Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 261-767-7 | CAS number: 59447-55-1
- 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
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:
- 03/04/2003-29/05/2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP comparable to OECD guideline
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- /
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: within an interval of +/-20% of the mean initial bodyweight of the first treated group except for animal number 5-2 whose bodyweight was approximately +22% of the mean initial bodyweight of the first treated group. This deviation was considered not to affect the purpose or integrity of the study.
- Fasting period before study: an overnight fast immediately before dosing and for approximately 3-4 hours after dosing
- Housing: in groups in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):19-25°C
- Humidity (%):30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12 hrs dark/12hrs light - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:5, 30, 200, 200, 500 mg/ml
- Amount of vehicle (if gavage): calcultated according to the fasted bodyweight at the time of dosing.
MAXIMUM DOSE VOLUME APPLIED: 10
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: using all available information on the toxicity of the test material, 50mg/kg was chosen at the starting dose. - Doses:
- 50, 300, 2000, 2000, 5000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 2, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy, mortality - Statistics:
- /
- Preliminary study:
- /
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no deaths
- Clinical signs:
- other: no signs of systemic toxicity
- Gross pathology:
- No abnormalities were noted at necropsy
- Other findings:
- /
- Conclusions:
- The acute oral medial lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated as being greater than 5000mg/kg bodyweight.
- Executive summary:
Introduction.
The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the following:
- OECD Guidelines for the Testing of Chemicals No. 423 “Acute Oral Toxicity – Acute Toxic Class Method” (adopted 17 December 2001)
- United States Enviro
nmental Protection Agency Health Effects Test Guidelines OPPTS 870.1100 Acute Oral Toxicity, 2002
Method.
A group of three fasted females was treated with the test material at a dose level of 50 mg/kg bodyweight. Based on the results from this dose level further groups of fasted females were treated at dose levels of 300, 2000 and 5000 mg/kg bodyweight. Dosing was performed sequentially. The test material was administered orally as a suspension in arachis oil BP. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Mortality. There were no deaths.
Clinical Observations. There were no signs of systemic toxicity.
Bodyweight. All animals showed expected gains in bodyweight over the study period.
Necropsy. No abnormalities were noted at necropsy.
Conclusion. The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated as being greater than 5000 mg/kg bodyweight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- 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
- Study period:
- 02/03/2012-04/04/2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP comparable to OECD guideline
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- only one dose level was conducted
- Principles of method if other than guideline:
- /
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: RccHan: WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation:8-12 weeks
- Weight at study initiation: 200-350g
- Housing: in groups of three by sex in solid-floor polypropylene cages with stainless steel lids, furnished with softwood flakes and provided with environmental enrichment items: wooden chew blocks and cardboard 'fun tunnels".
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Air changes (per hr):15
- Photoperiod (hrs dark / hrs light): 12hrs light/12hrs dark - 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: chambers from ADG Developments Ltd., Hitchin, Herts, UK
- Exposure chamber volume: 30 litres
- Method of holding animals in test chamber: in a tapered, polycarbonate restraining tube
- Method of conditioning air: compressed air was passed through a water tap and respiratory quality filter
- System of generating particulates/aerosols:SAG 410 Solid Aerosol Generator (TOPAS GmbH, Dresden, Germany)
- Method of particle size determination: Marple Personal Cascade Impactor (Westech IS Ltd., Beds, UK)
- Temperature, humidity, pressure in air chamber: temperature and relative humidity were measured by an electronic thermometer/humidity meter (Hanna Instruments Ltd., Beds, UK)
TEST ATMOSPHERE
- Brief description of analytical method used: the gravimetric method used glass fibre filters placed in a filter holder. The holder was temporarily sealed in a vacant port in the exposure chamber in the animals' breathing zone and a suitable, known volume of exposure chamber air was drawn through the filter using a vacuum pump. Each filter was weighed before and after samling in order to calculate the weight of collected test item. The difference in the two weights, divided by the volume of atmosphere sampled, gave the actual chamber concentration.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: determined three times during the exposure period
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD = 2.80 μm, GSD = 2.22
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: 1.0mg/l as the mean achieved concentration was 102% of target and no deaths occured, no further levels were required. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- by weight difference
- Duration of exposure:
- 4 h
- Concentrations:
- 1.0 mg/l
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:at hourly intervals during exposure, immediatly on removal from the restraining tubes at the end of exposure, one hour after termination of exposure and subsequently once daily for fourteen days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- /
- Preliminary study:
- /
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1.02 mg/L air (analytical)
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: Signs of hunched posture, pilo-erection and red/brown staining around the snout are commonly seen in animals for short periods on removal from the chamber following 4-hour inhalation studies. Wet fur is commonly recorded during exposure. These observation
- Body weight:
- All male animals and two females exhibited slight bodyweight losses on the first day post-exposure. Reasonable bodyweight development was noted for all animals during the remainder of the recovery period.
