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EC number: 701-300-0 | CAS number: -
- 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 toxicity study in 6 female rats, conducted in accordance with OECD 423 (2001), EU Method B.1 tris (2008), EPA OPPTS 870.1100 (2002) and according to GLP principles, a LD50 oral of >2000 mg/kg bw was determined. In an acute inhalation study in 5 male and 5 female rats, conducted in accordance with OECD 403 (2009) and according to GLP principles, a 4h-LC50 of >5.04 mg/L was determined. In an acute dermal toxicity study in 5 male and 5 female rats, performed in accordance with OECD 402 (1987), EU Method B.3 ( 2008), EPA OPPTS 870.1200 (1998) and according to GLP principles, a LD50 of >2000 mg/kg bw was determined. No mortality occurred in these studies.
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:
- December 7, 2010 - February 21, 2011
- 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:
- (2001)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- (2002)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation:
Step 1/animals no. 1-3: 172-181 g
Step 2/animals no. 4-6: 155-162 g
- Fasting period before study: 16 to 19 hours
- Housing: the animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 040810)
- Diet: free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1013). Free access again from 4 hrs post dosing.
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 per hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Date of Dose Administration:
Step 1, animals no. 1, 2 and 3: December 22, 2010
Step 2, animals no. 4, 5 and 6: December 29, 2010 - Route of administration:
- oral: gavage
- Vehicle:
- cotton seed oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.4 g/mL
- Amount of vehicle: 5 mL
- Justification for choice of vehicle: due to its non-toxic characteristics
- Lot/batch no.: Sigma, lot no. MKBB7604, expiry date 30/01/2011
- Purity: not applicable
DOSE VOLUME APPLIED: 5 mL/kg
DOSAGE PREPARATION: the test item was weighed out into a tared plastic vial on a precision balance. Homogeneity was maintained by vortexing. The dosages were made shortly before administration.
CLASS METHOD
- Rationale for the selection of the starting dose: no details provided - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 females twice (6 females in total)
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: the animals were weighed on day 1 (prior to the administration), on day 8 (1 week thereafter) and on day 15 (2 weeks thereafter)
- Frequency of observations: a careful clinical examination was made several times on the day of dosing (at least once during the 1st 30 minutes and with special attention given during the 1st 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. According to the OECD Guideline.
- Necropsy of survivors performed: yes - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality occurred
- Mortality:
- - No mortality occurred
- Clinical signs:
- other: - At 3 and 4 hours after administration, slight to moderate piloerection was observed in animal #1 and #2 until day 2 - No other signs in any of the animals at any observation time
- Gross pathology:
- - No abnormalities were observed
- Interpretation of results:
- other: the substance does not need to be classified for acute toxicity by the oral route according to GHS and CLP
- Conclusions:
- In an acute oral toxicity study in female rats, conducted in accordance with OECD 423 (2001), EU Method B.1 tris (2008), EPA OPPTS 870.1100 (2002) and according to GLP principles, an LD50 oral of >2000 mg/kg was determined.
- Executive summary:
The acute oral toxicity in female rats has been studied in accordance with OECD 423 (2001), EU Method B.1 tris (2008), EPA OPPTS 870.1100 (2002) and according to GLP principles. The substance was dosed in cotton seed oil at 2 g/kg bw in 6 female rats, in 2 steps. The only sign of reaction to treatment, slight to moderate piloerection, was observed 3 and 4 hours after administration in two animals, until day 2. No mortality occurred. Necropsy did not show any abnormality. The acute oral toxicity (LD50) was determined to be >2000 mg/kg. Based on this result, the substance does not need to be classified for acute toxicity by the oral route.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study has Klimisch score 1
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 2, 2010 - June 7, 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- (2009)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories, Indianapolis, IN, USA (received on April 19, 2011)
- Age at study initiation: 8 weeks
- Weight at study initiation: 254-282 g (males) and 170-213 g (females)
- Fasting period before study: no data
- Housing: singly housed in suspended stainless steel caging with mesh floors
- Diet: Purina Rodent Chow #5012
- Water: tap water (ad libitum, except during exposure)
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23 °C and 20-21 °C (during exposure)
- Humidity (%): 42-66% and 50-53% (during exposure)
- Air changes (per hr): 12 per hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light - 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: a nose-only inhalation chamber (ADG Developments Ltd.)
