Registration Dossier
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: 916-899-6 | 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
- Study period:
- June 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- The modification refers to the measurement of cell proliferation by cell counting instead of radioactive labelling. In addition, the acute inflammatory skin reaction is determined to discriminate specific from non-specific activation of immune system
- Principles of method if other than guideline:
- Modified LLNA (IMDS = Integrated Model for the Differentiation of Skin Reactions): The modification refer to the measurement of cell proliferation by cell counting instead of radioactive labelling. In addition, the acute inflammatory skin reaction is determined to discriminate specific from non-specific activation of immun system, as also recommended in the update of OECD TG 429.
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- other: liquid
- Details on test material:
- Dye content: 41.2 %
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6 weeks
- Weight at study initiation: 26-36 g
- Housing: during the study individually
- Diet ad libitum
- Water. ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 0% (vehicle control), 2.5 %, 10 %, 41.2 %, and positve control 30 % alpha hexyl cinnamic aldehyde in DMF
- No. of animals per dose:
- 6
- Details on study design:
- The test item in the formulation, the positive control in the formulation or the vehicle were applied epicutaneousely onto the dorsal part of both ears.of the animals. This treatment was repeated on three consecutive days. The volume administered was 25 µl/ear. The used concentrations were based on the experience with this test system and the properties of the test item.
The animals were anaestetized by inhalation of carbon dioxid and sacrificed one day after the last application. The appropriate organs were then removed. Lymphatic organs (the auricular lymph nodes) were transferred into physiological saline
Investigations:
-weight of lymph nodes
- cell counts in lymph nodes
- stimulation index is calculated by dividing the absolute number of weight or cell count of the subtancetreated lymp nodes by the vehicle treated ones
- ear swelling
- ear weight
-body weight - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- When it was statistically reasonable, the values from treated groups were compared with those from the control group by one-way Analysis of Vartiance (ANOVA) when the variances are considered homogenous according to a homogenicity testig like Cochran's test. Alternatively, if the variances are considered to be heterogenous a non-parametric Kruskal-Wallis test has been used at significance levels of 5 %.. Two sided multiple test procedures were done according to Dunnett or Bonferroni-Holm, respectively. Outlying values in the LN weights were eliminated at a probability level of 99 % by Nalimov's method. In addition, for the LLNA/IMDS the smallest significant differences in the means were calculated by Sheffe's method, wich can be used for both equal and unequal sample sizes.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.02
- Test group / Remarks:
- 2.5% test item
- Remarks on result:
- other: positive level for cell count index is 1.4
- Key result
- Parameter:
- SI
- Value:
- 0.92
- Test group / Remarks:
- 10% test item
- Remarks on result:
- other: positive level for cell count index is 1.4
- Key result
- Parameter:
- SI
- Value:
- 1.18
- Test group / Remarks:
- 41.2% test item
- Remarks on result:
- other: positive level for cell count index is 1.4
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: modified LLNA; measurement of cell counts instead of radioactive labelling.
Any other information on results incl. tables
It has to be clarified that the positive levels are exclusively difined for the NMRI mice used for this study:
The positive level of ear swelllling which is 2x10 [exp -2] mm increase , i.e. about 10 % of the control values, has not been reached or exceeded in any dose groups of the test item whereas the respective value of the positive control has shown a statistical significant increase.
body weights of the animals was not affected by any treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- A LLNA/IMDS was carried out in female NMRI mice after epicutaneous application of formulation containing 0%, 2.5 %, 10 %, or 41.2 % of the test item Bayscript Blaukomponenten in DMF for 3 consecutive days onto both ears of the animals. The study was conducted according to OECD TG No. 429 and No 406. Bayscript Blaukomponente showed no sensitizing potential in the modified Local Lymph Node Assay (IMDS) in female NMRI mice after dermal application of up to and including a 41.2 % concentration. Additionally, no indication for a non-specific(irritant) activation by the test item was detected. The positive control hexyl cinnamic aldehyde (CAS-No. 101 -86 -0) was functional for each parameter (Vohr 2012). According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
- Executive summary:
A LLNA/IMDS was carried out in female NMRI mice after epicutaneous application of formulation containing 0%, 2.5 %, 10 %, or 41.2 % of the test item Bayscript Blaukomponenten in DMF for 3 consecutive days onto both ears of the animals. The study was conducted according to OECD TG No. 429 and No 406. Bayscript Blaukomponente showed no sensitizing potential in the modified Local Lymph Node Assay (IMDS) in female NMRI mice after dermal application of up to and including a 41.2 % concentration. Additionally, no indication for a non-specific(irritant) activation by the test item was detected. The positive control hexyl cinnamic aldehyde (CAS-No. 101 -86 -0) was functional for each parameter (Vohr 2012). According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
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.

Route: .live2