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Diss Factsheets
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EC number: 249-320-4 | CAS number: 28940-11-6
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as corrosive to the skin
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with REACH Regulation (EC) 1907/2006 as amended: Annex VII, section 8.1.1: an acute dermal toxicity study should be avoided, in particular in relation with animal welfare considerations, because the substance was shown to be corrosive to the skin in a new in vitro skin corrosion EpiDerm test (Envigo, 2017, Rel.1). Due to its corrosive properties, the substance is presumed to cause toxicity by dermal exposure. When administered by the oral route, the substance induced narcotic effects (Safepharm, 2008, OECD 420, GLP, Rel 1.). Those effects can be anticipated with an exposure via the dermal route, therefore, the substance is also classified as STOT SE3 (H336) by the dermal route.
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 20 to March 11, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- adopted 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Compliance Programme (inspected on August 30, 2005/ signed on November 21, 2005)
- 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 (UK) Ltd, Margate, Kent, UK.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 204-219 g
- Fasting period before study: Animals were fasted for overnight period before administration of test material and for approximately 3-4 h after dosing.
- Housing: Animals were housed in groups of up to 4 in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: Food (Certified Rat and Mouse Diet), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: 15 changes/h
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: From: February 20, 2008 To: March 11, 2008 - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Justification for choice of vehicle: Arachis oil BP was used as vehicle because the test material did not dissolve/suspend in distilled water.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION: Test material was freshly prepared, as required, as a solution in arachis oil BP.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Using available information on the toxicity of the test material, 2000 mg/kg bw was chosen as the starting dose. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- - Sighting study: 1 female/dose
- Main study: 5 females/dose (1 animal included from sighting study) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations were made 0.5, 1, 2 and 4 h after dosing and then daily for up to 14 days. Morbidity and mortality checks were made twice daily. Body weight of each animal was recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: Yes; on completion of the observation period, animals were killed by cervical dislocation and subjected to gross necropsy. - Statistics:
- None
- Preliminary study:
- - No mortality was observed at 2000 mg/kg bw.
- Ataxia and hunched posture were observed. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - No mortality was observed at 2000 mg/kg bw.
- Clinical signs:
- other: - Signs of systemic toxicity observed up to one day after dosing were hunched posture, ataxia, decreased respiratory rate, lethargy, laboured respiration, ptosis, loss of righting reflex and splayed gait. - Animals appeared normal one or two days after d
- Gross pathology:
- - No abnormalities were noted at necropsy.
- Other findings:
- None
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the test conditions, the substance is::
- not classified according to the Annex VI of the Regulation EC No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw.
- classified as 'category 5' according to the GHS based on narcotic effects observed at 2000 mg/kg bw.
Based on narcotic effects observed at the dose level of 2000 mg/kg bw, the test material is classified as a specific target organ toxicant after single exposure, H336: May cause drowsiness or dizziness according to the Regulation (EC) No. 1272/2008 (CLP)
and to the GHS. - Executive summary:
In an acute oral toxicity study (limit test) performed according to OECD Guideline No. 420 and in compliance with GLP, female Sprague-Dawley CD (Crl: CD® (SD) IGS BR) strain rats were administered a single oral dose of test material by gavage.
Following a sighting study using one animal at a dose level of 2000 mg/kg bw, additional 4 animals were administered a single oral dose of test item at 2000 mg/kg bw (main study). Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.
No mortality was observed. Signs of systemic toxicity observed up to one day after dosing were hunched posture, ataxia, decreased respiratory rate, lethargy, laboured respiration, ptosis, loss of righting reflex and splayed gait. Animals appeared normal one or two days after dosing. All animals showed expected gains in body weight over the 14 day study period. No abnormalities were noted at necropsy.
Rat Oral LD50 (females) > 2000 mg/kg bw
Under the test conditions, the oral LD50 for the registered substance is higher than 2000 mg/kg bw in rats therefore:
- it is not classified according to the Annex VI of the Regulation EC No. 1272/2008 (CLP).
- it is classified as 'category 5' according to the GHS base on narcotic effects.
Based on narcotic effects observed at the dose level of 2000 mg/kg bw, the test material is classified as a specific target organ toxicant after single exposure, H336: May cause drowsiness or dizziness according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
None
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.