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EC number: 228-327-6 | CAS number: 6227-20-9
- 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 a fixed dose procedure female rats received a single dose of 2000 (1 female) and 300 mg/kg bw (5 females) by gavage. Rats were observed for 14 days thereafter. The female at 2000 mg/kg bw died within one day after dosing showing reduced body weight, purple staining of the urine and abnormally red lungs, dark liver, dark kidneys, dark purple coloured substance present in the stomach and purple colored staining of the small intestine. Females at 300 mg/kg did not show any effects on body weight, clinical signs and macroscopic investigations. The faeces of 4 of these females was purple stained. Based on these findings the oral LD50 of the substance is between 300 and 2000 mg/kg bw.
In a test according to OECD 402 Wistar rats (5/sex) received 2000 mg/kg bw of the test substance on the skin during 24 hours. During the 14 day observation period no mortality and clinical signs were observed. Body weight was in normal ranges except for one female. Another female developed scabs. No abnormalities were found at necropsy. The LD50 of the substance is > 2000 mg/kg bw.
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:
- 10 January 2017 to 1 february 2017
- 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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Strain: RccHan™:WIST
- Females (if applicable) nulliparous and non-pregnant:yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 152-201 g
- Fasting period before study: overnight before dosing and 3-4 hours after dosing
- Housing: solid-floor polypropylene cages furnished with woodflakes (maximum 4/cage)
- Diet: 2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15/hour
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: solubility
MAXIMUM DOSE VOLUME APPLIED: 10 mL
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: statring dose 300 mg/kg bw in absence of any information on toxicity - Doses:
- 300 mg/kg bw 1 female
2000 mg/kg bw 1 female
300 mg/kg bw 4 additional females - No. of animals per sex per dose:
- at 2000 mg/kg bw 1 female; at 300 mg/kg bw 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
mortality: twice daily (once in weekends)
clinical signs: 30 minutes, 1, 2, and 4 hours after dosing and then daily for up to 14 days
bodyweight: day 0, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- NA
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1 female at 2000 mg/kg bw on day 1
- Clinical signs:
- none observed at 300 and 2000 mg/kg bw
at 2000 mg/kg bw: purple staining of urine
at 300 mg/kg bw: black/purple staining of faeces 4/5 females - Body weight:
- at 2000 mg/kg bw: decreased by ca 10% within one day
at 300 mg/kg bw within normal ranges - Gross pathology:
- at 2000 mg/kg bw: abnormally red lungs, dark liver, dark kidneys, dark purple coloured substance present in the stomach and purple colored staining of the small intestine
at 300 mg/kg bwno abnormalities observed - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The oral LD50 of the substance is between 300 and 2000 mg/kg bw
- Executive summary:
In a fixed dose procedure female rats received a single dose of 2000 (1 female) and 300 mg/kg bw (5 females) by gavage. Rats were observed for 14 days thereafter. The female at 2000 mg/kg bw died within one day after dosing showing reduced body weight, purple staining of the urine and abnormally red lungs, dark liver, dark kidneys, dark purple coloured substance present in the stomach and purple colored staining of the small intestine. Females at 300 mg/kg did not show any effects on body weight, clinical signs and macroscopic investigations. The faeces of 4 of these females was purple stained. Based on these findings the oral LD50 of the substance is between 300 and 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 300 mg/kg bw
- Quality of whole database:
- LD50 between 300 and 2000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
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:
- 29 March 2017 to 28 April 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- As the acute oral LD50 leads to classification, the acute dermal study cannot be waived.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain; RccHan:WIST
- Source: Envigo RMS (UK) Limited, Oxon, UK.
- Females nulliparous and non-pregnant:yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: males 255-275 g; females 201-236 g
- Fasting period before study: none
- Housing: 1 male+ 1 females individually; 4 males + 4 females individually during exposure and 4/sex per cage during the rest of the test period in suspended solid floor polypropylene cages furnished with woodflakes
- Diet: 2014C Teklad Global Rodent diet ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70 %
- Air changes (per hr): at least 15/h
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- % coverage: ca 10% of body surface
- Type of wrap if used: surgical gauze semi-occluded with a piece of self-adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes wiped with distilled water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied:2000 mg/kg bw (moistened with distilled water)
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 1 male + 1 female followed by 4 males + 4 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: at 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days (includes signs of irritation)
- Bodyweight: on day 1 7 and 14
- Necropsy of survivors performed: yes
- Statistics:
- NA
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- none
- Body weight:
- one female did not gain weaight
- Gross pathology:
- no findings
- Other findings:
- No irritation observed. All animals showed staining of the skin at the test site up to day 4 and one female with scabs
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the substance is > 2000 mg/kg bw
- Executive summary:
In a test according to OECD 402 Wistar rats (5/sex) received 2000 mg/kg bw of the test substance on the skin during 24 hours. During the 14 day observation period no mortality and clinical signs were observed. Body weight was in normal ranges except for one female. Another female developed scabs. No abnormalities were found at necropsy. The LD50 of the substance is > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Justification for classification or non-classification
Based on the available information the substance needs to be classified as harmful after oral exposure (H302, harmful if swallowed) according to Regulation (EC) No 1272/2008 (CLP)
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.
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