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EC number: 242-538-0 | CAS number: 18727-04-3
- 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:
- 15 Feb 2012 - 06 Mar 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study (The LLNA is not recommended for certain metals)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted in 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted in 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium fuer Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Tricobalt dicitrate
- EC Number:
- 212-751-3
- EC Name:
- Tricobalt dicitrate
- Cas Number:
- 866-81-9
- IUPAC Name:
- tricobalt dicitrate
- Details on test material:
- - Name of test material (as cited in study report): Cobalt Citrate
- Physical state: solid
- Analytical purity: 99%
- Purity test date:
- Batch No.: 10142709
- Storage: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Additional information on strain: CBA/CaOlaHsd
- Source: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst, The Nederlands
- Age at study initiation: 8-9 weeks (pre-test: 10-12 weeks)
- Mean weight at study initiation: 19.7 g (pre-test: 21.1 g)
- Housing: 3/cage in Makrolon Type II (pre-test)/Type III (main test) with wire mesh top (Ehret GmbH, Emmendingen, Germany)
- Diet: pelleted standard diet (Harlan Laboratories V.V., Horst, Netherlands); ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 32 - 65 (acclimation phase); 45-65 (pre-test and main study)
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0.5, 1 and 2.5% (w/v)
- No. of animals per dose:
- 4 (pre-test: 2)
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: A solubility experiment was performed according to the recommendations given in the OECD guideline 429. The highest concentration which could be technically used was a 25% suspension in AOO. Grinding of the test substance was necessary.
- Irritation: To determine the highest non-irritant test concentration, that did not induce systemic signs of toxicity, a pre-test was performed in 2 animals. The animals were treated with 10 and 25% of the test substance once daily on 3 consecutive days. Besides recording of body weight, signs of toxicity and grading of erythema, ear thickness was measured before sacrifice on day 6. Excessive local erythema were seeen; therefore, a second pre-test was performed using test item concentrations of 2.5 and 5%. At both concentrations an increase in ear thickness was observed that exceeded the threshold value for excessive local skin irritation. Both animals showed erythema of the ear skin on day 4 and 5 which decreased to score 1 on day 6. At 5%, an increase in ear weight was observed that distinctly exceeded the threshold value for excessive local skin irritation. Thus, in the main study the test item was assayed at 0.5, 1, and 2.5%.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled: 1) Exposure to at least one concentration of the test item resulted in an icorporation of ³HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the Stimulation index (SI). 2) The data are compatible with a conventional dose response, although allowance must be made for either local toxicty or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
- Site: topical application at the dorsum of each ear once daily each on three consecutive days with 3 different concentrations of the test substance in AOO
- Application volume: 25 µL per application
- Control: same treatment with vehicle only
5 days after the first application, the mice were intravenously injected with radio-labelled thymidine (³H-methyl thymidine; ³HTdR) in PBS (250 µL). Approx. 5 hours after injection, the mice were sacrificed and the draining auricular lymph nodes excised and pooled per group. The proliferative capacity of pooled lymph node cells was determined by the incorporation of ³HTdR measured in a beta-scintillation counter. ³HTdR incorporation was expressedas the number of radioactive disintegrations per minute (DPM). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated.
Results and discussion
- Positive control results:
- The EC3 value of the positive controls (test performed in December 2011) was 14.4%.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: - 0.5% : 3.73 - 1%: 4.18 - 2.5%: 6.07 Since the SI values for all treatment groups were > 3, no EC3 value was determined. A clear dose-response was observed.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: - Vehicle control: 1886 - 0.5%: 6976 - 1%: 7819 - 2.5%: 11340
Any other information on results incl. tables
Table 1: LLNA – Details on results
Test item concentration (%) |
Group |
Measurement DPM |
Calculation |
Result |
||
DPM-BG a) |
No. of lymph nodes |
DPM per lymph node b) |
S.I. |
|||
- |
BG I |
19 |
- |
- |
- |
- |
- |
BG II |
20 |
- |
- |
- |
- |
0 |
1 |
1886 |
1867 |
8 |
233.3 |
1.00 |
0.5 |
2 |
6976 |
6957 |
8 |
869.6 |
3.73 |
1 |
3 |
7819 |
7800 |
8 |
974.9 |
4.18 |
2.5 |
4 |
11340 |
11321 |
8 |
1415.1 |
6.07 |
BG = background (5% trichloroacetic acid)
a) calculated with the mean value of BG I and II
b) DPM/node was determined by dividing the measured values by the number of lymph nodes pooled.
The animals did not show any signs of systemic toxicity during the study. On day 2, the animals of all test groups showed erythema of the ear skin (score = 1) and from day 3 to day 6 the observed erythema was score = 2 in all test groups.
The body weights and body weight gains were within the normal range.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Skin sens 1A, H317
DSD: Xi, R43
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