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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 208-798-4 | CAS number: 542-08-5
- 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 LD50 for acute oral toxicity of the test item in rats was determined to be greater than 2000 mg/kg bw (reference 7.2.1-1).
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:
- 1988-01-13 to 1988-02-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987-02-24
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 1984-04-25
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG
- Females nulliparous and non-pregnant: not detailed
- Rationale for use of males: according to guideline followed for a limit test each 5 females and 5 males should be used
- Age at study initiation: female: ca. 7 weeks, males: ca. 8 weeks
- Weight at study initiation: female: 190 ± 2.1 g, males: 201 ± 7.7 g
- Fasting period before study: yes, ca. 16 h before study; additionally 3-4 h after application
- Housing: 5 animals per cage, Makrolon cages Typ 4 with wooden bedding
- Diet: ad libitum, rat diet Altromin 1324
- Water: ad libitum, tap water
- Acclimation period: at least 5 days
- Microbiological status when known
- Method of randomisation in assigning animals to test and control groups: accoring to schedule 931/87 and 1399/87
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): not detailed, but air condition in animal rooms
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil (Oleum Sesami)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 %
- Amount of vehicle: 10 mL/kg bw - Doses:
- 2000 mg/kg bw
- 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: observation: after 10, 30 min, 1, 2, 4, 6 h and afterwards once per day; weighing: once per week
- Necropsy of survivors performed: yes
- Examinations performed: clinical signs, body weight, macroscopic changes - Statistics:
- no details provided
- Preliminary study:
- A preliminary study was performed with the test item at a concentration of 10 % in sesame oil. Doses of 500, 1000 and 2000 mg/kg bw were administered to each one female and male animal per dose group. They were observed for 14 days and body weight was recorded. All animals showed general signs of toxicity and difficulties with breathing. An increase of body weight was observed in all animals independent on dose group. All animals were sacrificed after observation period and no macroscopic changes were detected.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Crouched position, retracted flanks, stalked and uncoordinated movement and uneven breathing were observed in animals of both sexes in the first hours and the first day after treatment. Starting from the second day after treatment no clinicals signs were
- Gross pathology:
- No macroscopic changes were detected.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral toxicity LD50 of the test item was greater than 2000 mg/kg bw in rats.
- Executive summary:
The acute oral toxicity of the test item was assessed in a study according to OECD 401 in rats. Animals of both sexes, each 5, were treated with 2000 mg/kg bw by gavage. Afterwards animals were observed for 14 days. During this time no animals died and the body weight gain was not affected by treatment. The animals showed signs of toxicity such as crouched position, retracted flanks, stalked and uncoordinated movement and uneven breathing in the first hours and on the first day after treatment. From the second day after treatment onwards no clinical signs were observed. Macroscopic examination after sacrifice at the end of the observation period showed no changes. Based on the results of the study the LD50 for acute oral toxicity was determined to be greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study was conducted according to guideline and therefore is considered as reliable.
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 acute oral toxicity of the test item was assessed in a study according to OECD 401 in rats. Animals of both sexes, each 5, were treated with 2000 mg/kg bw by gavage. Afterwards animals were observed for 14 days. During this time no animals died and the body weight gain was not affected by treatment. The animals showed signs of toxicity such as crouched position, retracted flanks, stalked and uncoordinated movement and uneven breathing in the first hours and on the first day after treatment. From the second day after treatment onwards no clinical signs were observed. Macroscopic examination after sacrifice at the end of the observation period showed no changes. Based on the results of the study the LD50 for acute oral toxicity was determined to be greater than 2000 mg/kg bw.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on acute toxicity, the test item does not require
classification for acute toxicity via the oral route according to
Regulation (EC) No 1272/2008 (CLP), as
amended for the fifteenth time in Regulation (EU) 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.