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EC number: 202-908-4 | CAS number: 101-02-0
- 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
Acute oral toxicity: LD50 = 1590/1630 mg/kg bw (m/f); rat, similar to OECD TG 401, non-GLP, K2
Acute inhalation toxicity: LC50 > 6.7 mg/L air (m/f); 1 h exposure, rat, similar to OECD TG 403, non-GLP, K2
Acute dermal toxicity: LD50 > 5000 mg/kg bw (m/f); rat, non-guidline, non-GLP, K2
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:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Study performed according to Section 1500.3 Federal Hazardous Substances Act Regulations - 16 CFR - P. 114.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Sherman-Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200 and 300 g
- Fasting period before study: yes, overnight
- Housing: in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3.
- Diet: ad libitum
- Water: ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- males: 1000, 1260, 1410, 1580, 2000, 2510, 3160, 3980 mg/kg bw
females: 1000, 1260, 1580, 1780, 2000, 2510, 3160, 3980 mg/kg bw - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 21 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- The LD50 was calculated employing the method described in the following publication: Finney, D. J. Statistical Methods in Biological Assay, Second Edition, London Griffin Press 1971.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 590 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 630 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All male animals of dose groups 2000 mg/kg and higher died on the first day. At 1580 mg/kg, 2 males died, and at 1410 mg/kg, one male died.
All female animals of dose groups 2000 mg/kg and higher died on the first day. At 1780 mg/kg, 3 females died. At 1580 and at 1260 mg/kg one female died. - Clinical signs:
- other: Males: At lower dose levels animals were slightly depressed and ruffled. At 1580 mg/kg the animals were moderately depressed, ruffled and drooling. Several aninals became severely depressed and/or seni-comatose after 3-4 hours. These effects were reversi
- Gross pathology:
- Gross pathologic examination revealed nothing remarkable.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on the results of this acute oral toxicity study in Sherman-Wistar rats, the LD50 was set to 1590 mg/kg bw for males and 1630 mg/kg bw for females.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 590 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:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200-210 average weights
- Housing: in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3. - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- not specified
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: plexiglass exposure chamber
- Exposure chamber volume: 260 l
- Method of holding animals in test chamber:
- Source and rate of air: 20 liters per minute
- System of generating particulates/aerosols: six jet Collision nebulizer (BGI Incorporated, Waltham, Mass.). The air was passed through a desleant prior to being passed through the test material
- Method of particle size determination: Andersen Sampler cascade impactor. From these values the mass median diameter of the aerosol was calculated to be 0.73 microns and the concentration was calculated to be 0.10 mg/L.
- Temperature, humidity, pressure in air chamber: 70°F - Duration of exposure:
- 1 h
- Concentrations:
- 6.7 mg/liter
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 21
- Frequency of weighing: day 0 and day 21
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 6.7 mg/L air (nominal)
- Exp. duration:
- 1 h
- Mortality:
- No mortalities occurred.
- Clinical signs:
- other: No adverse effects were observed during the one hour exposure period. No untoward symptoms were observed during the three week post exposure observation period.
- Body weight:
- The animals gained weight during the course of the study.
- Gross pathology:
- Gross pathologic examination revealed nothing remarkable.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on the results of this inhalative acute toxicity study in rat, the LC50 was found to be > 6.7 mg/L air. Since the exposure duration was only 1h, the concentrations analysed were too low to conclude on a classification.
Reference
Andersen Sampler:
Concentration = 0.24 mg/liter
Particle size = 0.73µ MMD (mass median diameter)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- > 6.7 mg/L air
- Physical form:
- inhalation: aerosol
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:
- 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method from Noakes and Sanderson, Brit. J. Ind. Med. 26, 59, 1969
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks - Duration of exposure:
- 24 h
- Doses:
- 5 ml/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- other: control animals were treated with 90% Phenol
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- 1 male animal died
- Clinical signs:
- other: The animal that died displayed a bad general health. All other animals were free of symptoms.
- Gross pathology:
- nephrosis, skin degeneration
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this dermal acute toxicity study in rat, the LD50 was found to be > 5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 5 000 mg/kg bw
Additional information
Acute oral toxicity
In an acute oral toxicity study (K2, non-GLP, similar to OECD 401; Biosearch 1980) the test substance was administered at doses of 1000, 1260, 1410, 1580, 2000, 2510, 3160, 3980 mg/kg bw (males) and 1000, 1260, 1580, 1780, 2000, 2510, 3160, 3980 mg/kg bw (females) to 5 animals/sex/dose. The observation period following administration was 21 d. Based on the results of this acute oral toxicity study in Sherman-Wistar rats, the LD50 was set to 1590 mg/kg bw for males and 1630 mg/kg bw for females.
Acute inhalative toxicity
In an acute inhalative toxicity study (K2, non-GLP, similar to OECD 403; Biosearch 1980) 5 female and 5 male rats were exposed to 6.7 mg/L air test substance for 1h. The observation period following administration was 21 d. No mortality occured, thus, the LC50 was > 6.7 mg/L air for 1h exposure for males and females. Extrapolating the results to an exposure duration of 4h by applying the haber's rule, the LC50 is > 1,675. This concentration is too low to conclude on a classification.
Acute dermal toxicity
In an acute dermal toxicity study (K2, non-GLP; BASF 1970) 5 mg/kg test substance was administered on the back and flank of Srague-Dawley rats for 24h with 10 animals/sex/dose. It is not specified if the test substance was removed afterwards. The observation period following administration was 14 d. As only one male died, the LD50 was found to be > 5000 mg/kg bw (m/f).
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. For dermal toxicity, the LD50 value did not meet the classification criteria. Following oral dosing in rats, mortality occurred with an LD50 of about 1590 mg/kg bw. As a result, the substance is considered to be classified for acute toxicity Cat. 4 under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.
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