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EC number: 700-155-0 | 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:
- From 17 January 2011 to 7 April 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to OECD guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- corn oil, peroxidised
- IUPAC Name:
- corn oil, peroxidised
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst / The Netherlands
- Age at study initiation: 10-11 weeks (main experiment)
- Weight at study initiation: 20.7 +/- 1.3 g
- Housing: in group, in Makrolon Type III cages, with wire mesh top
- Diet: pelleted standard diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days prior to the start of dosing under test conditions after health examination
ENVIRONMENTAL CONDITIONS
- Temperature: 22 + 2°C
- Humidity: 45-65%
- Air changes (per hr): no data
- Photoperiod: artificial light 6.00 a.m. - 6.00 p.m.
IN-LIFE DATES: from 19 January 2011 to 2 February 2011
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 25%, 50%, 100%
- No. of animals per dose:
- 4 females per group
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: a solubility experiment was performed according to the recommendations given by OECD 429. The highest test item concentration, which could be technically used was 100 % of the undiluted test item. Test item solution at different concentrations was prepared using acetone:olive oil (4+1 v/v) as vehicle.
- Irritation:
To determine the highest non-irritant test concentration that at the same time did not induce signs of systemic toxicity, a pre-test was performed in two animals.
Two mice were treated by (epidermal) topical application to the dorsal surface of each ear with test item concentrations of 75 (w/v) and 100% once daily each on three consecutive days.
Prior to the first application of the test item and before sacrifice the body weight was determined. Clinical signs were recorded at least once daily. Eventual signs of local skin irritation were documented and a score was used to grade a possible reddening of the ear skin. Furthermore, prior to the first application of the test item (day 1), on day 3 and before sacrifice (day 6) the ear thickness was determined using a micrometer. Additionally, for both animals, the ears were punched after sacrifice (day 6) at the apical area using a biopsy punch and were immediately pooled per animal and weighed using an analytical balance.
Eventual ear irritation was considered to be excessive if reddening of the ear skin of a score value T3 was observed at any observation time and/or if an increase in ear thickness of T25% was recorded on day 3 or day 6.
At the tested concentrations the animals did not show any signs of local skin irritation or systemic toxicity.
Thus, the test item in the main study was assayed at 25, 50 (w/v), and 100%. The highest concentration tested was the highest level that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation in the pre-experiment.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: at random
- Criteria used to consider a positive response:
The proliferative response of lymph node cells is expressed as the number of radioactive disintegrations per minute per lymph node (DPM/lymph node) and as the ratio of 3HTdR incorporated into lymph node cells of test lymph nodes relative to that recorded for control lymph nodes (Stimulation Index; S.I.). Before DPM/lymph node values were determined, mean scintillation-background DPM was subtracted from test and control raw data. A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the Stimulation Index.
- Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
Topical Application:
Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear with test item concentrations of 25, 50 (w/v), and 100% in acetone:olive oil (4+1 v/v). The application volume, 25 µL/ear/day, was spread over the entire dorsal surface ( 8 mm) of each ear once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals).
Administration of 3H-Methyl Thymidine:
Five days after the first topical application (day 6) 250 µL of phosphate-buffered saline (PBS) containing 19.9 µCi of 3HTdR (equivalent to 3HTdR 79.6 µCi/mL) were injected into each test and control mouse via the tail vein.
Determination of Incorporated 3HTdR
Approximately five hours after intravenous injection, the mice were sacrificed and the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a beta-scintillation counter.
In addition to the sensitising reactions the following observations and data were recorded during the test and observation period:
- Mortality / Viability: at least once daily from experimental start to necropsy.
- Body weights: in the pre-test prior to the first application and prior to sacrifice. In the main experiment: prior to the first application and prior to treatment with 3HTdR.
- Ear thickness: in the pre-test prior to the first application of the test item (day 1), on day 3 and before sacrifice (day 6).
- Ear weights: in the pre-test after sacrifice; biopsy punches were taken from each ear.
- Clinical signs (systemic toxicity or local skin irritation) were recorded at least once daily. Especially the treatment sites were observed carefully. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- not applicable
Results and discussion
- Positive control results:
- The sensitivity and reliability of the experimental technique employed was assessed by use of a substance which is known to have skin sensitisation properties in CBA/CaOlaHsd mice. The periodic positive control experiment was performed with alpha-Hexyl cinnamaldehyde in acetone:olive oil (4+1 v/v) using CBA/CaOlaHsd mice in December 2010.
SI = 1.00, 0.85, 1.85 and 7.19, respectively at 0%, 5%, 10% and25%
EC3 = 13.2% (w/v)
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 1.00, 1.43, 2.36 and 1.84 at respectively 0, 25%, 50% and 100%
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See table
Any other information on results incl. tables
Test item concentration % (w/v) |
Group |
Measurement DPM |
Calculation |
Result |
||
DPM-BG a) |
Number of lymph nodes |
DPM per lymph node b) |
S.I. |
|||
- |
BG I |
15 |
- |
- |
- |
- |
- |
BG 2 |
14 |
- |
- |
- |
- |
0 |
1 |
3470 |
3456 |
8 |
431.9 |
1.00 |
25 |
2 |
4936 |
4936 |
8 |
616.9 |
1.43 |
50 |
3 |
8157 |
8143 |
8 |
1017.8 |
2.36 |
100 |
4 |
6370 |
6356 |
8 |
794.4 |
1.84 |
BG = Background (1 ml 5% trichloroacetic acid) in duplicate
1 = Control Group
2-4 = Test Group
S.I. = Stimulation Index
a) = The mean value was taken from the figures BG I and BG II
b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
The EC3 value could not be calculated, since all S.I.´s are below the threshold value of 3.
Other observations:
- Viability / Mortality: no deaths occurred during the study period.
- Clinical Signs: no symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.
- Body Weights: the body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item peroxidised corn oil was not a skin sensitiser under the test conditions of the study.
- Executive summary:
In a study according to OECD TG 429 and GLP, the test item peroxidised corn oil dissolved in acetone:olive oil (4+1 v/v) was assessed for its possible contact allergenic potential.
For this purpose a local lymph node assay was performed using test item concentrations of 25, 50 (w/v), and 100%. The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by a pre-experiment.
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. In this study Stimulation Indices (S.I.) of 1.43, 2.36, and 1.84 were determined with the test item at concentrations of 25, 50 (w/v), and 100% in acetone:olive oil (4+1 v/v), respectively.
The test item peroxidised corn oil was not a skin sensitiser under the test conditions of this study.
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