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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 429-100-6 | CAS number: 23911-56-0
- 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
Acute oral toxicity
The acute oral toxicity of the test item was tested according to OECD guideline 401. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 200 mg/kg but less than 2000 mg/kg bodyweight.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted 24 February 1987)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- CD (Crl : CD ® BR)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Rationale for use of males: Both males and females were used to compare both sexes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 203 to 221 g (males) and 211 to 228 g (females)
- Fasting period before study: Overnight
- Housing: In groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet: Ad libitum (except fastig period before dosing and 3-4 hours after dosing)
- Water: Ad libitum (except fastig period before dosing and 3-4 hours after dosing)
- Acclimation period: At least five days
- Method of randomisation in assigning animals to test and control groups: Animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 48-55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From day 0 to day 14 - Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2.5, 20 and 200 mg/mL (dose-range finding test) and 20 mg/mL (main study)
- Amount of vehicle: 10 mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL
DOSAGE PREPARATION: The test material was warmed in a warming bath to produce a liquid and then freshly prepared, as required, as a solution at the appropriate concentration in arachis oil BP. - Doses:
- 25, 200 and 2000 mg/kg bw (dose range finding study) and 200 mg/kg bw (main study)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to dosing on day 0 and on days 7 and 14.
- Necropsy of survivors performed: Yes - Statistics:
- Not specified
- Preliminary study:
- A range-finding study was performed to establish a dosing regime. One male and one female animal were exposed to 25, 200 and 2000 mg/kg bw. Animals treated with 2000 mg/kg were found dead one day after dosing. Clinical signs of toxicity noted were hunched posture, Iethargy, ataxia, decreased respiratory rate, ptosis and pilo-erection. Based an this information, a dose level of 200 mg/kg bodyweight was selected for the main study.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD100
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 200 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 200 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths at 200 mg/kg bw (main study). At 2000 mg/kg bw (range finding test), all animals died.
- Clinical signs:
- other: Common signs of systemic toxicity noted were lethargy and/or hunched posture during the day of dosing. All animals recovered one day after dosing (main study at 200 mg/kg bw). Animals dose with 2000 mg/kg bw showed hunched posture, Iethargy, ataxia, decre
- Gross pathology:
- No abnormalities were noted at necropsy.
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Similar to ECHA "Guidance on the Application of the CLP Criteria" version 5.0, July 2017 in chapter 3.1.5.1.3 Example 3: Since at a dose of 200 mg/kg bw. no mortality and only slight transient symptoms without necropsy findings were observed, at the next dose 2000 mg/kg bw in the range finder study 1 male and 1 female died (all animals) , based on expert judgement it can be assumed that the likely LD50 is > 300 mg/kg bw.
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 200 mg/kg but less than 2000 mg/kg bodyweight.
- Executive summary:
In an acute, GLP compliant oral toxicity study according to OECD guideline 401, 5 male and 5 female Sprague-Dawley CD rats were treated with a single oral gavage dose of 200 mg/kg bw. This dose was chosen based on a previous dose range finding test with 25, 200 and 2000 mg/kg bw (1 male and 1 female per dose) where all animals at 2000 mg/kg bw died. Rats at 200 mg/kg bw showed lethargy and/or hunched posture during the day of dosing. All animals recovered one day after dosing. Animals dosed with 2000 mg/kg bw showed hunched posture, Iethargy, ataxia, decreased respiratory rate, ptosis and pilo-erection. Based on the data, the acute oral median lethal dose (LD50) of the test material in the rat was found to be greater than 200 mg/kg but less than 2000 mg/kg bodyweight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 200 - < 2 000 mg/kg bw
- Quality of whole database:
- Reliable without restrictions
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity, rat, RL1
In an acute, GLP compliant oral toxicity study according to OECD guideline 401, 5 male and 5 female Sprague-Dawley CD rats were treated with a single oral gavage dose of 200 mg/kg bw. This dose was chosen based on a previous dose range finding test with 25, 200 and 2000 mg/kg bw (1 male and 1 female per dose) where all animals at 2000 mg/kg bw died. Rats at 200 mg/kg bw showed lethargy and/or hunched posture during the day of dosing. All animals recovered one day after dosing. Animals dosed with 2000 mg/kg bw showed hunched posture, Iethargy, ataxia, decreased respiratory rate, ptosis and pilo-erection. Based on the data, the acute oral median lethal dose (LD50) of the test material in the rat was found to be greater than 200 mg/kg but less than 2000 mg/kg bodyweight.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Thus, the test item is concluded to be classified for acute oral toxicity (category 4) under Regulation (EC) No 1272/2008, as amended for fifteenth time in Regulation (EU) No 2020/1182.
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.