritant to the skin of volunteers. This was followed by an induction phase with the test substance applied at two locations to the volunteers for 48 hours, followed by either a repeat application of the irritant for 24 hours or a rest period of 24 hours. This was repeated up to a total of five induction administrations. Eleven days later, a challenge test was done by administering the test substance to one of the two induced locations.
- GLP compliance:
- no
Test material
- Reference substance name:
- Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts
- EC Number:
- 307-259-1
- EC Name:
- Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts
- Cas Number:
- 97592-62-6
- Molecular formula:
- not available
- IUPAC Name:
- Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Name as used in the study report: MA-78 = compound 4204
Method
- Type of population:
- general
- Ethical approval:
- other: Study approved by institutional review board of the test facility; informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 32; 30 completed the study
- Sex: male and female
- Age: 15-78
- Race: not designated
- Inclusion criteria: Twelve (12) years of age or older. Free of significant systemic or dermatologic disorder. Completing preliminary medical form. Reading, understanding and signing an informed consent.
- Exclusion criteria: Any visible skin disease at the test site which might interfere with the evaluation. Individuals taking medication which in the opinion of the investigators would interfere with the test results. Individuals with atopic dermatitis - Clinical history:
- - No visible skin disease at test site which might interfere with the evaluation
- No medication which would interfere with the test results
- No atopic dermatitis - Controls:
- One induced location at each volunteer acted as internal control
- Route of administration:
- dermal
- Details on study design:
- INDUCTION
The test was initiated with the application of 0.2 ml of 2.5% aqueous sodium lauryl sulfate to duplicate sites on the subjects back. Twenty-four hours later both patches were removed and evaluated. Following evaluation, a patch containing 0.1 ml of test material was applied to one site, while the other (control) was covered with a non-treated patch. Forty-eight hours later both patches were removed and the sites graded. Those sites with at least a 1+ reaction were "allowed to rest" for 24 hours. If no erythema (1+ or more) was present, the sites were again covered with SLS patches for twenty-four hours. This procedure of alternating 24 hour sodium lauryl sulfate (or rest period if 1+ reaction was present) and 48 hours test material patches was continued for a total of five applications of the test material. On Thursday of week 3, a final evaluation of the test sites was made. The panelists were dismissed for an eleven day rest period with instructions to avoid irritating the test sites throughout the recess and to notify the investigator immediately if any adverse changes were observed.
CHALLENGE
On Monday of week 5, occlusive patches containing approximately 0.2 ml. of 5.0% aqueous sodium lauryl sulfate were applied to duplicate sites. After a period of one hour, the patches were removed. As in the induction phase, one site was then covered with an untreated occlusive patch, while the other received a patch containing 0.1 ml of test material. Forty-eight hours later the patches were removed, the area wiped with a tissue and the sites graded at twenty-four hour intervals, i.e., 48, 72 and 96 hours after application. The reactions were graded on a five point scale from - = no reaction to ++++ = vesticular reaction. A grade of ++ (erythema with edema) at the challenged site, without a similar reaction at the control site, was considered to be a sign of sensitisation.
Results and discussion
- Results of examinations:
- During the challenge phase, one individual showed a + reaction 96 hours after patch application of test material (48 hours after removal of patch). This reaction represents irritancy since (1) the SLS control site had a similar + reaction and (2) a reaction of ++ or greater is generally needed to establish sensitization. Eight subjects had reactions graded as ++ or +++ on the SLS control sites at some time during the induction phase. These reactions had minimal edema and did not spread beyond the site of application. Thus, these scores represent irritant reactions, which was the purpose for using SLS. Similar reactions were seen during induction at product test sites in eight individuals. These were also interpreted as irritant reactions.
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.