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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-678-8 | CAS number: 109-53-5
- 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
The oral LD50 in rats was >7700 mg/kg bw.
The dermal LD50 in rabbits was 15400 mg/kg bw.
In acute inhalation studies in rats the LC50 (4 h) was > 21000 mg/m³.
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:
- other: Comparable to guideline study with acceptable restrictions. Restrictions: purity of test substance not reported; observation period only 7 days; no data about body weight.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (post exposure observation period 7 days)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Gassner
Mean body weights: 199 g (males), 169 g (females)
no further details - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- aqueous carboxymethyl cellulose (CMC) emulsion, content of IBVE 30%.
- Doses:
- Dose levels: 6400, 8000, and 10000 µL/kg bw (i.e. 4920, 6150, 7690 mg/kg bw).
- No. of animals per sex per dose:
- 5
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Weighing: initial weight
- Necropsy of survivors performed: yes - Statistics:
- no data
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 7 700 mg/kg bw
- Remarks on result:
- other: (10 mL/kg bw); no mortality at this dose level
- Mortality:
- There was no mortality except 1/5 mid dose female that died within 48 h postdose.
- Clinical signs:
- other: Low dose animals: stagger within few minutes. Hunched posture, apathy, and dyspnoea within hours. Eyes reddish encrusted for several days. No findings on day 5 postdose and thereafter. Mid and high dose animals: abdominal position, apathy, dyspnoea. Hun
- Gross pathology:
- General congestion.
- Other findings:
- no data
- Conclusions:
- In an acute oral toxicity study in rats the LD50 was >10 mL/kg bw (corresponding to >7700 mg/kg bw) at a post exposure observation period of 7 days.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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:
- other: Comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- 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:
- Mean body weights: 267 and 183 g for male and female rats, respectively
Age: 8 to 9 weeks at start of treatment
Rats received standard diets and water ad libitum
Room temperature was 20-24°C
Relative air humidity 30-70%. - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: air
- Details on inhalation exposure:
- The animals were singly placed into compartments in an inhalation chamber (glass-steel, volume 200 l). Atmosphere was dynamically generated. Air passed an evaporator to which TS was pumped. Vapors were mixed with fresh air. Air was delivered to the inhalation chamber at a rate of 3000 l/h.
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- (the concentration was measured using gas chromatography)
- Duration of exposure:
- 4 h
- Concentrations:
- 21.1 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Post exposure period was 14 days.
The animals were observed for clinical signs of toxicity on working days and daily for mortality for 14 days. Body weights were recorded on days 0, 7, and 14. At the end of the observation period the animals were sacrificed and necropsied. - Statistics:
- Binominal test (Wittig 1974) was used.
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- 21.1 mg/L air (analytical)
- Exp. duration:
- 4 h
- Remarks on result:
- other: clinical signs but no mortality, 14 d observation period
- Mortality:
- no mortality
- Clinical signs:
- other: During exposure: apathia, stagger, depressed breathing, reddened ears and extremities, unkempt fur. After exposure: unsteady gait. No symptoms were noted from the day following exposure.
- Body weight:
- Body weight development was comparable to historical controls but slightly delayed in females.
- Gross pathology:
- No effects detected at necropsy.
- Other findings:
- no
- Conclusions:
- In an acute inhalation study in rats no mortality was found after 4 h exposure to 21.1 mg/L and a post exposure period of 14 days (the recommended limit dose according to OECD TG403 is 5 mg/L); LC50 (4h) > 21 mg/L.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Restriction: purity of test substance not stated; no data on clinical signs; no necropsy; only males.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Male albino New Zealand rabbits weighing 2.5 to 3.5 kg were used.
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Groups of 4 animals were used. Dosages up to 20 mL/kg bw were placed on the shaved rabbit skin under occlusive dressing. The animals were immobilized during the 24 hour contact period.
- Duration of exposure:
- 24 h
- Doses:
- up to 20 mL/kg bw (corresponding to 15400 mg/kg bw)
- No. of animals per sex per dose:
- 4
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no
- no data about clinical signs & body weight - Statistics:
- LD50-values were estimated by the method of Thompson using the tables of Weil, based on mortalities noted during the 14-day observation period.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 15 400 mg/kg bw
- Remarks on result:
- other: corresponding to 20 mL/kg bw
- Conclusions:
- In male New Zealand White rabbits the dermal LD50 was 20 mL/kg bw corresponding to 15400 mg/kg bw. The recommended limit dose according to OECD TG402 is 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 15 400 mg/kg bw
Additional information
Oral application
In an acute oral toxicity study in rats (BASF 1974; 5 male and 5 female rats gavaged with 6400, 8000, or 10000 µL/kg bw corresponding to 4920, 6150, 7690 mg/kg bw) no mortality was found, the LD50 was > 7700 mg/kg bw at a post exposure observation period of 7 days. Clinical signs were detected at >= 4920 mg/lg bw like staggered gait within few minutes and hunched posture, apathy, and dyspnoea within hours. Eyes reddish encrusted for several days. No findings were seen on day 5 postdose and thereafter at the low dose level and at mid and high dose level at day 7 postdose.
In a further study in male rats the LD50 was 13100 mg/kg bw (Smyth et al., 1962, limited documentation).
Inhalation
In an acute inhalation study in rats (BASF1988) no mortality was found after 4 h exposure to 21.1 mg/L and a post exposure period of 14 days (n=5 per sex; the recommended limit dose according to OECD TG403 is 5 mg/L); the LC50 (4h) is > 21 mg/L. During exposure apathia, stagger, depressed breathing, reddened ears and extremities, unkempt fur were recorded and after exposure an unsteady gait. No symptoms were noted from the day following exposure.
No mortality was seen in 6 males and 6 female rats after exposure to the saturated vapour (20°C) for 3 minutes but lethal effects in 2/3 males and 2/3 females at an exposure duration of 10 minutes (estimated concentration 480 mg/L; BASF 1974).
Dermal application
In a study with limited documentation (Smyth et al., 1962) it was reported that in male New Zealand White rabbits (n=4 per dose) the dermal LD50 was 20 mL/kg bw corresponding to 15400 mg/kg bw.
Justification for classification or non-classification
Classification for acute toxicity is not warranted according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (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.