- Method of holding animals in test chamber: individually in polycarbonate holding tubes
- Source and rate of air: approximately 40 liters per minute of filtered air was supplied by an air compressor (Airgas) to the dust generator
- Method of conditioning air: an additional 30 liters per minute of compressed mixing air, supplied using air from a compressed air tank (Airgas), was introduced into the chamber, creating a vortex at the chamber inlet
- System of generating particulates/aerosols: the unground substance was aerosolized using a Dust Generator with an accurate dry material feeder apparatus
- Method of particle size determination: an eight-stage ACFM Andersen Ambient Particle Sizing Sampler was used to assess the particle size distribution of the test atmosphere. Samples were withdrawn from the breathingzone of the animals at 2 intervals.
- Treatment of exhaust air: not applicable
- Temperature, humidity, pressure in air chamber: the exposure tube temperature and relative humidity ranges during exposure were 20-22 degrees Celsius and 30-44%, respectively
TEST ATMOSPHERE
- Samples taken from breathing zone: yes
- MMAD (Mass median aerodynamic diameter): 3.8 µm
CLASS METHOD
- Rationale for the selection of the starting concentration: not reported - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.04 mg/L (time weighted average)
- No. of animals per sex per dose:
- 5
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body weights: prior to exposure and on days 1, 3, 7 and 14
Clinical signs: upon removal from the exposure tube, after 3 hrs and daily thereafter
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.04 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: Time weighted average chamber concentration; no mortality
- Mortality:
- - There were no mortalities during the study
- Clinical signs:
- other: - Within 3 hours post-exposure, 3 animals exhibited ocular discharge, irregular respiration or hypoactivity. These animals recovered quickly. - No other signs of treatment were observed during the study
- Body weight:
- - No abnormalities were observed
- Gross pathology:
- - In 2 males there was coagulated blood in their abdominal cavity
- No other abnormalities were observed - Interpretation of results:
- other: the substance does not need to be classified for acute toxicity by the inhalation route according to GHS and CLP
- Conclusions:
- In an acute inhalation study in rats, conducted in accordance with OECD 403 (2009) and according to GLP principles, rats (5 males and 5 females) were exposed by the nose only. The MMAD of the substance was determined to be 3.8 µm. All animals survived. Only within 3 hours post-exposure, 3 animals exhibited ocular discharge, irregular respiration or hypoactivity. The animals recovered quickly and appeared healthy over the remainder of the observation period. Necropsy showed the presence of coagulated blood in the abdominal cavity of 2 males. Based on the results of this study, the 4h-LC50 was determined to be >5.04 mg/L and the substance does not need to be classified for acute toxicity by the inhalation route.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 040 mg/m³ air
- Quality of whole database:
- The study has Klimisch score 1
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 19, 2010 - January 3, 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Wistar strain, Crl:WI (Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation:
Males: 7-8 weeks
Females: 14 weeks
- Weight on the day of administration:
Males: 272-290 g
Females: 214-230 g
- Housing: Individually in IVC cages, type III H, polysulphone
- Diet: ad libitum (Altromin 1324)
- Water: ad libitum (tap water, sulphur acidified to a pH value of approx. 2.8)
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- water
- Remarks:
- (aqua ad injectionem (Berlin Chemie, lot no. 0195A191, expiry date: 04/2013))
- Details on dermal exposure:
- TEST SITE
- Approximately 24 hours before the test, the fur was removed from the dorsal area of the trunk by using an electric clipper.
