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EC number: 229-177-4 | CAS number: 6422-99-7
- 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
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:
- From 07 August 2012 to 08 January 2013.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (OECD 429), well performed without any deviation.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Date: 19 DEC 2012)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/Ca (CBA/CaOlaHsd)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: eight to twelve weeks old.
- Weight at study initiation: the weight range of 15 to 23 g
- Housing: individually
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK.
- Water (e.g. ad libitum): tap water
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light - Vehicle:
- other: Pluronic L92
- Concentration:
- - Preliminary test: 25% w/w in 1% pluronic L92 in distilled water.
- Main test: 25%, 10% and 1% w/w in 1% pluronic L92 in distilled water. - No. of animals per dose:
- 1 female per dose for the preliminary test.
4 females per dose for the main test. - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: the test item was prepared as a solution in 1% pluronic L92 in distilled water (BASF, Batch: WPAG522B). This vehicle was chosen as all other vehicles were unsuitable for dosing which was at a concentration of 25% w/w.
- Irritation: Using available information regarding the systemic toxicity/irritancy potential of the test item, a preliminary screening test was performed using one mouse at a concentration of 25% w/w in 1% pluronic L92 in distilled water. No signs of systemic toxicity, visual local skin irritation or irritation indicated by an equal to or greater than 25% increase in mean ear thickness were noted. Based on this information the dose levels selected for
the main test were 25%, 10% and 1% w/w in 1% pluronic L92 in distilled water.
- Lymph node proliferation response: not performed.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response:
The test item will be regarded as a sensitiser if at least one concentration of the test item results in a threefold or greater increase in 3HTdR incorporation compared to control values. Together with consideration of a dose-response relationship other relevant criteria such as radioactivity levels and ear thickness are also taken into account to evaluate the data.
Any test item failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a "non sensitiser".
TREATMENT PREPARATION AND ADMINISTRATION:
The animals were topically dosed with 25 µL of the appropriate formulation using a pipette on the dorsal surface of each ear. Each animal was dosed once a day for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6.
On Day 6, animals were taken to the radioactive suite and each mouse was intravenously injected via the tail vein with 250 µL of sterile PBS (phosphate buffered saline) containing approximately 20 µCi of 3HTdR. Once injected, the mice were left for 5 hours. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- The stimulation Index for the positive control tested on June 2012 at a concentration of 25% v/v in 1% pluronic L92 in distilled water was 7.20. This gave a positive result for sensitisation potential.
- Parameter:
- SI
- Remarks on result:
- other: No notable lymphoprofileration was noted with the test item at any tested concentrations. The observed stimulation index values were 1.75, 1.30 and 1.84 at concentrations of 25, 10 and 1 ( % w/w) in 1% pluronic L92 in distilled water respectively.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See Table 7.4.1/1
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions of this study, the test item, sebacic acid, compound with hexane-1,6-diamine (1:1), gave a negative result in the murine Local Lymph Node Assay, indicative of the absence of skin sensitization properties.
- Executive summary:
In a dermal sensitization study performed according to the OECD test guideline No. 429 and in compliance with Good Laboratory Practice (Henzell, 2012), sebacic acid, compound with hexane-1,6-diamine (1:1) was tested in female CBA/Ca strain mice using the Local Lymph Node Assay.
A vehicle determination was performed with the test item before preliminary testing commenced. All vehicles were unsuitable in the Local Lymph Node Assay apart from 1% pluronic L92 in distilled water which showed suitability at a concentration was 25% w/w.
A preliminary irritation/toxicity test was first performed in order to define the concentrations of test item to be used in the main test.
In the main test, three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test item as a solution in 1% pluronic L92 in distilled water at concentrations of 25%, 10% or 1% w/w. A further group of four animals was treated with 1% pluronic L92 in distilled water alone. The test item solutions were applied on the dorsal surface of ears of experimental animals (25µl/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. On Day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine ((3H-TdR) and the values obtained were used to calculate stimulation indices (SI).
No mortality or systemic clinical signs were observed during the study. No treatment related effects were observed on animal body weights in any treated groups. No notable lymphoprofileration was noted with the test item at any tested concentrations. The observed Stimulation Index values were 1.75, 1.30 and 1.84 at concentrations of 25, 10 and 1 (% w/w) in 1% pluronic L92 in distilled water respectively.
The Stimulation Index for the positive control (α‑Hexylcinnamaldehyde, tech., 85%, tested on June 2012) at a concentration of 25% v/v in 1% pluronic L92 in distilled water was 7.20. This gave a positive result for sensitisation potential.
Under the experimental conditions of this study, the test item, sebacic acid, compound with hexane-1,6-diamine (1:1), gave a negative result in the murine Local Lymph Node Assay, indicative of the absence of skin sensitization properties. Based on these results, no classification is required according to the Regulation (EC) No. 1272/2008 (CLP) and the Directive 67/548/EEC criteria.
Reference
Table 7.4.1/1 Disintegrations per Minute, Disintegrations per Minute/Node and Stimulation Index
Concentration |
Dpm/group |
dpm/Nodea |
Stimulation Indexb |
Result |
Vehicle |
9850.00 |
1231.25 |
na |
na |
1 |
18124.54 |
2265.57 |
1.84 |
negative |
10 |
12780.17 |
1597.52 |
1.30 |
negative |
25 |
17237.32 |
2154.67 |
1.75 |
negative |
a= Disintegrations per minute/node obtained by dividing the disintegrations per minute value by 8 (total number of lymph nodes)
b= Stimulation Index of 3.0 or greater indicates a positive result
na = Not applicable
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A dermal sensitization study was performed according to the OECD test guideline No. 429 and in compliance with Good Laboratory Practice (Henzell, 2012) with sebacic acid, compound with hexane-1,6-diamine (1:1), in female CBA/Ca strain mice using the Local Lymph Node Assay.
A vehicle determination was performed with the test item before preliminary testing commenced. All vehicles were unsuitable in the Local Lymph Node Assay apart from 1% pluronic L92 in distilled water which showed suitability at a concentration was 25% w/w.
A preliminary irritation/toxicity test was first performed in order to define the concentrations of test item to be used in the main test.
No mortality or systemic clinical signs were observed during the study. No treatment related effects were observed on animal body weights in any treated groups. No notable lymphoprofileration was noted with the test item at any tested concentrations. The observed Stimulation Index values were 1.75, 1.30 and 1.84 at concentrations of 25, 10 and 1 (% w/w) in 1% pluronic L92 in distilled water respectively.
The Stimulation Index for the positive control (α‑Hexylcinnamaldehyde, tech., 85%, tested on June 2012) at a concentration of 25% v/v in 1% pluronic L92 in distilled water was 7.20. This gave a positive result for sensitisation potential.
Under the experimental conditions of this study, the test item, sebacic acid, compound with hexane-1,6-diamine (1:1), gave a negative result in the murine Local Lymph Node Assay, indicative of the absence of skin sensitization properties.
Migrated from Short description of key information:
A GLP, LLNA (OECD 429) study performed with sebacic acid, compound with hexane-1,6-diamine (1:1) showed the absence of skin sensitization potential.
Justification for selection of skin sensitisation endpoint:
Only available study. GLP and OECD 429 compliant study.
Justification for classification or non-classification
Based on the negative results obtained in the performed LLNA test with sebacic acid, compound with hexane-1,6-diamine (1:1),
no classification is required according to the Regulation (EC) No. 1272/2008 (CLP) and the Directive 67/548/EEC criteria.
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