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EC number: 860-352-3 | CAS number: 1610350-91-8
- 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 an acute oral feeding study in rats according to OECD guideline 420, the acute median lethal oral dose (LD50) of the test item was demonstrated to be greater than 2000 mg/kg body weight (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:
- 2020-04-16 to 2020-06-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- adopted 2001-12-17
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- 2008-05-30
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V., Inc, Postbus 6174, 5960 AD Horst / The Netherlands
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 193.6 g - 229.9 g
- Fasting period before study: Overnight
- Housing: Groups of one to five rats (of the same sex and dose group) were housed in akrolon Type IV cages with wire mesh top and granulated soft wood bedding.
- Diet: Ad libitum (except for overnight fasting prior to dosing; diet was returned immediately after dosing was complete)
- Water: Ad libitum
- Acclimation period: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 45-65 (22-65 for several hours)
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From day 0 to day 14 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL in sterile water
- Amount of vehicle: 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- Pre-experiment: 300 mg/kg bw (1 animal) and 2000 mg/kg bw (1 animal);
Main experiment: 2000 mg/kg bw (4 animals) - No. of animals per sex per dose:
- Pre-experiment: 300 mg/kg bw (1 female) and 2000 mg/kg bw (1 female);
Main experiment: 2000 mg/kg bw (4 females) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Morbidity / Mortality: At least three times within the first six hours after application, thereafter at least once daily for 14 days.
Body weight: On Day 0 (prior to dosing), Day 7, and 14, or (if applicable) at death (unscheduled).
- Necropsy of survivors performed: Yes
- Clinical signs including body weight: Clinical signs and body weight development were monitored in all animals during the study.
- Other examinations performed: Clinical signs, body weight,organ weights, histopathology - Statistics:
- Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test item was made.
- Preliminary study:
- Doses of 300 mg/kg bw (1 animal) and 2000 mg/kg bw (1 animal) were tested in a preliminary study. Following results were obtained:
Mortality: There were no deaths during the study.
Clinical Signs: There were no clinical signs of reaction to treatment throughout the study.
Body Weights: The animal showed expected gains in body weight over the observation period.
Necropsy: Macroscopic examination at study termination on Day 14 revealed an empty stomach (both animals). - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- other: There were no clinical signs of reaction to treatment throughout the study.
- Gross pathology:
- Macroscopic examination at study termination on Day 14 revealed unspecific results, i.e., an empty stomach in one animal, a slightly enlarged heart in one animal, and a slight hypotrophy of the kidney in one animal. No abnormalities were noted in any other animal at the macroscopic examination.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of the test item was demonstrated to be greater than 2000 mg/kg body weight.
- Executive summary:
The study was performed to assess the acute oral toxicity of the test item to the rat.
Following a sighting test at dose levels of 300 mg/kg b.w. and 2000 mg/kg b.w. in one female rat per dose group, a further group of four fasted females was given a single oral dose of the test item, as a solution in sterile water, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored in all animals during the study. All animals were subjected to gross necropsy.
Mortality: There were no deaths.
Clinical Observations: There were no signs of systemic toxicity noted.
Body Weight: All animals showed expected gains in body weight.
Necropsy: Only unspecific results, i.e., a slightly enlarged heart and minor hypotrophy of the kidney were observed in one animal each (both treated with a dose level of 2000 mg/kg b.w.). Two animals (the animal treated with 300 mg/kg b.w. and one animal treated with 2000 mg/kg b.w.) showed an empty stomach.
Reference
Table 1: Individual Clinical Observations and Mortality Data – 300 mg/kg Dose Level mg/kg
Dose Level mg/kg
| Animal Number and Sex | Effects Noted After Dosing (Hours) |
Effects Noted During Period After Dosing (Days) | ||||||||||||||||
½ | 1 | 2 | 5-6 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | ||
300 | Female 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
0= No signs of systemic toxicity
Table 2: Individual Body Weights and Body Weight Changes – 300 mg/kg
Dose Level mg/kg
| Animal Number and Sex | Body Weight (g) at Day | Body Weight Gain (g) During Week | Body Weight Gain (g) During Week | ||||
0 | 7 | 14 | 1
| 2 | 1 | 2 | ||
300 | Female 1 | 193.6 | 215.1 | 232.0 | 21.5 | 16.9
| 11.1 | 7.9 |
Table 3: Individual Necropsy Findings – 300 mg/kg b.w.
Dose Level mg/kg | Animal Number and Sex | Time of Death | MacroscopicObservations |
300 | Female 1 | Euthanatized Day 14 | Empty stomach |
Table 4: Individual Clinical Observations and Mortality Data – 2000 mg/kg
Dose Level mg/kg
| Animal Number and Sex | Effects Noted After Dosing (Hours) |
Effects Noted During Period After Dosing (Days) | ||||||||||||||||
½ | 1 | 2 | 5-6 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | ||
2000 | Female 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Female 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Female 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Female 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Female 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
0= No signs of systemic toxicity
Table 5: Individual Body Weights and Body Weight Changes – 2000 mg/kg b.w.
Dose Level mg/kg
| Animal Number and Sex | Body Weight (g) at Day | Body Weight Gain (g) During Week | Body Weight Gain (g) During Week | ||||
0 | 7 | 14 | 1
| 2 | 1 | 2 | ||
2000 | Female 1 | 208.3 | 232.9 | 248.8 | 24.6 | 15.9 | 11.8 | 6.8 |
Female 2 | 215.7 | 248.0 | 254.8 | 32.3 | 6.8 | 15.0 | 2.7 | |
Female 3 | 222.7 | 246.5 | 258.6 | 23.8 | 12.1 | 10.7 | 4.9 | |
Female 4 | 217.5 | 231.6 | 249.1 | 14.1 | 17.5 | 6.5 | 7.6 | |
Female 5 | 229.9 | 260.0 | 271.8 | 30.1 | 11.8 | 13.1 | 4.5 |
Table 6: Individual Necropsy Findings – 2000 mg/kg b.w.
Dose Level mg/kg | Animal Number and Sex | Time of Death | MacroscopicObservations |
2000 | Female 1 | Euthanatized Day 14 | Empty stomach |
Female 2 | Euthanatized Day 14 | No abnormalities detected | |
Female 3 | Euthanatized Day 14 | Slight hypotrophy of left kidney | |
Female 4 | Euthanatized Day 14 | No abnormalities detected | |
Female 5 | Euthanatized Day 14 | Slightly enlarged heart |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- 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
The study was performed to assess the acute oral toxicity of the test item to the rat. Following a sighting test at dose levels of 300 mg/kg b.w. and 2000 mg/kg b.w. in one female rat per dose group, a further group of four fasted females was given a single oral dose of the test item, as a solution in sterile water, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored in all animals during the study. All animals were subjected to gross necropsy.
Mortality: There were no deaths.
Clinical Observations: There were no signs of systemic toxicity noted.
Body Weight: All animals showed expected gains in body weight.
Necropsy: Only unspecific results, i.e., a slightly enlarged heart and minor hypotrophy of the kidney were observed in one animal each (both treated with a dose level of 2000 mg/kg b.w.). Two animals (the animal treated with 300 mg/kg b.w. and one animal treated with 2000 mg/kg b.w.) showed an empty stomach.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Thus, the test item is considered not to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for fifteenth time in Regulation (EU) No 2020/217.
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