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EC number: 214-202-3 | CAS number: 1113-38-8
- 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
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Endpoint summary
Administrative data
Description of key information
Skin sensitisation (OECD 429, GLP): not sensitising
Despite of CAS number belonging to an anhydrous form of diammonium oxalate in the name of the link below, diammonium oxalate monohydrate (CAS#6009-70-7) was used as a test material for skin sensitization studies. This is reflected respectively in the test material information of relevant study.
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:
- 01 - 23 June 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 22 Jul 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayrisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories GmbH, Venray, The Netherlands
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 17 - 21 g (main test); 17 - 23 g (pre-test)
- Housing: 5 animals per group were housed in IVC cages, type II L, polysulphone cages on Altromin saw fibre bedding.
- Diet: Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 01 June 2016 To: 23 June 2016 - Vehicle:
- other: aqua ad injection
- Remarks:
- containing 2% CMC
- Concentration:
- 1.5, 3 and 6%
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS: 2 female mice per concentration were treated by daily application of 25 μl with a test substance concentration of 3 and 6% in aqua ad injection, respectively, to the dorsal surface of the ear, for 3 consecutive days. The body weight was recorded on Day 1 prior to dosing and on Day 6.
- Compound solubility: The test substance was insoluble in acetone/olive oil (4:1), DMSO and polyethylenglycol, respectively. The maximum, technically applicable concentration of the test substance in the vehicle was found to be 6.25% in aqua ad injectionem.
- Irritation: The animals were observed daily for local irritation at the application site.
- Systemic toxicity: The animals were observed daily for any signs of toxicity.
- Ear thickness measurements: Ear thickness measurements were performed on Day 1, 3 and 6, respectively.
- Erythema scores: Draize scoring system
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation determined by β-scintillation
- Criteria used to consider a positive response: The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (disintegrations per minute/node) and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index). Before DPM/NODE values were determined, background values were subtracted. The test material will be regarded as a sensitiser if at least one concentration of the test material results in a threefold or greater increase in 3HTdR incorporation compared to control values (SI ≥ 3.0).
- Other: The animals were observed for signs of toxicity once daily. The body weight was recorded on Day 1 prior to dosing and on Day 6 prior to termination.
TREATMENT PREPARATION AND ADMINISTRATION: 25 µl of the test material was applied to the entire dorsal surface of each ear of each mouse on Day 1, 2 and 3 in concentrations of 1.5, 3 and 6% in aqua ad injetionem. The irritation effects at the treatment site and any signs of systemic toxicity were assessed daily. On Day 6 an injection of 250 µl phosphate buffered saline (PBS) containing 20 µCi of 3H-methyl thymidine (3H-TdR) was made into the tail vein of each experimental mouse. Approximately five hours later, the draining auricular lymph nodes of each ear were excised into PBS and pooled per experimental group. A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through a 200-mesh stainless steel gauze and rinsed with PBS. The precipitates were incubated for approximately 18 h at approximately 4 °C, centrifuged, resuspended in 1 mL 5% TCA and transferred to 7 mL scintillation fluid before β-scintillation counting. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- A shared positive control hexyl cinnamic aldehyde (25%) in aqua ad injectionem was performed concomitantly using 5 animals and was considered to be a sensitizer under the conditions of the test (SI 9.8).
- Key result
- Parameter:
- SI
- Value:
- 1
- Variability:
- 0.1
- Test group / Remarks:
- 1.5%
- Key result
- Parameter:
- SI
- Value:
- 0.9
- Variability:
- 0.3
- Test group / Remarks:
- 3%
- Key result
- Parameter:
- SI
- Value:
- 1.4
- Variability:
- 0.2
- Test group / Remarks:
- 6%
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
The SI of the 1.5, 3 and 6% treatment group was 1.0, 0.9 and 1.4, respectively. None of the test substance concentrations produced an 3-fold increase in 3HTdR incorporation.
EC3 CALCULATION
None of the SI values were above 3 and it is therefore not possible to determine an EC3 concentration.
CLINICAL OBSERVATIONS
No mortality and no signs of systemic toxicity were noted in the test or negative control group. Wet fur at the application site was observed in 4/5 animals of the positive control on Day 2.
BODY WEIGHTS
Body weight changes were comparable to those observed in the corresponding control group animals over the same period. - Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: not classified
Reference
Table 1: Summary of results
DPM | DPM - mean background | DPM/node | Mean DPM/node | SI | |
Negative Control | 1947 | 1926.6 | 963.3 | 700.5± 219.9 | 1.0 |
697 | 676.6 | 338.3 | |||
1534 | 1513.6 | 756.8 | |||
1738 | 1717.6 | 858.8 | |||
1191 | 1170.6 | 585.3 | |||
1.5% | 1351 | 1330.6 | 665.3 | 727.9± 68.6 | 1.0± 0.1 |
1274 | 1253.6 | 626.8 | |||
1575 | 1554.6 | 777.3 | |||
1562 | 1541.6 | 770.8 | |||
1619 | 1598.6 | 799.3 | |||
3% | 991 | 970.6 | 485.3 | 647.3± 209.9 | 0.9± 0.3 |
1978 | 1957.6 | 978.8 | |||
824 | 803.6 | 401.8 | |||
1186 | 1165.6 | 582.8 | |||
1596 | 1575.6 | 787.8 | |||
6% | 2166 | 2145.6 | 1072.8 | 998.9± 126.3 | 1.4± 0.2 |
1727 | 1706.6 | 853.3 | |||
2081 | 2060.6 | 1030.3 | |||
1738 | 1717.6 | 858.8 | |||
2379 | 2358.6 | 1179.3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitising potential of the test substance was evaluated in a LLNA test according to OECD TG 429 and in compliance with GLP (reference 7.4.1-1). The study was conducted on five female mice per dose group (1.5, 3 and 6%). 25 µL of the test material was applied to the entire dorsal surface of each ear of each mouse on Day 1, 2 and 3 in concentrations of 1.5, 3 and 6% in aqua ad injection. On Day 6 an injection of 250 µL phosphate buffered saline (PBS) containing 20 µCi of 3H-methyl thymidine (3H-TdR) was made into the tail vein of each experimental mouse. Five hours later, animals were sacrificed, and the draining auricular lymph nodes removed and prepared for cell suspension and scintillation counting. A vehicle control group and a shared positive control group (25% hexylcinnamaldehyde in aqua ad injection) of five animals each were run concurrently, confirming the reliability of the test system. The test substance produced a stimulation index smaller than 3 in all groups and is therefore not considered as skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation of the test substance do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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