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EC number: 205-377-7 | CAS number: 139-85-5
- 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
Acute oral toxicity: Key study. Test method according to OECD 423, GLP study. The LD50 of the test item is higher than 300 mg/kg and lower than 2000 mg/ kg body weight by oral route in the rat. Therefore test item has to be classified in Category 4 in accordance with the Regulation EC No. 1272/2008.
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:
- 19 July to 16 August 2022
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (F-69210 Saint-Germain-Nuelles)
- Females: 9
- Age at study initiation: 8 weeks
- Period before study: 5 days.
- Housing: housed bu group of three in solid-bottomed clear polycarbonate cages with a stainless-steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air-conditioned animal husbandry.
- Diet (e.g. ad libitum): removed on Day 1 and then redistributed 4 hous after the test item administration.
- Water (e.g. ad libitum): Ad libitum. Drinking water (tap-water from public distribution system).
- Acclimation period: the animals were acclimatized for at least 5 days before treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19ºC to 25ºC
- Humidity (%): 30 to 70%
- Air changes (per hr): ≥ 10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light (07.00 to 19.00) and 12 hours dark cycle. - Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- The test item was used after being diluted in DMSO.
DMSO (vehicle) was chosen as it produced the most suitable formulation at the requested dose of 300 mg/kg body weight. - Doses:
- 2000 mg/kg and 300 mg/kg
- No. of animals per sex per dose:
- 2000 mg/kg (3 female rats) and 300 mg/kg (6 female rats)
- Control animals:
- yes
- Remarks:
- Study performed on three animals receiving DMSO under requirements of OECD Guideline 423.
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed in day 0, 2, 7 and 14.
- Necropsy of survivors performed: yes.
- Clinical signs including body weight: spontaneous activity, Preyer’s reflex (noise), respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex, back hair appearance. The body weight evolution of animals treated with the test item was compared with the body weight evolution of the control group.
- Other examinations performed: Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. No organ was removed and preserved in view to microscopic examinations. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 2 mortalities were noted in animals treated at the dose of 2000 mg/kg body weightt 1 hour after the treatment. No mortality was noted in animals treated at the dose of 300 mg/kg body weight
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- Group treated at 2000 mg/kg and group treated at 300 mg/kg body weight remained normal
- Gross pathology:
- - Group treated at 2000 mg/kg: in ded animals the macroscopic examination of the animals revealed a rigor mortis, wet hairs on the muzzle, a stomach filled with air, a thin proventricular wall, a brown/orange and thick fundic mucosa with red areas and a brown and a thin fundic mucosa with red areas. In the surving ones, the macroscopic examination did not reveal any treatment related changes.
- Group treated at 300 mg/kg: the macroscopic examination of the animals at the end of the study evealed a thinning of the proventricular well in two animals - Interpretation of results:
- other: Category 4 (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The LD50 of the test item is higher than 300 mg/ kg body weight and lower than 2000 mg/kg body weight by oral route in the rat.
- Executive summary:
The acute oral toxicity of the test item has been tested in accordance with OECD Test Guideline 423, following GLP. 9 female Sprague-Dawley rats were administered by oral gavage in 3 steps with test item diluted in vehicle DMSO.
The study was performed with 3 female rats at 2000 mg/kg (Step 1), with 3 female rats at 300 mg/kg (Step 2) and with 3 female rats at 300 mg/Kg (Step 3).
In group treated at 2000 mg/kg, two mortalities were noted in animals treated at the dose of 2000 mg/kg weight 1 hout after the treatment. the body weight of the animal remained normal during study. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
In group treated at 300 mg/kg, no mortality was noted in animals. The body weight of the animal remained normal during study. The macrscopis examination of the niamals at the end of the study revealed a thinning of the proventricular well in two animals.
Based on these results, the LD50 of the test item is determined to be higher than 300 mg/kg and lower than 2000 mg/ kg bw by oral route in the rat.
Reference
FEMALES | D0 | D2 | D2-D0 | D7 | D7-D0 | D14 | D14-D0 |
Rf 6950 | 210 | - | - | - | - | - | - |
Rf 6951 | 207 | 214 | 7 | 264 | 57 | 287 | 80 |
Rf 6952 | 210 | - | - | - | - | - | - |
MEAN | 209.0 | 214.0 | 7.0 | 264.0 | 57.0 | 287.0 | 80.0 |
Standard deviation | 1.7 | - | - | - | - | - | - |
Dose: 2000 mg/kg body weight
D0 | D2 | D2-D0 | D7 | D7-D0 | D14 | D14-D0 | |
Rf 6953 | 210 | 230 | 20 | 251 | 41 | 247 | 37 |
Rf 6954 | 211 | 224 | 13 | 244 | 33 | 240 | 29 |
Rf 6955 | 218 | 244 | 26 | 261 | 43 | 263 | 45 |
Rf 6959 | 180 | 176 | -4 | 180 | 0 | 211 | 31 |
Rf 6960 | 184 | 172 | -12 | 223 | 39 | 238 | 54 |
Rf 6961 | 219 | 192 | -27 | 258 | 39 | 272 | 53 |
MEAN | 203.7 | 206.3 | 2.7 | 236.2 | 32.5 | 245.2 | 41.5 |
Standard deviation | 17.2 | 30.3 | 20.5 | 30.7 | 16.3 | 21.4 | 10.8 |
Dose: 300 mg/kg body weight
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- >= 300 - <= 2 000 mg/kg bw
- Quality of whole database:
- Key study with Klimisch score = 1
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
Justification for classification or non-classification
Based on the available data, the substance is classified as Category 4 for acute toxicity (oral) according to CLP Regulation (EC) no. 1272/2008.
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