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Diss Factsheets
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EC number: - | 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:
- July 14 - September 3, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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:
- 6-Hydroxy-2,6-dimethylheptan-1-al
- Cas Number:
- 62439-42-3
- Molecular formula:
- C9H18O2
- IUPAC Name:
- 6-Hydroxy-2,6-dimethylheptan-1-al
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-23 g
- Housing: suspended solid floor polypropylene cages
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent Diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 degrees C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: July 16, 2014 To: August 13, 2014
Study design: in vivo (LLNA)
- Vehicle:
- other: Ethanol/diethylphthalate 1:3
- Concentration:
- 50% v/v in ethanol/diethylphthalate 1:3
25% v/v in ethanol/diethylphthalate 1:3
100% - No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
- Irritation: No signs of irritation were noted
- Systemic toxicity: No signs of systemic toxicity were noted
- Ear thickness measurements: No ear thickness increase of greater than 25% was noted
- Erythema scores: 0
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: Threefold or greater increase in 3HTdR incorporation.
TREATMENT PREPARATION AND ADMINISTRATION: Test formulations were made within 2 hours of being applied. Daily application of 25 uL of test solution on the dorsal surface of each ear for three consecutive days. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Dose response relationships determined by analysis of homogeneity of variance followed by ANOVA. Significant results from ANOVA were analyzed by pairwise comparisons. Dunnett's Multiple Comparison test was used for homogenous datasets, and Dunnett's T3 Multiple Comparison Method was used for non-homogenous datasets.
Results and discussion
- Positive control results:
- Stimulation index: 15.91
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 5.62
- Test group / Remarks:
- 100% concentration
- Key result
- Parameter:
- SI
- Value:
- 5.98
- Test group / Remarks:
- 50% concentration
- Key result
- Parameter:
- SI
- Value:
- 2.7
- Test group / Remarks:
- 25% concentration
- Key result
- Parameter:
- EC3
- Value:
- 27.29
- Test group / Remarks:
- Based on 25%, 50%, and 100% concentrations
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
The stimulation index was calculated by determining the mean radioactive incorporation for each test group, and dividing this by the mean radioactive incorporation for the vehicle control group.
EC3 CALCULATION
EC3= c + [[(3-d)/(b-d)] x (a-c)] where a = 50, b = 5.98, c = 25, and d = 2.70
CLINICAL OBSERVATIONS: No adverse clinical signs were observed.
BODY WEIGHTS: Body weight changes in the test groups were similar to the vehicle control group.
SIGNS OF TOXICITY (including dermal irritation at the site of administration, if any, e.g. increased ear thickness).
No signs of systemic toxicity were observed.
Any other information on results incl. tables
Disintegrations per minute
Treatment Group | Animal Number | Disintegrations per Minute |
Vehicle | 1-1 | 1747.26 |
Vehicle | 1-2 | 2648.27 |
Vehicle | 1-3 | 653.98 |
Vehicle | 1-4 | 897.54 |
Vehicle | 1-5 | 1023.14 |
Mean dpm/Animal | 1394.04(+/-810.81) | |
25% | 2-1 | 4499.58 |
25% | 2-2 | 4233.69 |
25% | 2-3 | 4213.46 |
25% | 2-4 | 3792.26 |
25% | 2-5 | 2053.44 |
Mean dpm/Animal | 3758.49(+/-986.20) | |
50% | 3-1 | 7972.5 |
50% | 3-2 | 14354.64 |
50% | 3-3 | 34794.89 |
50% | 3-4 | 4304.62 |
50% | 3-5 | 6735.07 |
Mean dpm/Animal | 8341.71(+/-4288.40, excludes outlier animal 3-3) | |
100% | 4-1 | 8951.52 |
100% | 4-2 | 6870.22 |
100% | 4-3 | 7371.75 |
100% | 4-4 | 10779.57 |
100% | 4-5 | 5208.36 |
Mean dpm/Animal | 7836.28 | |
Positive Control | 5-1 | 25621.3 |
Positive Control | 5-2 | 27410.54 |
Positive Control | 5-3 | 25399.66 |
Positive Control | 5-4 | 24164.43 |
Positive Control | 5-5 | 8301.48 |
Mean dpm/Animal | 22179.48(+/-7844.08) |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The test substance is a skin sensitizer.
- Executive summary:
The potential for dermal sensitization for the test substance was determined in an OECD Guideline 429 Local Lymph Node Assay test. Test concentrations of 25%, 50%, and 100% of the test substance in ethanol/diethylphthalate 1:3 were used. Hexyl cinnamic aldehyde was used as a positive control. 5 animals per dose were tested. Test solutions were applied for three consecutive days. A threefold or greater increase in 3HTdR incorporation was considered a positive response. The stimulation index results were as follows: 2.7 (25%), 5.98 (50%), 5.62 (100%), and 15.91 (positive control). The EC3 was calculated to be 27.29. Based on the results, the test substance is considered a skin sensitizer.
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