- Gross pathology:
- No macroscopic abnormalities were detected
- Other findings:
- /
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- No deaths occured in a group of six rats exposed to a mean achieved atmosphere concentration of 1.02mg/L for four hours. It was therefore considered that the acute inhalation median lethal concentration (4hr LC50) of FR-1025M, in the RCCHan:WIST strain rat was greater than 1.02mg/L (GHS - Category 4, > 1-5mg/L.
- Executive summary:
INTRODUCTION
A study was performed to assess the acute inhalation toxicity of the test item. The method was compatible with that described in the OECD No. 436, with the exception that only one dose level was conducted.
METHODS
A group of six RccHan:WIST strain rats (three males, three females) was exposed to a dust atmosphere. The animals were exposed for four hours using a nose only exposure system, followed by a fourteen day observation period.
RESULTS
The mean achieved atmosphere concentration was 1.02 mg/L (Std. Dev.: 0.05mg/L, nominal: 9.64 mg/L)
An example calculation for determining test atmosphere concentration is shown below:
Sample number Time (mins) Filter weights (mg) Difference (mg) Sample volume (L) Concentration (mg/l) Pre-sample Post-sample 1 5 32.57 36.61 4.04 4 1.01 The characteristics of the achieved atmosphere were as follows:
Mean achieved atmosphere concentration (mg/L) Mean mass median aerodynamic diameter (µm) Inhalable fraction (% < 4µm) Geometric standard deviation 1.02 2.80 67.4 2.22
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 1 020 mg/m³ air
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:
- 09/04/2003-23/4/2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP comparable to OECD guideline
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- /
- GLP compliance:
- yes (incl. QA statement)
- 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., Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 200g
- Housing: in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hrs light, 12hrs dark - Type of coverage:
- semiocclusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flank
- % coverage: 10%
- Type of wrap if used: surgical gaze and semi-occluded with a piece of self-adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with cotton wool moistened with distilled water to remove any residual test material.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000mg/kg
- Constant volume or concentration used: yes - Duration of exposure:
- 24h
- Doses:
- 5000mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- /
- Preliminary study:
- /
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no deaths
- Clinical signs:
- other: no signs of systemic toxicity
- Gross pathology:
- no abnormalities
- Other findings:
- Dermal reaction: no signs of dermal irritation
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 5000mg/kg bw
- Executive summary:
INTRODUCTION
The study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the following:
* OECD 402
* EU method B3
* OPPTS 870.1200
METHOD
A group of ten animals was given a single, 24 -hour, semi-occluded dermal application of undiluted test material to intact skin at a dose level of 5000mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
MORTALITY: There were no deaths
CLINICAL OBSERVATIONS: no signs of systemic toxicity
DERMAL IRRITATION: no signs of dermal irritation
BODYWEIGHT: all animals showed expected gains in bodyweight over the study period, except for one female treated at a dose level of 5000mg/kg that showed a bodyweight loss during the first week and expected gain in bodyweight over the second week.
NECROPSY: no abnormalities were noted at necropsy
CONCLUSION: The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 5000mg/kg bodyweight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
The most recent study
Justification for selection of acute toxicity – inhalation endpoint
One study available
Justification for selection of acute toxicity – dermal endpoint
One study available
Justification for classification or non-classification
Based on the results of the studies, the substance does not need to be classified according to CLP-Regulation (EC) No 1272/2008
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.