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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 210-036-0 | CAS number: 603-35-0
- 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
Based on key study results, the oral LD50 of the test material in rats is 700 mg/kg bw (BASF SE, 1952), the inhalation LC50 (4 hours) in rats is 12.5 mg/L (Waritz, 1975) and the dermal LD50 in rabbits is >4000 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:
- May - September 1951
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Screening test; discrepancy between documented test parameters and standard methods, but scientifically acceptable.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- BASF-internal standard method, conducted before OECD 423 was in place
- Principle of test: The acute oral toxicity to rats was evaluated by a single administration of 10% oily suspension, equivalent to doses of 250, 500, 1000 and 2000 mg/kg test material. Afterwards, the animals were observed 8 days for mortality and syptoms of acute intoxication. Dead animals, time to death and symptoms of acute intoxication were recorded. The mean lethal dose was determined. - GLP compliance:
- no
- Limit test:
- no
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final dilution of a suspended solid: 10 %
FORM AS APPLIED IN THE TEST (if different from that of starting material): oily suspension - Species:
- rat
- Strain:
- other: albino
- Sex:
- not specified
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10% - Doses:
- 250, 500, 1000, 2000 mg/kg bw
- No. of animals per sex per dose:
- - sex unspecified, 5-10 animals per dose group
- 250 mg/kg: 5 animals
- 500 mg/kg: 10 animals
- 1000 mg/kg: 10 animals
- 2000 mg/kg: 5 animals - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 8 days
- Frequency of observations: daily - Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 700 mg/kg bw
- Remarks on result:
- other: 1/10 dead at 500 mg/kg; 10/10 dead at 1000 mg/kg
- Mortality:
- No mortality at 250 mg/kg bw, but 1/10 at 500 mg/kg and 100% at doses > 1000 mg/kg. Death occured within 1 - 4 days after application.
- Clinical signs:
- other: Animals that died showed apathy, impaired balance and inappetence. No clinical findings in all surviving animals.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- LD50 = 700 mg/kg
- Executive summary:
The acute oral toxicity to rats was evaluated according to a BASF-internal standard method. Therefore, a single administration of 10% oily suspension, equivalent to doses of 250, 500, 1000 and 2000 mg/kg test material was undertaken. Afterwards, the animals were observed 8 days for mortality and poisoning syptoms. No mortality at 250 mg/kg bw, but 1/10 at 500 mg/kg and 100% at doses > 1000 mg/kg. Death occurred within 1 - 4 days after exposure. Animals that died showed apathy, impaired balance and inappetence. Surviving animals showed no clinical findings. The mean lethal dose was determined to be 700 mg/kg.
Reference
Table 1: Mortality
Dose [mg/kg] |
Number of animals |
Dead animals |
Time to death [days] |
2000 | 5 | 5/5 | 2-3 |
1000 | 10 | 10/10 | 1-4 |
500 | 10 | 1/10 | 2 |
250 | 10 | 0/5 | - |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 700 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable test method without detailed documentation; reliable experimental data
- Principles of method if other than guideline:
- - Principle of test: 6 male rats were whole body exposed to an aerosol of the test substance for 4 hours. Therefore, the test stubstance was molten to liquify, nebulized under a stream of dry nitrogen and diluted with 20 % oxygen. The animals were observed 7 days for mortality and syptoms of acute intoxication. Animals were examiened for gross pathological and histopathological changes.
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Chr-CD (Charles River-CD)
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charales River.
- Age at study initiation: adult.
- Weight at study initiation: 250-275 grams. - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: nitrogen stream diluted with 20 % oxygen
- Remark on MMAD/GSD:
- particel size distribution not specified
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: boroilicate glass bell jars.
- Exposure chamber volume: 18 liter.
- System of generating particulates/aerosols: The test substance was nmelted in a glass flask and the molten material maintained at 90-115°C under dry, prepurified nitrogen . It was nebulized with a stainless steel nebulizer. Immediately prior
to entering the exposure chamber, the nitrogen-diluted stream of each material under study was again diluted with cylinder oxygen to an oxygen content of 20% (v/v) .
