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EC number: 214-160-6 | CAS number: 1103-38-4
- 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
Studies on inhalative acute toxicity of the test item were not performed.
The studies that were performed to evaluate acute oral and inhalative toxicity of the test substance to the rat accorded to OECD guidelines 401 and 403. The test substance did not induce mortalities, abnormalities or clinical signs when applied oral. Also, single administration of the analogue substance via the respiratory system did not cause health effects or mortalities. The LD50 for oral toxicity is considered to be > 5000 mg/kg bw, LC50 is > 5.24 mg/l air.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- insufficient information to animals, enviromental conditions and test substance
- GLP compliance:
- no
- Remarks:
- priot to GLP-introduction
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 5-6 weeks
- Weight (g) at study initiation: 113 male, 109 female
- Fasting period before study: 18h
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Photoperiod (hrs dark / hrs light): 12 - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE (50 % PEG)
- Concentration in vehicle: 17 %
- Amount of vehicle (if gavage): 30 ml
MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: no mortality occurred
- Mortality:
- no mortality
- Clinical signs:
- other: no clinical signs
- Gross pathology:
- no findings
- Other findings:
- The faces were stained red throughout the study.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent
- Age at study initiation: young adult
- Weight at study initiation: males 274 - 324g, females 244- 260g
- Fasting period before study: /
- Housing: groups of five
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 52-67
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: To: / - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: cylindrical exposure chamber with continuous flow
- Exposure chamber volume: 30 l
- Method of holding animals in test chamber: a tapered, polycarbonate restraining tube fitted onto a single tier of the exposure chamber and sealed by means of a rubber '0' ring
- Source and rate of air: compressed air was supplied by means of a Gast oil free compressor
- Method of conditioning air: passed through a water trap and respiratory quality filters which removed particulate material above 0.005 pm before
- System of generating particulates/aerosols: produced from the test material using a 'Wright Dust Feed' mechanism located at the top of the exposure chamber and driven by a variable speed motor. The dust feed was connected to a metered compressed air supply.
- Method of particle size determination: determined three times during the exposure period using a Cascade Impactor
- Temperature, humidity, pressure in air chamber: measured by an electronic thermometer/humidity meter (Kane-May Ltd., Welwyn Garden City, Hertfordshire, U.K.) located in a vacant port in the animals' breathing zone of the chamber and recorded every thirty minutes throughout the four-hour exposure period.
TEST ATMOSPHERE
- Brief description of analytical method used: The chamber was maintained under negative pressure. Homogeneity of the test atmosphere within the chamber was not specifically determined during this study, but, chambers of the same design have been fully validated and shown to produce evenly distributed atmospheres in the animals' breathing zone with a wide variety of test materials. (Green J.D. et al. Fundamental and Applied Toxicology 4, 768 - 777, 1984)
- Samples taken from breathing zone: no
VEHICLE
- air
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: particle size of the generated atmosphere of the test material inside the exposure chamber was determined three times during the exposure period using a Cascade Impactor. This device consisted of six impactor stages with stainless steel collection substrates (10, 6, 3.5, 1.6, 0.9 and 0.5 pm cut-off points) and a back up glass fibre filter. collection substrates were weighed before and after sampling and the weight of test material, collected at each stage, calculated by difference. From the results obtained the weight distribution of particles in the size range > 10 pm, 10 - 6 pm, 6 - 3.5 pm, 3.5 -1.6 pm, 1.6 - 0.9 pm and 0.9 - <0.5 pm was calculated. - Analytical verification of test atmosphere concentrations:
- no
- Remarks:
- concentration estimated at regular intervals during the exposure period, gravimetric method used, employed glass fibre filters (Gelman type A/E 25 mm)
- Duration of exposure:
- ca. 4 h
- Concentrations:
- 5.0 mg/litre
- No. of animals per sex per dose:
- 5 per sex and dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations hourly during exposure, immediately on removal from the restraining tubes at the end of the exposure, one hour after termination of the exposure and subsequently once daily for 14 days, bodyweights were recorded on the day of exposure, days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- Using the mortality data obtained, an estimate of the acute inhalation median lethal concentration (LC50) of the test material was made.
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.24 mg/L air
- Exp. duration:
- 4 h
- Remarks on result:
- other: no mortality occurred
- Mortality:
- no mortalities
- Clinical signs:
- other: During exposure wet fur, decreased respiratory rate and test material staining of the fur were noted. On removal from the chamber animals additionally showed hunched posture, lethargy and pilo-erection. Laboured respiration and ptosis were common and ther
- Body weight:
- Expected bodyweight development was noted throughout the study
- Gross pathology:
- No abnormalities were detected at necropsy
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No deaths occurred in a group of ten rats exposed to a mean achieved concentration of 5.24 mg/litre (range 4.25 - 6.33 mg/litre). It was therefore considered that the acute inhalation median lethal concentration (LC50) of the test material in the Sprague-Dawley strain rat was greater than 5.24 mg/litre.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 5.24 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Procedure and observations
A single dose of 5000 mg/kg bw dissolved in PEG was administrated to a group of 10 rats (5/sex/dose) by gavage (Ciba 1975). After treatment animals were observed for 14d and checked for clinical signs. All animals survived until scheduled necropsy; abnormalities or signs of toxicity were not observed. The feces of the treated animals was red stained throughout the study.
To evaluate the acute inhalative toxicity, male and female rats (5/sex/dose) were exposed for 4h to a dust aerosol of the analogue substance (range 4.25 - 6.33 mg/l air, nose only) (BASF 2010). Following dosing, the animals were observed for 14d. Examination of clinical signs and viability were performed daily, weighing on day 1, 7 and 13 after treatment. There were no deaths as a result of treatment with the test article. Clinical signs of toxicity or changes in body weight gain were not observed during the observation period. Gross necropsy was without any findings.
Discussion
Application of the test substance or an analogue via oral or inhalative route did not induce any signs of toxicity. None of the animals died due to treatment, viability and bodyweight gain were unaffected by the test article. The test item was not tested for acute dermal toxicity. With regard to the physico-chemical properties of the substance (pH, structure, solubility), the very limited skin penetration and the absence of systemic and local effects in acute oral and acute inhalation studies dermal toxicity is not likely.
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. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).
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