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EC number: 807-715-4 | CAS number: 1354569-12-2
- 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
An oral limit test in rats (OECD 423, non-GLP, Klimisch 2).
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:
- 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP screening test
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- method based on 423 but only 2 animals were used
- Principles of method if other than guideline:
- Two female rats were treated with with bis-(2-ethylhexyl)-citraconate at 2000 mg/kg bw by oral gavage as a screening acute oral toxicity limit test. Adminstration of the single dose were folled by a 14 day observation period and gross necropsy. Two rats are considered to be the lowest number that can be used to make a realistic estimate for a limit screen, in line with animal welfare needs.
- GLP compliance:
- no
- Remarks:
- This Limit Test was conducted as a screening tests for the PPORD and intermediate registration purposes only. Even if it was not conducted under GLP, the laboratory had a valid GLP certificate.
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Source: RccHan: (WIST) rats, source Harlan Laboratories, R.r.l., S. Petro al Natisone (UD), Zona Industriale Azzida, 57, 33040 Italy.
Young, healthy, adult, 8 - 12 week old females, nulliparous, non pregnant animals, 150 - 300 g.
Acclimatisation period at least 5 days.
Group caging (2/cage), type II/polypropylene/polycarbonate, certified laboratory wood bedding.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 +- 3oC, rH 30 - 70 %, 15 - 20 air exchanges/hour, recorded twice daily.
Food ssniff(R) SM R/M Autoclavable complete diet for rats and mice ad libitum, tap water from municipal supply 500 mL bottle ad libitum. - Route of administration:
- oral: gavage
- Vehicle:
- other: sunflower oil
- Details on oral exposure:
- Freshly prepared test item at was administered as a single oral dose. The formulation was stirred with a magnetic stirrer up to finishing the treatment.
- Doses:
- Freshly prepared test item at concentration 200 mg/mL was administered as a single oral dose at a dosing volume 10 mL/kg bW.
- No. of animals per sex per dose:
- 2
- Control animals:
- no
- Details on study design:
- Clinical observatios were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weight was measured on days -1, 0. 7 and 14 just before necropsy. Both animals were subjected to a necropsy and a macroscopic examination.
- Statistics:
- Two test animals, 20 clinical observations per animal, mean body weight and body weight gains were reported and standard deviations calculated.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality at a dose level of 2000 mg/kg bw (appendix 1).
- Clinical signs:
- other: There were no clinical signs during the 14 days observation period after treatment at 2000 mg/kg bw (Appendix 2).
- Gross pathology:
- There was no evidence of macroscopic effects at necropsy at a dose level of 2000 mg/kg bw (appendix 4).
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance was not toxic in an acute oral limit test in rats (LD50 was > 2000 mg/kg bw).
- Executive summary:
The test substance was not toxic in an acute oral limit test in rats (LD50 was > 2000 mg/kg bw; non-GLP OECD 423 screening test). The non-GLP test is rated as reliable with restrictions (Klimisch 2).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Klimisch 2
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
The test substance was not toxic in an acute oral limit test in rats (LD50 was > 2000 mg/kg bw; non-GLP OECD 423 screening test). The non-GLP test is rated as reliable with restrictions (Klimisch 2).
Justification for selection of acute toxicity – oral endpoint
The classification criterion is not met.
Justification for selection of acute toxicity – inhalation endpoint
In accordance with REACH Article 18, the study is not required.
Justification for selection of acute toxicity – dermal endpoint
In accordance with REACH Article 18, the study is not required.
Justification for classification or non-classification
The substance does not meet the classification criteria for acute oral toxicity.
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