TEST ATMOSPHERE
- Brief description of analytical method used: Atmospheric samples were collected in an evacuated gas-sampling bulb of known volume. The sample was quantitatively transferred from the bulb with absolute alcohol and the washings diluted to a known volume. To calculate test substance concentrations, the O.D. of this solution was determined at 260 nm. The lower limit of quantitative detection by this method was 1.9 moles (500 ug) of test substance. The standard curve was linear for the ranges of concentrations used. Chamber atmospheres were analyzed at least hourly. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- not specified
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: not specified
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology, histopathology - Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 12.5 mg/L air
- 95% CL:
- >= 8.6 - <= 18.2
- Exp. duration:
- 4 h
- Remarks on result:
- other: 32.6 - 69.6 μmol/l
- Mortality:
- No individual data on mortality available.
- Clinical signs:
- other: Clinical signs were typical of respiratory irritation: red ears, salivation, lacrimation, facepawing and dyspnea.
- Gross pathology:
- No macroscopic or histopathological findings.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LC50 = 12.5 mg/L
- Executive summary:
Six male rats were whole body exposed to an aerosol of the test substance for 4 hours. Therefore, the test stubstance was molten to liquify, nebulized under a stream of dry nitrogen and diluted with 20 % oxygen prior to entering the exposure chamber. The animals were observed 7 days for mortality and syptoms of acute intoxication. Animals were examiened for gross pathological and histopathological changes. The animals showed clinical signs typical of respiratory irritation: red ears, salivation, lacrimation, facepawing and dyspnea. No macroscopic or histopathological effects were observed. No individual data on mortality were reported, however, a LC50 of 12.5 mg/L was stated.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 12 500 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: test procedure in accordance with generally accepted standard methods
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: The acute dermal toxicity to rabbits was evaluated according to a BASF-internal standard method by a single application of an 50% alcoholic suspension to the shaven dorsal skin of 3 male and 3 female animals, equivalent to a dose of 4000 mg/kg test material. During 24 hour exposure period, the exposed skin area of 355 cm2 was covered with parchment paper and overlying bandages and the animals were restrained. After application, the animals were observed for 14 days for mortality and syptoms of acute intoxication or local irritation. Animals were evaluated for gross pathological changes. The mean lethal dose was determined
- GLP compliance:
- no
- Limit test:
- yes
- Specific details on test material used for the study:
- - Purity: 99%
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final dilution of a dissolved solid, stock liquid or gel: 50% alcoholic suspension
FORM AS APPLIED IN THE TEST (if different from that of starting material): suspension - Species:
- rabbit
- Strain:
- Vienna White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: 2/6 bred by the medical-biological research laboratory of BASF, 4/6 purchased.
- Weight at study initiation: average 3,24 kg.
- Diet (e.g. ad libitum): yes.
- Water (e.g. ad libitum): yes.
IN-LIFE DATES: From: 14.10.1971 To: 28.10.1971. - Type of coverage:
- occlusive
- Vehicle:
- ethanol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 355 cm2.
- Type of wrap if used: the application area was covered with parchment paper and overlying bandages.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx. 10 mL.
- Concentration (if solution): 50 %. - Duration of exposure:
- 24 hours
- Doses:
- 4000 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: at least after 1h, 24h, 48h, 7d and 14d.
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical signs, signs of local irritation. - Sex:
- male/female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 4 000 mg/kg bw
- Remarks on result:
- other: no mortalities
- Mortality:
- No mortalities occured.
- Clinical signs:
- other: No signs of acute intoxication and local irritation were observed.
- Gross pathology:
- Necropsy revealed no macroscopic and/or organ pathological findings related to TS exposure.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 > 4000 mg/kg
- Executive summary:
The acute dermal toxicity of the test substance to rabbits was assessed according to a BASF-internal standard method. Therefore, the test substance was applied as an 50% alcoholic suspension to the shaven backs of 6 rabbits for 24 hours, equivalent to a dose of 4000 mg/kg test substance . During a 14-day observation period, mortality, signs of acute intoxication or local irritation were recorded. Pathological changes were evaluated in all animals. No mortalities occured. No signs of acute intoxication and local irritation were observed. Necropsy revealed no macroscopic and/or organ pathological findings related to test substance exposure. Therefore the dermal LD50 was determined to be > 4000 mg/kg.
