Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 617-694-1 | CAS number: 85261-19-4
- 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
The test item was tested for its acute oral toxicity potential. In total six healthy female Sprague Dawley rats were dosed orally with the test item at 2000 mg/kg. The rats were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects, and twice daily for mortality. All six female rats survived following the single 2000 mg/kg oral dose. No test item realated and toxicological relevant effects were observed after administration of the test item over the observation period of 14 days. The gross necropsy revealed no observable abnormalities. Based on these results the oral LD50 of the test item is greater than 2000 mg/kg of body weight in females rats.
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:
- 24-02-2017 to 19-07-2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Adopted: 17th december 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
Animal Requirements:
- Number of Animals : 6 animals
- No. Animals/Group : 3 - 6
4.1.4: Sex : Females (nulliparous and non-pregnant)
(Justification required for the use of males)
(Refer to Section 4.2.2 of this protocol)
- Species/ Strain : Rat/Sprague Dawley
- Age/Weight : 8 to 12 weeks / +/- 20% of mean weight of previously dosed animals within a sex
Husbandry:
- Housing: Animals will be housed in suspended wire cages which conform to the size recommendations in Guide for the Care and Use of Laboratory Animals DHEW (NIH). Rats will be housed 5 per sex per cage prior to dosing and 3 per sex per cage following dosing. Absorbent paper bedding, placed beneath the cage, will be changed at least three times per week. The animal room, reserved exclusively for rodents on acute tests, is temperature controlled, has a 12-hour light/dark cycle, and will be kept clean and vermin free.
- Acclimation: The test animals will be conditioned to the housing facilities for at least five days prior to testing.
- Food: Fresh PMI Rat Chow (Diet #5012) will be available except 16 - 20 hours prior to dosing.
- Water: Water will be available ad libitum.- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/kg BW
- No. of animals per sex per dose:
- 3 females + 3 females
- Control animals:
- no
- Details on study design:
- Initially, three healthy female Sprague Dawley rats were dosed orally with MTDID 48740 the test item at 2000 mg/kg. In addition, three healthy females were dosed as a confirmatory group at 2000 mg/kg. The rats were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects, and twice daily for mortality. Body weights were recorded immediately pretest, weekly and at termination. All animals were examined for gross
pathology. The test article was assigned to a toxic category based on the mortality response noted. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality occurred until the end of observation period.
- Clinical signs:
- other: non-specific and sporadic physical signs including wetness on the nose/mouth area (n=3) directly after adminstration, wetness and yellow staining on the anogenital area (n=3, only at the first day after oral administration), chromorhinorrhea (n=3, in one
- Gross pathology:
- No abnormalities observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD 50> 2000 mg/kgBW
- Executive summary:
The acute oral toxicity study of the test item was performed according to OECD Test Guideline 423.Initially, three healthy female Sprague Dawley rats were dosed orally with the test item at 2000 mg/kg. In addition, three healthy females were dosed as a confirmatory group at 2000 mg/kg. The rats were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects, and twice daily for mortality. All six female rats survived following the single 2000 mg/kg oral dose. No test item realated and toxicological relevant effects were observed after administration of the test item over the observation period of 14 days. The gross necropsy revealed no observable abnormalities. Based on these results the oral LD50 of the test item is greater than 2000 mg/kg of body weight in females rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- reliable without restrictions (GLP-Study according to OECD 423)
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
Justification for classification or non-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.
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.