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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 944-562-3 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- The test was conducted by means of Read Across approach. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- .
- GLP compliance:
- no
Test material
- Reference substance name:
- Acid Black 071:1 - Similar Substance 02
- IUPAC Name:
- Acid Black 071:1 - Similar Substance 02
- Test material form:
- not specified
1
Test animals
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or test system and environmental conditions:
- Housing period: > 3 days
light and dark cycle: 12 hours of light/12 hours of darkness from 7 to 19
Temperature: 22 +/- 1°C
Relative humidity: 55 +/- 10%
cages: stainless steel without bedding
number of animals per cage: 1
number of animals per group: 6
Feed: standard pellets for rabbits
Feed and drink: ad libitum
Distribution of animals per group: randomly
body weight: 3 to 4 kg
Test system
- Controls:
- other: negative control is the untreated skin area
- Amount / concentration applied:
- Volume of applications: 0.5 ml for liquids
0.5 g for solid substances (possibly as a 50 %-ground) - Duration of treatment / exposure:
- 24h
- Observation period:
- after 24 and 72h, at 72h after diagnosis-. last raeding at 7 days
- Details on study design:
- shearing of the skin: at least before 2hours prior application but no more than 16 h in advance
scarification of the skin: always left side with the reverse scalpel-sharp on an area of 6.25 cm2 with 5 orthogonal painted immediately before application
number of application: 1
application site: upper third of the back of the caudal ribs right: intact skin
on the left: scarified skin
ared of the application site: 2.5 x 2.5 cm
the application site is closed with gause and plastic band and wrappted with PVC film. At the end of exposure the skin is washed with warm water with Lutrol 400
Results and discussion
In vivo
Results
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- other: mean 24, 48 and 72h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: the value at 48h was not determined experimentally and the worst case between 24 and 72h is used
- Irritant / corrosive response data:
- no erythema was assessed due to skin discolouration
- Other effects:
- 24 h after application of the test substance on 2 rabbits with scarified skin the application area was slightly hardened. 7 days after application, a slight sloughing of the scarified area was noted in 1 rabbit.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- The substance was tested for skin irritation potential. Under the experimental conditions no skin irration was osberved.
- Executive summary:
Method
The substance was tested for skin irritation potential. Albino rabbits were tested on intact and scarified skin with patch test of the substance and observed at 24h, 72h and 7 days after applcation. Edema was scored while erythema was not possible due to skin discolouration. The value at 48h is missing and the worst case bewteen 24 and 72h was used for the calculation of the mean figure.
Results
Under the experimental conditions the substance is not considered a skin irritant.
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.