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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-142-3 | CAS number: 103-76-4
- 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
oral: LD50 ca. 4244 mg/kg bw (rat)
inhalation: no mortality/clinical signs observed (rat)
intraperitoneal: LD50 < 678 mg/kg bw (mice)
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (weight variations in animals exceed 20% of the mean weight, observation period of 7 days, no details on animal husbandry)
- 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:
- TEST ANIMALS
- Age at study initiation: young adult laboratory rats
- Weight at study initiation: 100 - 224 g - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- (doubly distilled)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10-20 mL/kg bw
The doses were administered as aqueous solutions of 8% (800 cm³/kg), 20% (1600 cm³/kg) and 30% (3200, 4000 and 5000 cm³/kg) test substance. - Doses:
- 800, 1600, 3200, 4000 and 5000 cm³/kg (849, 1698, 3396, 4244, 5305 mg/kg bw - conversation in mg/kg is based on the density: d= 1.06 g/cm³)
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Frequency of weighing: prior the start of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 4 244 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Corresponds to 4000 cm³/kg; the mg/kg was calculated on the density d: d= 1.061 g/cm³. 1 male/3 females died within the first 24 h post exposure in this dose group.
- Mortality:
- 5305 mg/kg: All females died within the first 24 h and 3 males died within 48 h.
4244 mg/kg: 1 male and 3 females died within the first 24 h.
3396 mg/kg: 1 male and 2 females died within the first 24 h.
1698 mg/kg:1 animal died within 7 days. - Clinical signs:
- other: 5305 and 4244 mg/kg: high stepping gait, motor excitation, intermittent respiration, abdominal position and paresis (hindlimb), immediately after application; piloerection, nose and eyes with reddish crusts, intermittent respiration, apathy and squatting
- Gross pathology:
- Animals that died:
5305 mg/kg: smeared fur (snout and anogenital region), dilatation of the stomach and intestine (partly filled with blood and liquid content).
4244 mg/kg: smeared fur (snout); dilatation of the stomach and intestine (partly filled with blood and liquid content).
3396 mg/kg: smeared fur (snout and anogenital region), diarrhea.
Animals examined at termination of the study: Organs without particular findings. - Interpretation of results:
- GHS criteria not met
Reference
Mortality:
Dose (mg/kg) | Conc.(%) | dead within 1h | dead within 1 day | dead within 2 days | dead within 7 days |
5305 | 30 | 0/10 | 6/10 | 8/10 | 8/10 |
4244 | 30 | 1/10 | 4/10 | 4/10 | 4/10 |
3396 | 30 | 0/10 | 3/10 | 3/10 | 3/10 |
1698 | 20 | 0/10 | 0/10 | 0/10 | 1/10 |
849 | 8 | 0/10 | 0/10 | 0/10 | 0/10 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 244 mg/kg bw
- Quality of whole database:
- equivalent to OECD TG 401
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- (adopted on 1981, 12th may; inhalation hazard test)
- Deviations:
- yes
- Remarks:
- (animals were observed for only 8 days, only 3 animals for each exposure time were used, no details only animal husbandry, exposure period of 8 hours, concentration of test substance in air mixture was not determined)
- GLP compliance:
- no
- Test type:
- other: inhalation hazard test (IHT)
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 172 g (mean) - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- not specified
- Vehicle:
- air
- Details on inhalation exposure:
- The test demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of the test substance at the temperature chosen for vapor generation (20 °C). 6 rats per sex were exposed to the vapors, generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8h. The documentation of clinical signs was performed over a period of 8 days. In order to verify the results, the test was repeated once with new groups of animals.
- Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 8 h
- Concentrations:
- In the study report and the raw data no substance loss but an increase in substance weight was recorded.
- No. of animals per sex per dose:
- 6
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 8 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- discriminating conc.
- Based on:
- test mat.
- Exp. duration:
- 8 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality occured.
- Clinical signs:
- other: No clinical signs observed.
- Body weight:
- The treated animals gained weight (mean weight at study end: 199 g).
- Gross pathology:
- In one animal, chronic bronchitis and bronchiectasis in the right superior lobe of the lung were observed. Other animals were negative.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- equivalent to OECD TG 403
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
oral
Acute oral toxicity was determined in a study equivalent to OECD TG 401. The test item was administered to young laboratory rats (strain not specified) by gavage in doses of 849, 1698, 3396, 4244 and 5305 mg/kg bw (5 animals per dose/sex). The application volume was 10 to 20 mL/kg bw. Doubly distilled water was used as vehicle. Prior start of the study, rats was weighted and the doses were administered in aqueous solutions. Necropsy of survivors was performed and clinical signs were recorded after an observation period of 7 days.
At the highest dose level, all female animals died within 24 h and 3 male animals died within 48 h. At 4244 mg/kg bw one male and 3 female animals died within the first 24 hours. At these dose levels, high stepping gaint, motor excitation, intermitted respiration, piloeration, apathy and squatting posture until including days 3 were recorded. In addition, nose and eyes showed reddish crusts. No clinical signs and findings were observed in the surviving animals from the fifth day onward.
At 3396 mg/kg bw one male and two female animals died within the first 24 hours and at 1698 mg/kg bw one animal died within 7 days. At these doses, clinical signs of irregular respiration and squatting posture from hour 2 until hour 4 after application occurred. No clinical findings were observed in surviving animals from the fifth observation day onward.
Animals examined at termination of the study showed no particular organs findings. Animals which died during the study had smeared fur, dilatation of the stomach and the intestine was partly filled with blood and liquid (5306 mg/kg bw and 4244 mg/kg bw).
The LD50 was ca. 4244 mg/kg bw for male and female animals (BASF, 1968).
inhalation
An inhalation hazard test equivalent to OECD TG 403 (1981) was performed to assess the acute inhalation toxicity. Male and female rats (strain not specified) were exposed to vapors of the test substance in air mixture (concentration not determined) for a period of 8 hours. The test demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of the test substance at the temperature chosen for vapor generation (20 °C). 6 rats per sex were exposed to the vapors. The documentation of clinical signs was performed over a period of 8 days. In order to verify the results, the test was repeated once with new groups of animals. Necropsy of all animals was performed. No mortality occurred and no clinical signs were observed. The treated animals gained weight. Only one animal showed chronic bronchitis and bronchiectasis in the right lobe of the lung. No LD50 was determined (BASF AG, 1967).
intraperitoneal
In a standardized BASF study, the acute toxicity of the test item after single intraperitoneal administration was assessed. Doses of 212, 424, 678, 848 mg/kg bw of the test substance were administered to mice, while 5 animals per dose were utilized. The duration of observation was 7 days. Immediately after application, labored respiration, aqueous secretion from the oral cavity, shrunken flanks, high stepping gait, indicated morphine tails, abdominal position and closed eyes were observed. During the following days, the surviving animals showed clotted eyes, scrubby fur, accelerated respiration. 5 to 6 days after exposure, no clinical signs were observed. At the highest dose level all animals died within 48 h. At 678 mg/kg bw all female and 2 male animals died within 48 hours post application. At 424 mg/kg bw one male and one female died within the 7 day observation period. Animals that died during the study showed livers with bloody pigmentation and intestine filled with bloody fluids. Animals examined at termination of the study showed connation of liver and stomach. The LD50 for male and female mice after i.p. application was < 678 mg/kg bw (BASF, 1968).
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The oral LD50 was ca. 4244 mg/kg bw. As a result the substance is not classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179. An inhalation study with an atmosphere saturated with vapors of the test item revealed no adverse effects and therefore no classification for acute inhalation toxicity is warranted.
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.