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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 221-029-7 | CAS number: 2978-58-7
- 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 acute oral LD50 was determined to be 1470.0 mg/kg bw in rats.
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:
- 1969-05-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- In principle, the methods described in OECD Guideline 401 (Acute Oral Toxicity) were used.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- - Purity: assumed to contain 100% active ingredient
- Appearance: clear, colorless liquid, pungent odor
- Date received:1969-03-25 - Species:
- rat
- Strain:
- other: Carworth (Sprague-Dawley-derived) strain
- Sex:
- male
- Route of administration:
- other: gastric intubation
- Vehicle:
- water
- Details on oral exposure:
- After a three to four-hour fasting period, the test material was administered by gastric intubation as a 50% weight-per-volume suspension in distilled water to groups of five male rats each at dosage levels of 100, 215, 464, 1000 and 2150 mg/kg of body weight.
- Doses:
- 100, 215, 464, 1000, 2150, and 4640 mg/kg bw
- No. of animals per sex per dose:
- 5 males per dose
- Control animals:
- no
- Details on study design:
- - Fasting period: three to four hours before exposure
- Diet (postdose): Purina Laboratory Chow and water available ad libitum
- Frequency of weighing: initially and terminally
- Frequency of observations on mortality and toxic effects: 1, 4 and 24 hours after dosing; once daily thereafter
- Necropsy of survivors performed: yes (on all animals which died during the study or were sacrificed at termination)
- Other examinations performed: clinical signs
- Duration of observation period following administration: 7 days
- Sacrifice: barbiturate (Diabutal) overdose after observation period - Statistics:
- Analysis of mortality data was performed according to Thompson, W. R., Bact. Rev. 11, 115-145, 1947, using the tables of Horn, H. J., Biometrics 11, 311, 1956. No confidence limits were determined due to "all-or-none" response.
- Preliminary study:
- Not performed.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 470 mg/kg bw
- Based on:
- test mat. (dissolved fraction)
- Mortality:
- Five of five male rats died on day four at the 2150 mg/kg bw level.
- Clinical signs:
- other: DOSE-DEPENDEND PRINCIPAL TOXIC EFFECTS - 100 mg/kg bw: no effects - 215 mg/kg bw: slight depression (1-24 hours) - 464 mg/kg bw: slight depression (1-24 hours) - 1000 mg/kg bw: labored respiration, ptosis, lacrimation, ataxia, bloody crust on eyes, and
- Gross pathology:
- AT DEATH
- 2150 mg/kg bw: dark red zone at corticomedullary junction of kidney, stomach distended with dark red fluid, soft consistency of stomach walls, lining of pyloric portion dark red, cardiac portion thickened and pink in color.
AT SACRIFICE
- no gross pathology observed - Interpretation of results:
- Category 4 based on GHS criteria
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1972-10-06
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- In principle, the methods described in OECD TG 401 were used.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- - Concentration: 8% and 16% aqueous solution
- Physical state: liquid - Species:
- rat
- Strain:
- other: Gassner strain
- Sex:
- male/female
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Details on oral exposure:
- aqueous solution
- Doses:
- Single dose of 800, 1000, 1250,1600, 2000, 2500, 3200 or 4000 mg/kg bw
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- no
- Details on study design:
- - Test duration: 14 d
- Frequency of observations: 1 h, 24 h, 48 h, 7 d, 14 d
- Duration of observation period following administration: 14 days
- Necropsy performed: yes
- Other examinations performed: clinical signs, body weight, histopathology - Statistics:
- Graphical evaluation of the dose response curve on probability paper.
- Preliminary study:
- Not performed.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1.7 mL/kg bw
- Based on:
- not specified
- Remarks on result:
- other: no confidence limits determined
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 397.4 mg/kg bw
- Based on:
- not specified
- Remarks on result:
- other: value derived from density at 25 °C noted in Beilstein (2006) (see section 4.4)
- Mortality:
- One hour after application no mortality occured at all dose levels. At dose levels of 800, 1000 and 1250 cmm/kg bw no mortality was observed during the study period neither at male nor at female rats. Five of five male rats died after 24 h at the 4000, 3200 and 2500 cmm/kg bw level. Four of five female rats died after 24 h at the 4000 cmm/kg bw level and five of five female rats dies after 24 hours at the 3200 and 2500 cmm/kg bw level. For details on mortality please see table in "Any other infromation on results incl. tables".
