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EC number: 276-067-7 | CAS number: 71839-81-1
- 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
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Stabdard Guideline study under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Savinyl Orange RLS
- IUPAC Name:
- Savinyl Orange RLS
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands; BV Postbus 6174; NL- 5960 AD Horst/ The Netherlands
- Age at study initiation: 8- 12 weeks
- Weight at study initiation: 17,7 g
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- 5.0, 10.0, and 25.0 % (w/v)
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Irritation: inhibited by intense color of test item
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- 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 - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The positiv control substance produced a SI value of 3,0 at 10 %.
In vivo (LLNA)
Results
- Key result
- Parameter:
- SI
- Value:
- > 1.5 - < 2.1
- Variability:
- Values of 1.5 to 2.1 were determined at concentrations of 5 to 25 %
- Remarks on result:
- other: See table below
Any other information on results incl. tables
Test item concentration % (w/v) | Group | Measurement | Calculation | Result | ||
DPM | DPM-BG a) | DPM per Lymph node | Lymph nodes | S.I. | ||
--- | BG I | 20,3 | --- |
--- |
--- |
--- |
--- | BG II | 0.0 | ||||
--- | CG 1 | 2653.1 | 2643.0 | 330.4 | 8 | |
5.0 | TG2 | 3982.2 | 3972.1 | 496,5 | 8 | 1.5 |
10.0 | TG 3 | 5534.8 | 5524.7 | 690.6 | 8 | 2.1 |
25.0 | TG4 | 5385.4 | 5375.3 | 671.9 | 8 | 2.0 |
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
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was not a skin sensitiser under the conditions of this LLNA in female mice.
- Executive summary:
In the study the test item dissolved in methyl ethyl ketone was assessed for its possible contact allergenic potential.
For this purpose a local lymph node assay was performed in female CBA mice using test item concentrations of 5.0, 10.0, and 25.0%.
The animals did not show any clinical signs during the course of the study and no cases of mortality observed.
In this study Stimulation Indices (S.L) of 1.5, 2.1 and 2.0 were determined with the test item at concentrations of 5 0, 1 0.0, and 25 .. 0% (w/v) in methyl ethyl ketone, respectively.
Thus, the test item Savinyl Orange RLS was not a skin sensitiser.
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