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EC number: 938-871-2 | CAS number: 6613-31-6
- 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:
- 2012
- Reliability:
- 1 (reliable without restriction)
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)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 8-(butan-2-yl)-5,6,7,8-tetrahydroquinoline
- EC Number:
- 938-871-2
- Cas Number:
- 6613-31-6
- Molecular formula:
- C13H19N
- IUPAC Name:
- 8-(butan-2-yl)-5,6,7,8-tetrahydroquinoline
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5, 10, 25%
- No. of animals per dose:
- 5
Results and discussion
Any other information on results incl. tables
Table 2: Calculation of Stimulation Indices per Dose Group Group Calculation Test item concentration Mean DPM per animal (2 lymph nodes) a) SD S.I. Vehicle Control Group for the Test Item (acetone:olive oil (4+1 (v/v))) 479.3 79.3 1.00 5% GR-50-0572 1295.7 b) 258.3 2.70 10% GR-50-0572 1940.1 b) 503.8 4.05 25% GR-50-0572 5208.3 b) 925.6 10.87 Positive Control Group (25% X -HCA) 5160.1 b) 2268.0 10.77 a) Mean DPM/animal was determined by dividing the sum of the measured values from lymph nodes of all animals within a group by the number of animals in that group (5 animals) b) Statistically significant increase in comparison to the control group (p
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In the study the test item GR-50-0572 dissolved in acetone:olive oil (4+1 (v/v)) was
assessed for its possible skin sensitising potential.
For this purpose a local lymph node assay was performed using test item concentrations
of 5, 10, and 25% (w/w). The highest concentration tested was the highest concentration
that could be applied whilst avoiding systemic toxicity and excessive local skin irritation as
confirmed by two pre-experiments.
The animals did not show any signs of systemic toxicity or local skin irritation during the
course of the study and no cases of mortality were observed. A statistically significant
increase in ear weight was observed in the positive control group. For the measured ear
thickness, this was not observed. For the test groups, neither the measured ear weights
nor the ear thickness showed a statistically significant or biologically relevant increase in
comparison to the vehicle control group.
In this study Stimulation Indices (S.I.) of 2.70, 4.05, and 10.87 were determined with the
test item at concentrations of 5, 10, and 25% (w/w) in acetone:olive oil (4+1 (v/v)),
respectively. A statistically significant increase was observed in comparison to the vehicle
control group (p<0.05) and a clear dose response was obtained.
An outlier was identified in the vehicle control group and in the high dose group (DPM
value determined for animals number 2 and 19). However, as exclusion of the outliers did
not have an influence on the overall test result, the values in question were not excluded
from calculation.
The S.I. determined with the positive control was 10.77, demonstrating the validity of the
study.
The test item GR-50-0572 was found to be a skin sensitiser and an EC3 value of
6.1% (w/w) was derived.
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