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EC number: 685-617-9 | CAS number: 1099648-69-7
- 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
Oral LD50 > 2000 mg/kg bw (OECD 423, K, Rel.2, class method in 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:
- 25 March to 09 April 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 423 without any deviation. However, the isomers ratio is not reported.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- Directive n° 2004/73/EC.
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2007-01-11 / Signed on 2007-02-21.
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Test item was considered at 100% for the study.
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle – France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 195-207 g
- Fasting period before study: Food was removed at Day 1 and then redistributed 4 h after the test item administration.
- Housing: Animals were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet, ad libitum
- Water: Drinking water (tap-water from public distribution system), ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-24 °C
- Humidity: 42-60 %
- Air changes: at least ten changes per hour
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: 25 March to 09 April 2008 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- TEST SUBSTANCE ADMINISTRATION
- Test substance was administered by gavage under a volume of 2.06 mL/kg bw using a suitable syringe graduated fitted with an oesophageal metal canula.
MAXIMUM DOSE VOLUME APPLIED: 2.06 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females/dose
- Control animals:
- yes
- Remarks:
- control animals received distilled water at 2 mL/kg bw
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 14 days after administration of the test item. Observations and a mortality report were then carried out every day for 14 days. Animals were weighed on Day 0 (just before administering the test item) then on Days 2, 7 and 14.
- Necropsy of survivors performed: Yes; On Day 14, the animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels, then animals were subjected to macroscopic observations. - Statistics:
- None
- Preliminary study:
- None
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- It was noted the death of 1 treated rat, 24 hours after the test item administration.
- Clinical signs:
- A decrease of the spontaneous activity (6/6) associated with a bradypnea (3/6), an absence of Preyer’s reflex (2/6), eyes partly or completely closed (2/6) and an absence or a decrease of righting reflex (4/6) was registered during the 1st day of the test. The animals recovered a normal activity the 2nd day of the test.
- Body weight:
- The body weight evolution of the animals remained normal throughout the study.
- Gross pathology:
- The macroscopical examination of the animal which died during the study revealed the presence of red foci on the corpus and the lungs and a thinning of the forestomach.
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. - Other findings:
- None
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the test conditions, the oral LD50 for test substance is higher than 2000 mg/kg bw and the LD50 cut-off is 2500 mg/kg bw in female rats. Therefore the test substance is not classified according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and classified in category 5 according to the GHS.
- Executive summary:
In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, 6 female Sprague Dawley rats were given a single oral (gavage) dose of test substance at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.
It was noted the death of 1 treated rat, 24 hours after the test item administration. A decrease of the spontaneous activity (6/6) associated with a bradypnea (3/6), an absence of Preyer’s reflex (2/6), eyes partly or completely closed (2/6) and an absence or a decrease of righting reflex (4/6) was registered during the 1st day of the test. The animals recovered a normal activity the 2nd day of the test. The body weight evolution of the animals remained normal throughout the study. The macroscopical examination of the animal which died during the study revealed the presence of red foci on the corpus and the lungs and a thinning of the forestomach. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In this study, the oral LD50 for test substance was considered to be higher than 2000 mg/kg bw in female rats.
Under the test conditions, the oral LD50 for test substance is higher than 2000 mg/kg bw and the LD50 cut-off is 2500 mg/kg bw in female rats. Therefore the test substance is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and classified in category 5 (H303) according to the GHS.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 500 mg/kg bw
- Quality of whole database:
- The key study is GLP compliant and of high quality. However, the isomers are not adequately characterised and as such the reliability of the study was reduced.
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
A key study was identified (Phycher, 2008, rel. 2). In this acute oral toxic class method study performed according to the OECD guideline No. 423 and in compliance with GLP, six fasted female Sprague Dawley rats received a single oral (gavage) dose of the test substance at a dose level of 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.
It was noted the death of 1 treated rat, 24 hours after the test item administration. A decrease of the spontaneous activity (6/6) associated with a bradypnea (3/6), an absence of Preyer’s reflex (2/6), eyes partly or completely closed (2/6) and an absence or a decrease of righting reflex (4/6) was registered during the 1st day of the test. The animals recovered a normal activity the 2nd day of the test. The body weight evolution of the animals remained normal throughout the study. The macroscopical examination of the animal which died during the study revealed the presence of red foci on the corpus and the lungs and a thinning of the forestomach. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Oral LD50 > 2000 mg/kg bw and the LD50 cut-off is 2500 mg/kg bw
Justification for classification or non-classification
Harmonised classification:
The substance has no harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP).
Self classification:
Acute toxicity (Oral):
Based on the available information, the substance is:
- not classified according to the CLP as the oral LD50 is higher than 2000 mg/kg bw
- classified according to the GHS into Category 5 as the LD50 cut-off is 2500 mg/kg bw.
Acute toxicity (Dermal):
No information was available. Not required for substances at the REACH Annex VII tonnage level.
Acute toxicity (Inhalation):
No information was available. Not required for substances at the REACH Annex VII tonnage level.
Specific target organ toxicity: single exposure (Oral):
The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification is required.
The criteria for Transient Organ effects (STOT-SE Category 3 / Narcotic effects) according to Annex VI of the Regulation (EC) No. 1272/2008 are not met since narcotic effects were not observed in the acute oral toxicity study.
Specific target organ toxicity: single exposure (Dermal):
No information was available. Not required for substances at the REACH Annex VII tonnage level.
Specific target organ toxicity: single exposure (Inhalation):
No information was available. Not required for substances at the REACH Annex VII tonnage level.
Aspiration hazard:
The substance is not a hydrocarbon and no effects were observed on lungs in oral studies, therefore the criteria for aspiration toxicity according to the CLP and to the GHS are not met.
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