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EC number: 606-790-9 | CAS number: 215247-95-3
- 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
The test item (Pigment Violet 23) was found to be not a skin sensitiser in the LLNA when tested at up to 30% in acetone:olive oil 4:1 (v/v).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- Remarks:
- performed in accordance with OECD and GLP guidelines
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- according to German Chemikaliengesetzt and OECD Principles of Good Laboratory Practice
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
-strain: CBA/CaOlaHsd
- Source: Harlan Netherlands
- Age at study initiation: 8-12 weeks (beginning of acclimatization)
- Weight at study initiation: 18.3 g to 21.4 g
- Housing: single caging, Makrolon Type I, with wire mesh top, granulated soft wood bedding
- Diet (e.g. ad libitum): Pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): artificial light 6.00 a.m. - 6.00 p.m.
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0 (control), 7.5, 15 and 30% (w/v)
- No. of animals per dose:
- 4 animals per treatment group, 4 animals in the control group
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility:
To determine the highest non-irritant test concentration or the highest technically
applicable concentration, a pretest was performed under RCC-CCR non-GLP study
conditions in two mice. The data showed that the highest test item concentration,
which could be technically used was a 30 % suspension in acetone:olive oil, 4:1 (v/v).
Also in other vehicles used, e.g DMSO, DMF a higher concentrations could not
be suspended.
- Irritation:
At this concentration the treated mouse did not show any toxic symptoms. Due to the colour of
the test item irritation reactions of the ear skin such as redness could not be observed. No
swelling of the ears was observed.
- Lymph node proliferation response: not evaluated
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Pooled (4 animals/group) LLNA
- Criteria used to consider a positive response:
A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an
incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as
indicated by the stimulation index.
- Second, that 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.
TREATMENT PREPARATION AND ADMINISTRATION:
Four female mice were treated with different concentrations of the test item and vehicle alone by topical application at the dorsum of each ear lobe (left and right) on three consecutive days. Five days after the first topical application, the mice were intravenously injected into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Five hours after intravenous injection, the mice were sacrificed and the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a ß-scintillation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- -
- Positive control results:
Test item concentration %(w/v) Group Measurement DPM DPM-BG a) Number of lymph nodes DPM per lymph node b) S.I.
- BG I 0.0 - - - -
- BG II 1.2 - - - -
- CG 1 3855.2 3854.6 8 481.8
5 TG 1 7544.2 7543.6 8 943.0 2.0
10 TG 2 11686.7 11686.1 8 1460.8 3.0
25 TG 3 18946.4 18945.8 8 2368.2 4.9
BG = Background (1 ml 5% trichloroacetic acid) in duplicate
CG = Control Group (Vehicle: acetone:olive oil (4+1))
TG = Test Group
S.I. = Stimulation Index
a) = The mean value was taken from the figures BG I and BG II
b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
EC3 = (a-c) [(3-d)/(b-d)] + c = 9.9%(w/v)- Key result
- Parameter:
- SI
- Value:
- 0.6
- Test group / Remarks:
- 7.5 %
- Key result
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- 15 %
- Key result
- Parameter:
- SI
- Value:
- 0.6
- Test group / Remarks:
- 30 %
- Key result
- Parameter:
- EC3
- Test group / Remarks:
- all
- Remarks on result:
- other: The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No classification
The test item (Pigment Violet 23) was found to be not a skin sensitiser in the LLNA when tested at up to 30% in acetone:olive oil 4:1 (v/v). - Executive summary:
In the study the test item dissolved in acetone:olive oil, 4:l (v/v) was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed using test item concentrations of 7.5, 15, 30 %. The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. In this study Stimulation indices (S.I.) of 0.5, 0.7, and 0.6 were determined with the test item at concentrations of 7.5, 15, 30 %(w/v) in acetone:olive oil, 4:l (v/v). The test item was found to be not a skin sensitiser in this assay.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Endpoint:
- skin sensitisation: in chemico
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
BG = Background (1 ml 5% trichloroacetic acid) in duplicate CG = Control Group TG = Test Group S.I. = Stimulation Index a) = The mean value was taken from the figures BG I and BG II b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/Node was determined by dividing the measured value by the number of lymph nodes pooled The EC3 value could not be calculated, since all SI's are below.
No deaths occurred during the study period. Due to the intense violett colour of the test item local irritation reactions such as ear redness could not be detected. However, no swelling of the ears was observed. Body weights were within the normal range. |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The test item (Pigment Violet 23) was found to be not a skin sensitiser in the LLNA when tested at up to 30% in acetone:olive oil 4:1 (v/v).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Pigment Violet 23 did not show skin sensitising properties in an LLNA according to the current OECD guideline. Allergic skin reactions or case reports of acute contact dermatitis to Pigment Violet 23 have not been described in the literature. Therefore, Pigment Violet 23 does not have to be classified as a skin sensitizer according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
It can reasonably be deduced that Pigment Violet 23 does not cause respiratory tract sensitization and thus does not have to be classified according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC), because
- Pigment Violet 23 did not cause skin sensitization, and
- it is unlikely that Pigment Violet 23 can interact with the immune system due to its extremely low solubility.
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