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EC number: 846-828-3 | CAS number: 1872341-39-3
- 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 a GLP-compliant acute toxic class method study (according to OECD Guideline 423) the test substance was administered orally by gavage at doses of 300 and 2000 mg/kg bw to groups of 3 female rats, respectively. One animal died in one of the two 2000 mg/kg bw dose groups. No further adverse effects occurred during the observation period of 14 days. The oral LD50 was therefore determined to be > 2000 mg/kg bw for female rats.
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:
- Feb - Mar 2019
- 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:
- December 17, 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesanstalt für Umwelt Baden-Württemberg
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: L2018-137
- Expiration date of the Batch: February 01, 2021
- Purity: 99.6 % (tolerance ± 1 %)
- Physical state / color: solid / yellowish
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was prepared for each test group shortly before administration by stirring with a high-speed homogenizer (Ultra-Turrax) and a magnetic stirrer. The homogeneity of the test item preparation during administration was ensured by stirring with a magnetic stirrer.
FORM AS APPLIED IN THE TEST (if different from that of starting material) : suspension - Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI (Han) SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 9 - 10 weeks
- Weight at study initiation: animals of comparable weight (± 20 % of the mean weight)
- Fasting period before study: feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum
- Housing: single housing
- Diet (e.g. ad libitum): R/M maintenance, low phytoestrogen; Ssniff, Spezialdiäten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany), ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days before administration
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ° C ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- Ph.Eur.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 6 and 40 g/100 mL
- Amount of vehicle (if gavage): 5 mL/kg bw
- Justification for choice of vehicle: good homogeneity of the test substance in corn oil Ph.Eur.
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
DOSAGE PREPARATION (if unusual): The test item was prepared for each test group shortly before administration by stirring with a high-speed homogenizer (Ultra-Turrax) and a magnetic stirrer.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: By request of the sponsor a starting dose of 300 mg/kg bw was chosen in the first step with 3 female animals. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- 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, on the last day of observation and on the day of death starting with study day 1. Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, gross-pathology - Statistics:
- Calculations were performed using Microsoft Excel 2010 and checked with a calculator.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred in either the single 300 mg/kg bw test group or in the second 2000 mg/kg bw test group.
In the first 2000 mg/kg bw test group, one animal was found dead on study day 1. - Clinical signs:
- other: No clinical signs were observed in the first 300 mg/kg bw and the second 2000 mg/kg bw test group during clinical examination. In two animals of the first 2000 mg/kg bw test group reduced defecation was seen on day 1 only. In the other animal of this test
- Gross pathology:
- The following macroscopic pathologic findings were observed in the single animal that died in the first 2000 mg/kg bw test group: dark red spotted discoloration of the liver.
There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period (2000 mg/kg bw: 5 females; 300 mg/kg bw: 3 females). - Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be > 2000 mg/kg bw in rats.
- Executive summary:
In an acute oral toxicity study performed according to the Acute Toxic Class Method, doses of 2000 and 300 mg/kg bw of the test item (preparations in corn oil Ph.Eur.) were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females and 300 mg/kg bw in 3 females).
The following test substance-related clinical observations were recorded, clinical signs occurred within one day after administration:
2000 mg/kg (first test group):
- Mortality in one animal
- Reduced defecation in two animals
- Dyspnoea in one animal
- Staggering in one animal
- Impaired general state in one animal
- Macroscopic pathological findings in the animal that died:
- Dark red spotted discoloration of the liver
2000 mg/kg (second test group):
- No mortality occurred
- No clinical signs were observed
300 mg/kg (single test group):
- No mortality occurred
- No clinical signs were observed.
The body weights of the surviving animals 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 (8 females).
The acute oral LD50 was calculated to be: LD50, oral, rat > 2000 mg/kg bw.
Reference
Table 2: Mortality
Dose [mg/kg bw] |
2000 |
2000 |
300 |
Sex |
Female |
Female |
Female |
Administration |
1 |
2 |
1 |
No. of animals |
3 |
3 |
3 |
Mortality [animals] |
1 |
No mortality |
No mortality |
Table 3: Maximum incidence of clinical signs
Dose [mg/kg bw] |
2000 |
2000 |
300 |
||||||
Sex |
Female |
Female |
Female |
||||||
Administration |
1 |
2 |
1 |
||||||
No. of animals |
3 |
3 |
3 |
||||||
Animal No. |
R 482 |
R 483 |
R 484 |
R 485 |
R 486 |
R 487 |
R 476 |
R 477 |
R 478 |
Abnormalities |
|
|
|
- |
- |
- |
- |
- |
- |
Dyspnoea |
- |
h4 – h5 |
- |
- |
- |
- |
- |
- |
- |
Impaired general state |
- |
h4 – h5 |
- |
- |
- |
- |
- |
- |
- |
Staggering |
- |
h4 – h5 |
- |
- |
- |
- |
- |
- |
- |
Reduced defecation |
d1 |
- |
d1 |
- |
- |
- |
- |
- |
- |
Mortality |
- |
d1 |
- |
- |
- |
- |
- |
- |
- |
h hour
d day
Table 4: Individual body weights
Dose [mg/kg bw] |
2000 |
2000 |
300 |
||||||||||||
Administration |
1 |
2 |
1 |
||||||||||||
Animal No. |
R 482 |
R 483 |
R 484 |
Mean |
SD |
R 485 |
R 486 |
R 487 |
Mean |
SD |
R 476 |
R 477 |
R 478 |
Mean |
SD |
Body weight at study day [g]: 0 1 7 14 |
183 - 200 203 |
183 174 - - |
184 - 196 203 |
183.3 - 198.0 203.0 |
0.58 - 2.83 0.00 |
182 - 201 207 |
185 - 198 210 |
183 - 197 212 |
183.3 - 198.7 209.7 |
1.53 - 2.08 2.52 |
178 - 199 211 |
173 - 199 207 |
174 - 201 208 |
175.0 - 199.7 208.7 |
2.65 - 1.15 2.08 |
SD Standard deviation
Table 5: Gross pathology
Dose [mg/kg bw] |
2000 |
2000 |
300 |
||||||
Administration |
1 |
2 |
1 |
||||||
No. of animals |
3 |
3 |
3 |
||||||
Animal No. |
R 482 |
R 483 |
R 484 |
R 485 |
R 486 |
R 487 |
R 476 |
R 477 |
R478 |
Macroscopic pathologic abnormalities |
- |
Liver: dark red, spotted discolored |
- |
- |
- |
- |
- |
- |
- |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
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
In an acute oral toxicity study performed according to the Acute Toxic Class Method, doses of 2000 and 300 mg/kg bw of the test item (preparations in corn oil Ph.Eur.) were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females and 300 mg/kg bw in 3 females).
The following test substance-related clinical observations were recorded, clinical signs occurred within one day after administration:
2000 mg/kg (first test group):
- Mortality in one animal
- Reduced defecation in two animals
- Dyspnoea in one animal
- Staggering in one animal
- Impaired general state in one animal
- Macroscopic pathological findings in the animal that died:
- Dark red spotted discoloration of the liver
2000 mg/kg (second test group):
- No mortality occurred
- No clinical signs were observed
300 mg/kg (single test group):
- No mortality occurred
- No clinical signs were observed.
The body weights of the surviving animals 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 (8 females).
The acute oral LD50 was calculated to be: LD50, oral, rat > 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 1272/2008. One out of 6 animals died after oral gavage of 2000 mg/kg bw test substance. No further adverse effects were observed in the acute toxic class method study (according to OECD Guideline 423, GLP-compliant). As a result, the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No. 2018/1480.
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