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Diss Factsheets
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EC number: 800-777-3 | CAS number: 1351378-24-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Oral, rat: estimated LD50: 1000 mg/kg bw (Colas, 2012)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 - 30 May 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GROUPE INTERMINISTERIEL DES PRODUITS CHIMIQUES
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER, Le Genest St Isle, France
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 183 - 231 g
- Fasting period before study: animals were fasted one day prior to substance administration until 4 hrs after substance administration (diet only).
- Housing: 3 animals per cage in solid-bottomed clear polycarbonate cages with stainless steel mesh lids
- Diet: M20 (pelleted), Specific Diet Services, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
2000 mg/kg bw: 200 mg/mL
300 mg/kg bw: 30 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 (controls), 12 (test substance group; 3 animals per step in a two-step testing procedure with 2 concentrations)
- Control animals:
- other: 3 animals received 10 mL/kg bw olive oil via gavage in a current control study performed from 14 Feb - 28 Feb 2012
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed 0.5, 1, 3 and 4 h after substance administration and daily thereafter and individual body weights were determined periodically on day 0 (prior to substance administration), 2, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: macroscopical examination of oesophagus, stomach, duodenum, jejunum, ileon, caecum, colon, rectum, spleen, liver, thymus, trachea, lungs, heart, kidneys, urinary bladder, ovaries, uterus, adrenals and pancreas - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 cut-off according to OECD 423
- Mortality:
- 2000 mg/kg bw: In the first step, 2/3 animals died (2 or 4 days after substance application); in the second step, 3/3 rats died (Day 2, 3 and 4)
300 mg/kg bw: No mortality was observed during the study period.
For details, please refer to Table 1 under "Any other information on results". - Clinical signs:
- other: 2000 mg/kg bw: Mortalities were preceded by a decrease in muscle tone and piloerection in 2/5 and 5/5 rats, respectively. The surviving high-dose animal showed piloerection after dosing. 300 mg/kg bw: Decreased spontaneous activity and piloerection was o
- Gross pathology:
- 2000 mg/kg bw: Non-surviving animals: Rigor mortis was noted before necropsy in 5/5 animals. Marked lysis preventing macroscopical examinations was observed in 3/5 animals. Examination of the other animals revealed thinning of the forestomach in 1/5 animals with red coloration, black coloration of the forestomach, black coloration of the corpus (1/5) and thinning of the corpus (2/5).
Surviving animals: The surviving high-dose animal revealed a thickening of the forestomach.
300 mg/kg bw: Macroscopical examinations revealed no substance-related findings. - Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Acute Oral 4, H302
DSD: Xn, R22
Reference
Table 1. Mortality and clinical signs after test substance administration.
Dose |
Toxicological results* |
Duration of clinical signs |
Time of death |
Mortality (%) |
Females |
||||
300 |
3/2/6 |
0.5 – 3 h |
--- |
0 |
2000 |
5/6/6 |
0.5 h - Day 3 |
Day 2, |
83% |
LD50 cut off = 1000 mg/kg bw |
* first number = number of dead animals
second number = number of animals with clinical signs
third number = number of animals used
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 000 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute Toxicity
Oral Route
A GLP-guideline study according to the acute toxic class method (OECD 423) was performed to determine hazardous properties of 2-Butenedioic acid (2Z)-, reaction products with ammonium di-µ3-hydroxyhexacosa-µ-oxododecaoxododecatungstate(6-) (6:1), ammonium octa-µ-oxodi-µ3-oxo-µ4-oxododecaoxoheptamolybdate(6-) (6:1), nickel(2+) nitrate (1:2) and nickel(2+) sulfate (1:1) after acute exposure (Colas, 2012). Exposure to 2000 mg/kg bw revealed mortality of 5/6 female Sprague Dawley rats which was accompanied by a decrease in body weight, muscle tone and piloerection. No mortality was observed after gavage of the next lower dose of 300 mg/kg bw. Pathological examinations of non-surviving animals showed rigor mortis prior to necropsy, marked lysis in 3/5 animals preventing macroscopical examinations and thinning of the forestomach (1/5 animals) and the corpus (2/5 animals) in the remaining animals. In contrast to the surviving high-dose animal, which revealed thickening of the forestomach, no substance – related findings were noted in low-dose animals. According to OECD 423, a LD50 cut-off value of 1000 mg/kg bw was defined in the conducted study.
Justification for selection of acute toxicity – oral endpoint
There is only one study available.
Justification for classification or non-classification
The available data on acute oral toxicity meet the classification criteria as harmful if swallowed according to Regulation (EC) 1272/2008 and Directive 67/548/EEC. No data on acute dermal and inhalation toxicity are available.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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