Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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: 272-745-1 | CAS number: 68910-55-4
- 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
This study was based on Guideline 429, Skin Sensitization: Local Lymph Node Assay, the OECD Guideline for Testing of Chemicals, revised July 2010. Organolignite was determined to not be a sensitizer when tested at concentrations of 15%, 30% or 61%, the highest achievable concentration (solvent used was Dimethyl Sulphoxide), in the Murine Local Lymph Node Assay. No adverse effects were observed during the course of this study.
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
- Study period:
- 2013-07-08 to 2013-07-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- A protocol deviation was noted because lymph node samples were centrifuged at 1-6 degrees C instead of 4 degrees C. The Study Director commented that this deviation did not affect the quality or integrity of the study.
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: The Jackson Laboratory, Bar Harbor, Maine, USA
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 18-23.5 grams
- Housing: Upon arrival, the animals were housed in groups of 4 in suspended, stainless steel, wire mesh cages to allow time to adapt to the automatic
watering system. For the study, animals were individually housed in the same type of caging.
- Diet (e.g., ad libitum): Block Lab Diet® (Certified Rodent Diet #5002, PMI Nutrition International, Inc.) was available ad libitum.
- Water (e.g., ad libitum): Tap water was available ad libitum via an automatic watering system.
- Acclimation period: 6-8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 °C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hrs of light and dark - Vehicle:
- dimethyl sulphoxide
- Concentration:
- Treated groups were administered the test article at 15%, 30%, or 61% (maximum achievable dose in vehicle).
- No. of animals per dose:
- Five
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: DMSO was determined to be the most effective vehicle for the test article, organolignite.
- Irritation: The test article, organolignite, was administered once on Day 1 via dermal application to the surface of both ears using a 1 mL syringe.
The test article was administered at dose concentrations of 4, 8, 15, 30, or 61% at a dose volume of 25 µL/ear. The formulations were stirred
continuously throughout dosing using a magnetic stir bar and stir plate. On Day 6, surviving Phase 1 animals were euthanized.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD Guideline 429, Skin Sensitization: Local Lymph Node Assay.
- Criteria used to consider a positive response: A sensitization index equal to or greater than 3.0.
TREATMENT PREPARATION AND ADMINISTRATION: The test article vehicle, dimethyl sulphoxide (DMSO); the vehicle for the positive control,
Acetone/Olive Oil (4:1 v/v); the positive control, α Hexylcinnamaldehyde (HCA); or the test article, organolignite; were administered daily for three
consecutive days (Days 1 to 3) via dermal application to the surface of both ears at approximately the same time each day (±1 hour) using a 1 mL
syringe. The treated groups were administered the test article at dose concentrations of 15%, 30%, or 61%, and the positive control article was
administered as a 35% solution of HCA in vehicle. Both treated and control groups were administered the vehicle, positive control, or test article at a dose volume of 25 µL/ear. On Day 6, the cell proliferation marker article, [3H] methyl thymidine, was administered to all groups via bolus intravenous injection via the tail vein at a target dose level of 20 µCi/animal and a target dose volume of 0.25 mL/animal. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Body Weights: Analyzed by Group Pair-wise Comparisons (Levene’s/ANOVA Dunnett’s/Welch’s)
Disintegrations per minute (DPM): Analyzed by Log Transformation/Group Pair-wise Comparisons
Group Pair-Wise Comparisons (Levene’s/ANOVA-Dunnett’s/Welch’s):
If sample sizes for all groups were three or greater, Levene’s test was used to assess homogeneity of group variances for each specified endpoint
and for all collection intervals. If Levene’s test was not significant (p>=0.01), a pooled estimate of the variance (Mean Square Error or MSE) was
computed from a one-way analysis of variance (ANOVA) and utilized by a Dunnett’s comparison of each treatment group with the control group. If
Levene’s test was significant (p<0.01), comparisons with the control group were made using Welch’s t-test with a Bonferroni correction. Results of all pair-wise comparisons are reported at the 0.05 and 0.01 significance levels. All endpoints were analyzed using two-tailed tests.