Reference
Table 1: Mortality
Dose [mg/kg] |
Concentration in alcohol [%] |
Number of animals |
Dead animals within | ||||
1 hour | 24 hours | 48 hours | 7 days | 14 days | |||
4000 | 50 | 3 male 3 female |
0 / 3 0 / 3 |
0 / 3 0 / 3 |
0 / 3 0 / 3 |
0 / 3 0 / 3 |
0 / 3 0 / 3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 000 mg/kg bw
Additional information
Acute oral toxicity:
The LD50 of the test substance in rats was > 6400 mg/kg bw, when administered as aqueous suspension in tragacanth (BASF, 1970) and 700 mg/kg bw, when administered in olive oil (BASF, 1952). Animals that died showed apathy, impaired balance and inappetence. Surviving animals showed no clinical symptoms.
In line with the results in rats, a clear vehicle dependence was observed in studies with rabbits (BASF, 1972), too. Mortality occured at lower concentrations of the oily preparation (2000 mg/kg, olive oil) compared to the aqueous suspension (4000 mg/kg, carboxymethylcellulose) and clinical signs were more pronounced when given in olive oil. Clinical effects included ataxia, ventral/lateral positioning, inappetence and weight loss.
In a study on mice (BASF, 1952) a variable death pattern was observed with 0/5 deaths at 125 mg/kg, 4/5 at 250 mg/kg, 2/5 at 500 mg/kg, 5/5 at 1000 mg/kg, 3/5 at 2000 mg/kg and 5/5 at 4000 mg/kg test substance suspended in olive oil. Animals that died showed accelerated respiration, tonic-clonic seizures and jumping seizures approximately 30 minutes after application. No clinical findings in all surviving animals.
Two Beagle dogs survived a single dose of 1200 mg/kg bw (administered in aqueous traganth) with transient diarrhea as the main clinical sign. None of four animals died after a dose of 1200 mg/kg bw, administered as 40% suspension in olive oil, while one of two dogs died after a dose of 600 mg/kg bw in olive oil. The surviving animal suffered from ataxia and impaired balance two days after the administration (BASF, 1972).
Acute inhalation toxicity:
The 4-hr LC50 of the test substance in rats was determined to be 12500 mg/m3 (whole-body exposure) (Waritz, 1975). No individual data on mortalities were given in this publication. Clinical signs during exposure were typical of respiratory irritation and included salivation, lacrymation, dyspnea, and red ears. No effects were reported at macroscopic examination including organ weights.
BASF (1971) reported an inhalation hazard test. Rats were exposed for up to 8 hours to air streams loaded with the volantiles arising from tempering the test substance either to 20°C or 200°C. Concentrations were not measured but estimated to be 20 mg/m3 (20°C) and 35000 - 90000 mg/m3 (200°C) based on the substance loss and air flow rate. (Avoidance reaction, severe irritation of mucous membranes and trembling were reported for animals treated with aerosols generated at 200°C. All animals survived a single exposure for 8 hours when the test substance was tempered to 20°C, whereas 1/6 and 1/12 animals died after 3 and 8 hours exposures when the test substance was heated up to 200°C. Deceased animals showed cardiac dilatation, hyperemic congestion in lung and liver, lung emphysema and hyperemia (8- and 3 -hour exposure). The exposure concentrations were estimated to be
Acute dermal toxicity:
In rabbits, the LD50 of the test substance administered as a 50% alcoholic solution under occlusive conditions was > 4000 mg/kg bw (BASF, 1971). No mortality, systemic toxicity or local irritation was noted, no pathological changes were found at necropsy.
In rats, the LD50 of test substance (administered as a 50% alcoholic solution) was > 2500 mg/kg bw (BASF, 1971). The type of coverage (occlusion) was not specified in this study. No systemic toxicity or local irritation was noted. 1/20 (female) died within 24 hours after administration without any obvious clinical symptoms. At necropsy, this animal showed liver congestion, and bloody, gel-like contents of the intestine. No signs of acute intoxication, local irritation or pathological changes were found in the surviving animals.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for acute oral toxicity Cat. 4 under Regulation (EC) No. 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776. The substance is not considered to be classified for acute dermal or inhalative toxicity.
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.