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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 432-820-3 | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 March 2000 to 23 March 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: March 23rd 1998 Date of signature: July 21st 1998
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Details on test material:
- Sponsor's identification :S178207/1
Batch number :SI/2000/013-NBZ0166/44
Date received :14 February 2000
Description :off white powder
Storage conditions :room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: eight to twelve weeks old.
- Weight at study initiation: males weighed 210 to 240 g, and the females 212 to 224 g
- Fasting period before study: Overnight fast immediately before study
- Housing: The animals were housed in groups of three by sex in solid-floor polypropylene cages furnished with woodflakes.
- Diet: ad libitum - Rat and Mouse Expanded Diet No.1, Special Diets Services Limited, Witham, Essex, UK.
- Water: ad libitum - mains drinking water
- Acclimation period: acclimatisation period of at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): controlled by a time switch to give twelve hours continuous light and twelve hours darkness.
IN-LIFE DATES: From: Day 0 To: Day 14
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: not stated in report
- Amount of vehicle (if gavage): 10 ml/kg - The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing.
- Justification for choice of vehicle: not stated in report
- Lot/batch no. (if required): not stated in report
- Purity: not stated in report
MAXIMUM DOSE VOLUME APPLIED: The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing. (Not described in any more detail in report).
DOSAGE PREPARATION (if unusual):not applicable
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: the use of all available information - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 females and then 3 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment or death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Determination of LD50
Results and discussion
- Preliminary study:
- One female found dead during the day of dosing.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two animals (one male and one female) were found dead during the day of dosing.
- Clinical signs:
- Clinical signs of toxicity commonly noted were ataxia, hunched posture, lethargy, decreased respiratory rate, laboured or noisy respiration and splayed or tiptoe gain with incidents of pallor of the extremities and emaciation.
- Body weight:
- The surviving animals showed expected gains in bodyweight over the study period.
- Gross pathology:
- Abnormalities noted at necropsy of animals that died during the study were haemorrhagic lungs, dark liver and dark kidneys. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
- Other findings:
- - Organ weights: not determined
- Histopathology: not determined
- Potential target organs: not determined
- Other observations: none
Any other information on results incl. tables
The acute oral LD50of the test material, S178207/1, in the Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 of the test material, S178207/1, in the Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight, therefore no symbol and risk phrase are required according to EU labelling regulations.
- Executive summary:
A study was performed to assess the acute oral toxicity of the test material following a single oral administration to the Sprague-Dawley CD strain rat. The method followed that in the OECD Guidelines for Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute Toxic Class Method" (adopted 22 March 1996) and Method B1 tris of Commission Directive 96/54/EC (which constitutes Annex V of Council Directive 67/548/EEC).
Using all available information, 2000 mg/kg bodyweight was selected as the starting dose. A group of three fasted females was treated with the starting dose. This was followed by a group of three fasted animals of the other sex at the same dose level.The test material was administered orally as a suspension in arachis oil BP. The animals were observed ½, 1, 2 and 4 hours after dosing and then once daily for up to fourteen days. Bodyweights were recorded on Day 0 (day of dosing) and on Days 7 and 14, or at death. At the end of the observation period all the surviving animals were killed by cervical dislocation and all animals were subjected to gross necropsy.
Two animals (one male and one female) were found dead during the day of dosing.
Clinical signs of toxicity commonly noted were ataxia, hunched posture, lethargy, decreased respiratory rate, laboured or noisy respiration and splayed or tiptoe gain with incidents of pallor of the extremities and emaciation.
The surviving animals showed expected gains in bodyweight over the study period. Abnormalities noted at necropsy of animals that died during the study were haemorrhagic lungs, dark liver and dark kidneys. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
The acute oral median lethal dose, (LD50) of the test material, in the Sprague-Dawley CD strain rat, was estimated as being greater than 2000 mg/kg bodyweight. No symbol and risk phrase are required according to EU labelling regulations.
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.
Although ECHA is providing a lot of online material in your language, part of this page is only in English. More about ECHA’s multilingual practice.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
the-echa-website-uses-cookies
find-out-more-on how-we-use-cookies