- Clinical signs:
- other: - at all doses and immediately after application: crouching, abdominal position, apathy and irregular respiration - day 4-7: crouching and gasping respiration - after 7 days: all surviving animals unconscious
- Gross pathology:
- - cardiac dilation
- hyperemia
- stomach dilated with thin pulpy contents
- gastritis
- haematized and diarrheal intestinal contents
- liver clay-colored - Interpretation of results:
- Category 4 based on GHS criteria
Referenceopen allclose all
Table 1: Mortality after 1 h, 4 h, 24 h and 2 -7 d due to an initial application of an aqueous solution of the test substance at dose levels of 100, 215, 464, 1000 and 2150 mg/kg bw. Number of animals dead per number of animals tested, cumulative.
Time of Death |
|||||
Dose [mg/kg bw] |
Immediate |
Hours |
Days |
||
1 |
4 |
24 |
2 -7 |
||
100 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
215 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
464 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
1000 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
2150 |
0/5 |
0/5 |
5/5 |
Table: Mortality after 1 h, 24 h, 48 h, 7 d and 14 d due to an initial application of an aqueous solution of the test substance at dose levels of 4000, 3200, 2500, 2000, 1600, 1250, 1000 and 800 cmm / kg bw. Number of animals dead per number of animals tested, cumulative.
Dose [cmm / kg bw] |
Concentration [%] |
Number of animals |
Mortality after |
||||
1 hour |
24 hours |
48 hours |
7 days |
14 days |
|||
4000 |
16 |
5 M |
0/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5 F |
0/5 |
4/5 |
4/5 |
5/5 |
5/5 |
||
3200 |
16 |
5 M |
0/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5 F |
0/5 |
5/5 |
5/5 |
5/5 |
5/5 |
||
2500 |
16 |
5 M |
0/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5 F |
0/5 |
5/5 |
5/5 |
5/5 |
5/5 |
||
2000 |
16 |
5 M |
0/5 |
2/5 |
2/5 |
4/5 |
4/5 |
5 F |
0/5 |
1/5 |
2/5 |
4/5 |
4/5 |
||
1600 |
16 |
5 M |
0/5 |
0/5 |
3/5 |
3/5 |
3/5 |
5 F |
0/5 |
0/5 |
0/5 |
1/5 |
1/5 |
||
1250 |
16 |
5 M |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
5 F |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
||
1000 |
16 |
5 M |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
5 F |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
||
800 |
16 |
5 M |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
5 F |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 470 mg/kg bw
- Quality of whole database:
- The studies were conducted comparable to guideline with sufficient documentation.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
An in vivo study with 6 groups of five male rats (Carworth strain) was carried out according to a method comparabel to OECD Guideline 401 (Dow AgroSciences, DR-0385 - 4500 - 099, 1969). After a fasting period of three to four hours, a 50% aqueous suspension of the test substance was administered by a gastric intubation at dosage levels of 100, 215, 464, 1000 and 2150 mg/kg bw. Both mortality and toxic effects were recorded immediately after dosing and after one, four, 24 hours and once daily thereafter for the period of 7 days. Additionally, gross necropsy was performed on all animals which died during the study and on those euthanized at termination of the experiment. Several unspecific clinical symptoms were observed in increasing intensity with increasing dose. The derived LD50 was 1470 mg/kg bw.
Additionally, an in vivo study (BASF SE, XXI-245, 1972) with low reliability was conducted according to an internal method in order to investigate the acute oral toxicity of the test substance at rats (Gassner strain). After oral application of the test substance, several unspecific clinical symptoms were noted. For the 16% aqueous solution of the test item a LD50 of ca. 1.7 mL/kg bw was derived (after an observation period of 14 days). This value corresponds to a LD50 of 1397.4 mg/kg bw.
The most reliable study is used as key study.
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 (EC) No 1272/2008, as amended for the tenth time in Reguglation (EU) 2017/776. As a result the substance is considered to be classified Category 4 (H302: Harmful if swallowed) for acute oral 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.