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Diss Factsheets
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EC number: - | 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- In vitro methods not applicable, therefore in vivo was conducted.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reaction mass of Trihydrogen [29H,31H-phthalocyaninetrisulphonato(5-)-N29,N30,N31,N32]cobaltate(3-) and [29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt and dihydrogen [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cobaltate(2-) and hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cobaltate(1-)
- Molecular formula:
- C32H16N8Co(SO3)n with n=0 to 3
- IUPAC Name:
- Reaction mass of Trihydrogen [29H,31H-phthalocyaninetrisulphonato(5-)-N29,N30,N31,N32]cobaltate(3-) and [29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt and dihydrogen [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cobaltate(2-) and hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cobaltate(1-)
Constituent 1
- Specific details on test material used for the study:
- For formulations, the test item was grinded, then freshly diluted with the selected vehicle (DMF. 10% w/v) to obtain appropriate concentrations. The applicable dose levels were based on the results of the Preliminary Irritation/Toxicity Test. Formulations were prepared on weight:volume basis (as % (w/v)). For formulations, the test item was grinded, then freshly diluted with the selected vehicle (DMF. 10% w/v) to obtain appropriate concentrations. The applicable dose levels were based on the results of the Preliminary Irritation/Toxicity Test. Formulations were prepared on weight:volume basis (as % (w/v)).
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 10 weeks old (age-matched, within one week)
- Weight at study initiation: 19.5-21.3 grams (The weight variation in animals involved in the study did not exceed ± 20% of the mean weight.)
- Housing:
- Diet (e.g. ad libitum): ad libidum
- Water (e.g. ad libitum): ad libidum
- Acclimation period: at least 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.0 – 25.5 °C
- Humidity (%): 27 - 83%
- Air changes (per hr): 15-20 air exchanges/hour
- Light :: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 2.5%
5%
10% - No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: Based on the observation of the solubility test, the maximum achievable concentration was 10% (w/v).
- Irritation: There were no indications of any irritancy at the site of application. Clinical
- Systemic toxicity: no mortality or signs of systemic toxicity were observed.
- Ear thickness measurements: Both ears of each mouse were observed for erythema and scored according to OECD Guidelines for Testing of Chemicals No. 429, Table 2. Ear thickness was also measured using a thickness gauge on Day 1 (pre-dose), Day 3 (before treatment, approximately 48 hours after the first dose) and Day 6. Additional quantification of the ear thickness was performed by ear punch weight determination after the euthanasia of the experimental animals.
- Erythema scores: The ear thickness values and ear punch weights were within the acceptable range.
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response:
The test item is regarded as a sensitizer if both of the following criteria are fulfilled:
- That exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than recorded in control mice, as indicated by the stimulation index.
- The data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The positive control substance produces significant lymphoproliferative response increase (SI>3).
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 17.1
- Test group / Remarks:
- Test group 10%
- Key result
- Parameter:
- SI
- Value:
- 14.9
- Test group / Remarks:
- Test group 5%
- Key result
- Parameter:
- SI
- Value:
- 8.9
- Test group / Remarks:
- Test group 2.5%
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Negative control (DMF)
- Parameter:
- SI
- Value:
- 9.3
- Test group / Remarks:
- Positive control
- Cellular proliferation data / Observations:
- Appearance of the lymph nodes were normal in the Control group, slightly larger than normal in the 2.5% (w/v) dose group; larger than normal lymph nodes were observed in the 10 and 5% (w/v) dose group, and in the positive control group.
Any other information on results incl. tables
Since the test item gave a positive response and data permitted, the EC3 value of the test item was calculated (EC3 means the effective chemical concentration required for SI=3). The calculation of the EC3 value was conducted by log-linear interpolation.
The extrapolated EC3 value is 1.3% (w/v).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- In conclusion, under the conditions of the present assay, the test item was shown to have sensitization potential in the Local Lymph Node Assay. The extrapolated EC3 value (that is, the effective chemical concentration required for SI=3) is 1.3% (w/v).
According to Regulation (EC) No 1272/2008 (CLP) and GHS criteria, the test item should be classified in Skin Sensitisation, Category 1 (sub-category 1A) - H317 May cause an allergic skin reaction.
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