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EC number: 812-907-6 | CAS number: 34989-82-7
- 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
In the acute oral toxicity study with rats a LD50 > 2000 mg/kg bw was determined.
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:
- 2016-10-25 to 2016-11-10
- 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:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Lot: 216-106
- Expiry date: 2018-06-16
- Storage conditions: Keep at room temperature - Species:
- rat
- Strain:
- other: Crl:WI
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxi-Coop Zrt. 1103 Budapest
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 11 weeks
- Weight at study initiation: 227-234 g (first group), 214-220 g (second group)
- Fasting period before study: on day before treatment
- Housing: 3 animals/sex/cage
- Diet: ad libitum, ssniff® SM R/M-Z+H complete diet
- Water: ad libitum, tap water
- Acclimation period: 26 days in first group and 27 days in second group
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): above 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION:
Formulations were prepared just before the administration and stirred continuously during the treatment.
CLASS METHOD
- Rationale for the selection of the starting dose:
The starting dose was selected on the basis of the available information about the test item. A limit test was performed. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 (3 in first and 3 in second group)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually after dosing once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h, after the treatment and once per day for 14 days thereafter. The body weight were recorded on day 0 (shortly before the treatment), on day 7 and on day 15 on all animals.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- No statistical analysis was performed.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The test item did not induce mortality following a single oral administration to female rats at a dose of 2000 mg/kg bw. All rats isurvived until the end of the 14-day observation period.
- Clinical signs:
- other: Animals showed following clinical signs: decreased activity, tremor, abnormal gait, limb position, incoordination, bedding chewing, closed eyes, piloerection and clonic convulsion. These symptoms were observed between 30 minutes and Day 2 after the treatm
- Gross pathology:
- No pathological changes were found related to the test item during the macroscopic examination of animals.
- Other findings:
- - Other observations: No.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the acute oral toxicity study with rats a LD50 > 2000 mg/kg bw was determined.
- Executive summary:
An acute oral toxicity study was carried out using the acute toxic class method according to OECD guideline 423. The method was conducted using a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level, so three further female rats were treated with the same dose. No animal died in the second step, therefore no further testing was required. Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out on the 15th day after the treatment. No lethality was noted following oral administration of a single dose of 2000 mg/kg bw. In the first step at a dose level of 2000 mg/kg bw, CNS - and emotion symptoms (decreased activity, tremor, bedding chewing, closed eyes, clonic convulsion), disturbances of the coordination (abnormal gait, limb position, incoordination) and disturbance of the autonomic functions (piloerection) were observed in animals on the treatment day between 30 minutes and 4 hours after the treatment. In the second step at a dose level of 2000 mg/kg bw, similar CNS - and emotion were observed in animals between 30 minutes and Day 2 after the treatment. Those temporary effects were considered to be test item related. Body weight gain backwardness was observed in one female in the second week. It was evaluated as an individual variation without toxicological meaning of the test item. All animals survived until the scheduled autopsy on Day 15. All organs of all animals proved to be free of gross pathological changes. For this acute oral toxicity study with the test item in rats the determined LD50 is above 2000 mg/kg bw. Therefore the test substance is not classified for acute oral toxicity according to CLP (EU-GHS).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP-conform study according to OECD guideline.
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
Acute oral toxicity
An acute oral toxicity study was carried out using the acute toxic class method according to OECD guideline 423. The method was conducted using a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level, so three further female rats were treated with the same dose. No animal died in the second step, therefore no further testing was required. Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out on the 15th day after the treatment. No lethality was noted following oral administration of a single dose of 2000 mg/kg bw. In the first step at a dose level of 2000 mg/kg bw, CNS - and emotion symptoms (decreased activity, tremor, bedding chewing, closed eyes, clonic convulsion), disturbances of the coordination (abnormal gait, limb position, incoordination) and disturbance of the autonomic functions (piloerection) were observed in animals on the treatment day between 30 minutes and 4 hours after the treatment. In the second step at a dose level of 2000 mg/kg bw, similar CNS - and emotion were observed in animals between 30 minutes and Day 2 after the treatment. Those temporary effects were considered to be test item related. Body weight gain backwardness was observed in one female in the second week. It was evaluated as an individual variation without toxicological meaning of the test item. All animals survived until the scheduled autopsy on Day 15. All organs of all animals proved to be free of gross pathological changes. For this acute oral toxicity study with the test item in rats the determined LD50 is above 2000 mg/kg bw. Therefore the test substance is not classified for acute oral toxicity according to CLP (EU-GHS).
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
Based on available data on acute toxicity via oral route, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the ninth time in Regulation (EU) No 2016/1179.
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