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EC number: 807-747-9 | CAS number: 144429-84-5
- 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 test article caused no mortality in rats upon single oral or dermal exposure to 2000 mg/kg bw. The same is true for the structurally related analogue.
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:
- November 23, 2017 - January 31, 2018
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation:
- Fasting period before study: 16 hours before administration, but water was available ad libitum
- Housing: Single housing, Makrolon cage, type III
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.1 mg/kg bw
DOSAGE PREPARATION (if unusual): The homogeneity of the test item during administration was ensured by stirring with a magnetic stirrer. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females in two groups (6 animals total)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation. Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter. A check for any dead or moribund animals was made at least once each workday.
- Necropsy of survivors performed: Necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with gradually increasing concentrations. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred in both 2000 mg/kg bw test groups.
- Clinical signs:
- other: In all animals of the first 2000 mg/kg bw test group impaired general state and piloerection were observed from hour 3 until hour 5 after administration. In two animals of the second test group impaired general state and piloerection were observed from ho
- Gross pathology:
- There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period (6 females).
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the median lethal dose of the test material after oral administration was found to be greater than 2000 mg/kg bw in rats.
- Executive summary:
In an acute oral toxicity study performed according to the Acute Toxic Class Method, a dose of 2000 mg/kg bw of the undiluted test item was administered by gavage to two test groups of three fasted Wistar rats each (6 females). No mortality occurred. Impaired general state and piloerection was observed in all animals of the first test group and in two animals of the second test group. The body weights of all animals in both 2000 mg/kg bw test groups increased within the normal range throughout the study period. There were no macroscopic pathological findings in any animal sacrificed at the end of observation period (6 females). The acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 22, 1989 to July 17, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: bred and raisedon the premises of CIBA-GEIGY Ltd (CIBA-GEIGY Ltd, Animal Production, 4332 Stein, Switzerland)
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 177-213 g
- Fasting period before study: over night
- Housing: 5 animals per cage (segregated by sex) in Macrolon cages type 4, with standardized soft wood bedding (Société Parisienne des Sciures, Pantin, France)
- Diet: Rat chow (NAFAG 890 Tox, NAFAG, Gossau/SG, Switerzland) ad libitum
- Water: ad libitum
- Acclimation period: at 5 days before administration
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity: 55 +/- 10%
- Air changes: approximately 15 air changes per hour
- Photoperiod: 12h / 12h - Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80
- Doses:
- 2000 mg/kg bw (application volume was 10 mL/kg bw)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days.
Signs and symptoms: daily.
Body weight: immediately before administration and on days 7 and 14.
Necropsies: The animals were sacrificed and submitted to a gross necropsy at the end of the observation period. - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortalities occurred. Common clinical symptoms including piloerection, hunched posture, and dyspnea were seen; the animals recovered within 6 days. Body weight was inconspicuous, Necropsy revealed no abnormalities.
- Mortality:
- None.
- Clinical signs:
- other: Piloerection, hunched posture, and dyspnea were seen (common symptoms in acute tests). The animals recovered within 6 days.
- Gross pathology:
- At necropsy, no deviations from normal morphology were found.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Upon an acute oral administration and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated, where possible) was determined in rats of both sexes: greater than 2000 mg/kg body weight.
- Executive summary:
Sprague-Dawley rats of both sexes were treated by single gavage with 2000 mg/kg bw according to the OECD TG 401 (1987); treatment was followed by a 14 day post-treatment observation; at the end of this period the animals were sacrificed for the purpose of necropsy. No mortalities occurred. Common clinical symptoms including piloerection, hunched posture, and dyspnea were seen; the animals recovered within 6 days. Body weight was inconspicuous, Necropsy revealed no abnormalities. The LD50 for both sexes was > 2000 mg/kg bw.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Study performed according to OECD guideline and GLP.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 6, 1989 to August 1, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: bred and raised on the premises (CIBA-GEIGY Ltd, Animal Production, 4332 Stein, Switzerland)
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 215 to 249 g
- Housing: individually housed in Macrolon cages type 3 with standardized soft wood bedding (Société Parisienne des Sciures, Pantin, France)
- Diet: Rat chow (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) ad libitum
- Water: water ad libitum
- Acclimation period: at least 5 days before exposure
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/ -2°C
- Humidity: 55 +/- 10%
- Air changes: approximately 15 air changes per hour
- Photoperiod: 12h / 12h - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Approximately 24 hours before treatment an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper.
The required amount of the test substance was evenly dispersed on the skin (single application at 2000 mg/kg bw). It was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage.
After an exposure period of 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the skin reaction was appraised repeatedly. - Duration of exposure:
- Single exposure, 24 hours.
- Doses:
- 2000 mg/kg bw.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: daily
Body weight: immediately before application and on days 7 and 14
Necropsies: The animals were sacrificed and submitted to a gross necropsy at the end of the observation period. - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortalities occurred. Common clinical symptoms including piloerection, hunched posture, and dyspnea were seen; the animals recovered within 5 to 7 days. Body weight was inconspicuous, Necropsy revealed no abnormalities
- Mortality:
- None.
- Clinical signs:
- other: Piloerection, abnormal body positions, and dyspnea were seen (common symptoms in acute tests). The animals recovered within 5 to 7 days.
- Gross pathology:
- At autopsy, no deviations from normal morphology were found.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Upon an acute dermal administration and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated, where possible) was determined for both sexes: greater than 2000 mg/kg body weight.
- Executive summary:
Sprague-Dawley rats of both sexes were treated by single dermal application of 2000 mg/kg bw under semiocclusive conditions according to the OECD TG 402 (1987); treatment was followed by a 14 day post-treatment observation; at the end of this period the animals were sacrificed for the purpose of necropsy. No mortalities occurred. Common clinical symptoms including piloerection, hunched posture, and dyspnea were seen; the animals recovered within 5 to 7 days. Body weight was inconspicuous, Necropsy revealed no abnormalities. The LD50 for both sexes was > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Study performed according to OECD guideline and GLP.
Additional information
Acute oral toxicity
Acute oral toxicity was tested by gavage application of 2000 mg/kg bw to two groups of 3 female rats. No mortalities occurred. In all animals of the first 2000 mg/kg bw test group impaired general state and piloerection were observed from hour 3 until hour 5 after administration. In two animals of the second test group impaired general state and piloerection were observed from hour 3 until hour 4 after administration. The body weights of all animals in both 2000 mg/kg bw test groups increased within the normal range throughout the study period. There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period (6 females). Under the conditions of this study the median lethal dose of XPDL 920 after oral administration was found to be greater than 2000 mg/kg bw in rats.
Assessment of structural analogue substance (EC 406-040-9)
Acute dermal toxicity
Acute dermal toxicity was tested by semi-occlusive application of 2000 mg/kg bw to rats. No mortalities occurred. Common clinical symptoms including piloerection, hunched posture, and dyspnea were seen; the animals recovered within 5 to 7 days. Body weight was inconspicuous, Necropsy revealed no abnormalities. The study was performed under GLP and according to OECD testing guideline 402.
The substance is a viscous, non volalite liquid. Therefore, inhalation testing was not performed.
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. The LD50 of
a structual analogue substance was greater than 2000 mg/kg bw. As a
result the substance is not considered to be classified for acute oral
or dermal toxicity under Regulation (EC) No 1272/2008, as amended for
the eighth time Regulation
(EU) No 2016/218.
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