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Diss Factsheets
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EC number: 908-820-9 | 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
Endpoint summary
Administrative data
Description of key information
The LD50 of the available fully reliable acute oral toxicity study (according to OECD 401) was derived at 385 mg/kg bw.
Additionally, information from TSCA 8e section provides an LC50 of ca. 4410 ppm.
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:
- other: study was performed prior to OECD guideline and GLP but follows principles thereof.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- prior to GLP requirements
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Bor: WISW (SPF TNO)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Weight at study initiation: male: 145 g, female 121 g
- Fasting period before study: 16h
- Housing: 1-5 animals per cage
- Diet (e.g. ad libitum): R10, Ssniff
- Water: libitum
- Acclimation period: 4-8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 1°C
- Humidity (%): 60 +- 5%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- petrolatum
- Details on oral exposure:
- VEHICLE
details not given
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
- Doses:
- 251, 316, 398, 501, 631 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: clinical signs up to 6h and then daily body weight day 1, 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight: - Statistics:
- LD50 determination according to Litchfield and Wilcoxon, 95% confidence interval
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 385 mg/kg bw
- 95% CL:
- 324 - 488
- Mortality:
- males/females (out of 5)
251 mg/kg bw: 0/0
316 mg/kg bw: 1/0
398 mg/kg bw: 3/3
501 mg/kg bw: 4/5
631 mg/kg bw: 5/5
Death occurred within 24-48 hours post application - Clinical signs:
- other: No macroscopic changes were seen at necropsy. Clinical symptoms included diarrhoea, ataxia, staggered gait, hunched posture, sedation. Up to ten days after treatment the animals showed signs of intoxication.
- Gross pathology:
- dead animals showed reddened mucosa in the stomach and gut, all other animals showed no signs.
- Other findings:
- - Potential target organs: CNS
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Under conditions tested, the LD50 of the test substance was calculated to be 385 mg/kg body weight. Mortality is considered to be mainly due to its corrosive properties, however, clinical signs may be indicative of possible neurotoxicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 385 mg/kg bw
- Quality of whole database:
- reliable without restriction
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Information from TSCA 8e section; no full report in hand but result has impact on hazardous properties and classification and labelling of test material
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 16.3 mg/L air (analytical)
- Other findings:
- - Potential target organs: CNS
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- 2/6 animals died in the 2990 ppm group, 3/6 in the 4410 ppm and 5/6 in the 6290 ppm group. (LC50 ca. 4410 ppm)
Clinical signs: Impairment of startle response from 359 ppm. At 2990 and 4410 ppm abnormal gait, impaired mobility, changes in arousal, hunched posture, irregular respiration. Approximate LC50 in mg/l: 4410 ppm * 90.55/24.45 * 1000 = 16.3 mg/l
Reference
2/6 animals died in the 2990 ppm group, 3/6 in the 4410 ppm and 5/6 in the 6290 ppm group. (LC50 ca. 4410 ppm) Clinical signs: Impairment of startle response from 359 ppm. At 2990 and 4410 ppm abnormal gait, impaired mobility, changes in arousal, hunched posture, irregular respiration. Approximate LC50 in mg/l: 4410 ppm * 90.55/24.45 * 1000 = 16.3 mg/l
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 4 410 ppm air
- Quality of whole database:
- abstract information from TSCA 8e
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the results obtained the submission substance has to be classified as acute orally toxic and toxic by inhalation Cat. 4 according to Regulation (EC) No. 1272/2008 (CLP).
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.
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