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EC number: 278-133-0 | CAS number: 75214-65-2
- 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
Skin sensitiser based on results of GPMT.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From July 27th to August 29th, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- Details on the read-across are available in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted July 17, 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Experiment already available.
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRl, Biological Research laboratories ltd. Wölferstrasse 4, 4414 Füllinsdorf/Switzerland.
- Age at study initiation: 5 - 7 weeks.
- Weight at study initiation: 336 - 391 g.
- Housing: individually in Makrolon type-3 cages with autoclaved standard softwood bedding.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: 1 week.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 24 °C
- Humidit:: 52 - 74 %
- Air changes: 10-15 per hr
- Photoperiod: 12 hrs dark / 12 hrs ligh - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5 %
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25 %
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25 %
- Day(s)/duration:
- 1
- No. of animals per dose:
- Control: 5 animals
Treated: 10 animals - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal, 1 epidermal.
- Exposure period: 8 days.
- Test groups: 10 animals
- Control group: 5 animals
- Site: scapular area.
- Frequency of applications: 2 at a weeks distance.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Site: flank
- Concentrations: 25 %
- Evaluation: 24 and 48 hr after challenge. - Challenge controls:
- Opposite flank
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- no
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- no
- Group:
- positive control
- Remarks on result:
- other: no data available
- Interpretation of results:
- other: Skin Sens 1B, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Test item caused skin reactions after challenge in all treated animals
- Executive summary:
To assess the allergenic potential of test item in albino guinea pigs, the Maximization-Test of B. Magnusson and A.M. Kligman (1969) was used.
Five males were used as control group and 10 males were used as test group.
The highest non-irritating test article concentration used for challenge application was 25 % in bi-distilled water.
All treated animals of test group showed erythematous skin reactions 24 and 48 hours after epidermal challenge exposure and test material is judged skin sensitising.
Conclusion
Skin sensitizer; more than 30 % responding at an intradermal induction dose higher than 1 %.
Reference
Test Group Skin Response after challenge test article-treated, 25 % in distilled water
Animal | Sex | erythema (24 h) | edema (24 h) | erythema (48 h) | edema (48 h) |
11 | male | 1 | 0 | 1 | 0 |
12 | male | 1 | 0 | 1 | 0 |
13 | male | 2 | 0 | 3 | 0 |
14 | male | 2 | 0 | 2 | 0 |
15 | male | 3 | 0 | 2 | 0 |
16 | male | 1 | 0 | 2 | 0 |
17 | male | 2 | 0 | 2 | 0 |
18 | male | 2 | 0 | 3 | 0 |
19 | male | 2 | 0 | 1 | 0 |
20 | male | 1 | 0 | 1 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
There are no information about the skin sensitisation potential of Acid Black 222, thus available information on the structural analogue Similar Substance 01 have been taken into consideration; the read across approach can be considered as appropriate and suitable to assess the property under investigation. Details are available in section 13.
Similar Substance 01 was tested for skin sensitisation potential in a Guinea Pigs the Maximization-Test, outlined by Magnusson and Kligman (1969). The highest non-irritating test article concentration used for challenge application was 25 % in bi-distilled water. All treated animals of the test group showed erythematous skin reactions 24 and 48 hours after epidermal challenge exposure and test substance was judged skin sensitising. More than 30 % animals showed reactions responding to an intradermal induction dose higher than 1 %.
Similar outcomes were obtained in a second GPMT performed on Similar Substance 01. Under the experimental conditions, 80 % and 90 % of animals of test group showed skin reactions 24 and 48 hours, respectively, responding to intradermal induction dose higher than 1 %.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the CLP Regulation (EC) No 1272/2008, 3.4.2.2 skin sensitisation section, skin sensitizer means a substance that will lead to an allergic response following skin contact. Effects seen in either humans or animals will normally justify classification in a weight of evidence approach for skin sensitizers.
In the experiments performed on an analogue, more than 30 % of animals showed reactions responding to an intradermal induction dose higher than 1 %; thus, a classification as skin sensitizer, category 1B (i.e. Skin Sens. 1B, H317) of the CLP Regulation (EC) No 1272/2008, is applied to Acid Black 222.
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.
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