Log Transformation/Group Pair-wise Comparisons:
Historical data indicate that DPMs are not normally distributed; therefore, a log transformation was performed on these data. The transformed data
were analyzed as described in the Group Pair-wise Comparisons section. - Positive control results:
- In the LLNA, the positive control group (35% HCA) resulted in a sensitization index (SI) of 5.33, which is indicative of a sensitizer (SI ≥3).
In addition, the SI correlated well with the mean dpm values, which were significantly increased in the 35% HCA group relative to the vehicle group. - Parameter:
- SI
- Value:
- 0.92
- Test group / Remarks:
- 15% test concentration
- Parameter:
- SI
- Value:
- 0.75
- Test group / Remarks:
- 30% test concentration
- Parameter:
- SI
- Value:
- 1.07
- Test group / Remarks:
- 61% test concentration
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- The raw data were expressed as disintegrations per minute (dpm) per animal and background values were determined. Individual values that fell within 3 times the background value were assigned a value of 0 (zero). Table 1 below presents the mean back-transformed least squares (BTLS) dpm and mean dpm for each group. Animals treated with organolignite show similar values when compared to the control group. The positive control responded appropriately and a significant increase in mean BTLS was observed when compared to the control.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Organolignite was determined to not be a sensitizer when tested at concentrations of 15%, 30% or 61% in Dimethyl Sulphoxide (DMSO), the highest
achievable concentration, in the Murine Local Lymph Node Assay. No adverse effects were observed during the course of this study. - Executive summary:
This study was conducted to evaluate whether the substance, organolignite, elicits skin sensitization reactions (allergic contact dermatitis) in the Murine Local Lymph Node Assay (MLLNA). This study was conducted in accordance with MPI Research Standard Operating Procedures (SOPs) and the protocol and amendments as approved by the Sponsor. A protocol deviation was acknowledged by the Study Director and documented in the raw data. In the opinion of the Study Director, this deviation did not affect the quality or integrity of the study. This study was based on Guideline 429, Skin Sensitization: Local Lymph Node Assay, the Organization for Economic Cooperation and Development (OECD) Guideline for Testing of Chemicals, revised July 2010. Organolignite was determined to not be a sensitizer when tested at concentrations of 15%, 30% or 61% (the highest achievable concentration; solvent used was dimethyl sulphoxide) in the Murine Local Lymph Node Assay. No adverse effects were observed during the course of this study.
Reference
Table 1.
Summary of Disintegrations per minute (dpm) |
||||||
|
DMSO (5) |
15% (5) |
30% (5) |
61% (5) |
Acetone/Olive Oil |
35% HCA |
Mean |
1190.4 |
989.6 |
939.8 |
1347.4 |
1004.0 |
5074.6 |
Mean BTLS |
1003.0 |
919.0 |
749.0 |
1075.0 |
897.0 |
4781.0* |
* Significantly different from Vehicle (Acetone/Olive Oil); (p<0.01)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
This study was conducted to evaluate whether the substance, organolignite, elicits skin sensitization reactions (allergic contact dermatitis) in the Murine Local Lymph Node Assay (MLLNA). This study was based on Guideline 429, Skin Sensitization: Local Lymph Node Assay, the OECD Guideline for Testing of Chemicals, revised July 2010. Organolignite was determined to not be a sensitizer when tested at concentrations of 15%, 30% or 61%, the highest achievable concentration (solvent used was Dimethyl Sulphoxide), in the Murine Local Lymph Node Assay. No adverse effects were observed during the course of this study.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Organolignite does not meet the criteria for classification and labeling as a skin sensitizer under CLP EU Regulation 1272/2008 based on the result of the mouse Local Lymph Node Assay (LLNA).
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.