- Area of exposure: approx. 10% of the total body surface
- Dressing: gauze and non-irritating tape, which was fixed with an additional dressing
REMOVAL OF TEST SUBSTANCE
- Washing: yes, using water
- Time after start of exposure: 24 hours
VEHICLE AND WATER USED FOR REMOVAL OF TEST SUBSTANCE
Aqua ad injectionem (Berlin Chemie, lot no. 0195A191, expiry date: 04/2013) - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: The animals were weighed on day 1 (prior to the application) and on days 8 and 15
- Frequency of observations: A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period.
- Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Necropsy of survivors performed: yes
- Other: Signs of erythema and oedema were assessed using the scoring system laid down in OECD 404 (2002) - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality and no clinical signs of toxicity occurred
- Mortality:
- No mortality occurred
- Clinical signs:
- other: No clinical signs of toxicity occurred
- Gross pathology:
- Macroscopic examination of the animals did not reveal any abnormalities.
- Other findings:
- - Eschar was observed in 2 males, on day 9 only
- Eschar was observed in all females, in the period day 4-9 - Interpretation of results:
- other: the substance does not need to be classified for acute toxicity by the dermal route according to GHS and CLP
- Conclusions:
- In an acute dermal toxicity study with rats, performed in accordance with OECD 402 (1987), EU Method B.3 ( 2008), EPA OPPTS 870.1200 (1998) and according to GLP principles, a LD50 of >2000 mg/kg bw was determined.
- Executive summary:
The acute dermal toxicity of the substance was determined in the rat, in accordance with OECD 402 (1987), EU Method B.3 ( 2008), EPA OPPTS 870.1200 (1998) and according to GLP principles. The substance was administered to five Wistar rats of each sex by a single dermal application of 2000 mg/kg bw for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality and no clinical signs of toxicity occurred. A slight weight loss was recorded in 3 females during the first week. Eschar was observed in 2 males, on day 9 only, and in all females, in the period day 4 -9. Macroscopic examination of the animals did not reveal any abnormalities. The dermal LD50 value of the substance in Wistar rats was established to be >2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study has Klimisch score 1
Additional information
Acute toxicity: oral
The acute oral toxicity in female rats has been studied in accordance with OECD 423 (2001), EU Method B.1 tris (2008), EPA OPPTS 870.1100 (2002) and according to GLP principles. The substance was dosed in cotton seed oil at 2 g/kg bw in 6 female rats, in 2 steps. No mortality occurred. The only sign of reaction to treatment, slight to moderate piloerection, was observed 3 and 4 hours after administration in two animals, until day 2. Macroscopic examination of the animals did not reveal any abnormalities. The acute oral toxicity (LD50) was determined to be >2000 mg/kg bw.
Acute toxicity: inhalation
In an acute inhalation study in rats, conducted in accordance with OECD 403 (2009) and according to GLP principles, rats (5 males and 5 females) were exposed for 4 hours by the nose only. The MMAD of the substance was determined to be 3.8 µm. All animals survived. Only within 3 hours post-exposure, 3 animals exhibited ocular discharge, irregular respiration or hypoactivity. The animals recovered quickly and appeared healthy over the remainder of the observation period. Necropsy showed the presence of coagulated blood in the abdominal cavity of 2 males. Based on the results of this study, the 4h-LC50 was determined to be >5.04 mg/L.
Acute toxicity: dermal
The acute dermal toxicity of the substance was determined in the rat, in accordance with OECD 402 (1987), EU Method B.3 ( 2008), EPA OPPTS 870.1200 (1998) and according to GLP principles. The substance was administered to five Wistar rats of each sex by a single dermal application of 2000 mg/kg bw for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality and no clinical signs of toxicity occurred. A slight weight loss was recorded in 3 females during the first week. Eschar was observed in 2 males, on day 9 only, and in all females, in the period day 4 -9. Macroscopic examination of the animals did not reveal any abnormalities. The dermal LD50 value of the substance in Wistar rats was established to be >2000 mg/kg bw.
Justification for classification or non-classification
The substance does not need to be classified for acute toxicity in accordance with the CLP Regulation as the acute oral and dermal toxicity is >2000 mg/kg bw and as the acute inhalation toxicity is >5.04 mg/L.
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