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EC number: 223-362-3 | CAS number: 3855-32-1
- 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 = 1598 mg/kg
Inhalation LC50 = 1480 mg/m³
Dermal LD50 = 569 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study preceeds current OECD guidelines, however is equivalent to OECD Guideline 404 (Acute Dermal Irritation / Corrosion). No GLP, however the study is sufficiently reported and the results unambiguous.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- other: Rat and Mouse
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Control animals:
- no
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2.37 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Male Rat
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2.3 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2.09 - <= 2.51
- Remarks on result:
- other: Female rat
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 2.19 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1.97 - <= 2.46
- Remarks on result:
- other: Male Mouse
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1.68 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1.49 - <= 1.87
- Remarks on result:
- other: Female Mouse
- Mortality:
- Obsrved in all treated groups.
- Clinical signs:
- other: Decreased activity, ataxia, dyspnea and writhing
- Other findings:
- Signs of toxicity were observed immediately after treatment and jpersisted les than 24 hours post-treatment (corrosive)
- Interpretation of results:
- moderately toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Rat - Acute Oral Toxicity LD50 1598 mg/kg
The substance is severely irritating and corrosive to the skin and eyes. This material is irritating and corrosive to the nasal and respiratory tract
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 598 mg/kg bw
- Quality of whole database:
- Reliable with restrictions.
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: The study was not performd to GLP and reporting of methods is sparse. However, the study outcomes are unambiguous and predictable. Therefore the study is deeemd sufficiently reliable.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Whole-body exposure.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- other: Charles River rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Young adult albino rats were employed as test animals. The rats were selected after having been under observation for at least 5 days to insure their general health and suitability for testing. The animals were housed in stainless steel cages and permitted a standard laboratory diet plus .water
ad libitum, except during inhalation exposure. - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- clean air
- Details on inhalation exposure:
- Vapour was generated by passing a stream of clen, dry air through the diluted test material in a gas washing bottle. The resulting air/vapour mixture ws then introduced to the exposure chamber.
- Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- ca. 14 d
- Remarks on duration:
- Whole-body exposure.
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LC50
- Remarks on result:
- other: No effects attributable to the test material were observed
- Mortality:
- None observed
- Clinical signs:
- other: None observed
- Body weight:
- No changes observerd outside of normal ranges
- Gross pathology:
- No gross effect reported
- Interpretation of results:
- sligthly toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- There were no adverse reactions noted during exposure or the 14-day observaticn period which followed. The average 2- week body weight gains were within the normal limits.
The LC50 was calculated as >1.48 mg/L (rat) 1-hr. (no deaths)
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 1 480
- Quality of whole database:
- Reliable with restrictions.
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was coinducted according to OECD Guideline 402 (Acute Dermal Toxicity). The substance was administered to five rats of each sex by dermal application.. NA GLP certificate is provided. The study is otherwise well documented.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The substance was administered to five rats of each sex by dermal application at 2000, 1000 or 400 mg.kg body weight for 24 hours.
- Duration of exposure:
- 24 hours.
- Doses:
- Dermal application at 2000, 1000 or 400 mg.kg
- No. of animals per sex per dose:
- 5 males
5 Females - Control animals:
- not specified
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1.2 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1.01 - <= 2.01
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1.25 mL/kg bw
- Based on:
- test mat.
- Mortality:
- The incidence of mortality among both sexes from high to low dose group was 10, 10 and 0.
- Clinical signs:
- other: Hyperactivity and lethargy were noted in all animals. Prostration, bradypnoea, piloerection, ptosis, squealing and lacrimation were noted among the animals. These symptoms had disappeared in all surviving animals by day 5, although temporary piloerection
- Gross pathology:
- The treated skin surface among the animals showed oedema, necrosis, erythema, crusts, scaliness, a wound and new skin formation.
Macroscopic post iuortem examination of the animals that died during the study revealed greenish discolouration of the treated area, red spot in the treated area, dark redlblacklpurple colouration of the dermis beneath the treated
area, dark red colouration of the muscles under the treated area, black areas in glandular stomach, red coloured lungs and reddish liquid fn thoracic cavity. These findings were considered treatment related and toxicological significant.
Macroscopic post mortem examination of the surviving animals at termination revealed scab formation on the treated skin area, reduced seminal vesicles and thickened, grey, hard left testes grown together with the epididymis. - Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 value in rats was determined to be 569 mg/kg bw for the sexes combined.
Due to the mortality distribution alone estimated dermal LD50 values could be calculated for males and females alone. These amounted to 569 mg/kg body weight for males alone and 569 mg/kg body weight for females alone.
Based on the results, and according to EU Directive 67/548/EEC, the substance should be classified as harmful.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 569 mg/kg bw
- Quality of whole database:
- Reliable with restrictions.
Additional information
The substance is severely irritating and corrosive to the skin and eyes. This material is irritating and corrosive to the nasal and respiratory tract.
Rat - Acute Oral Toxicity LD50 1598 mg/kg.
Justification for selection of acute toxicity – oral endpoint
In an acute oral toxicity study in rats, the substance was
determined to have an Acute Oral LD50 of 1598 mg/kg.
Justification for selection of acute toxicity – inhalation endpoint
In a whole-body vapour inhalation test in rats, vapour was generated
by passing a stream of clean, dry air through the diluted test material
in a gas washing bottle. The resulting air/vapour mixture was then
introduced to the exposure chamber.
After 1 hour no deaths were reported.
The LC50 was determined as >1.48 mg/L (rat) 1-hr. (no deaths).
The substance is mildly toxic by inhalation.
Justification for selection of acute toxicity – dermal endpoint
The dermal LD50 value of the substance in rats amounted to 569 mg/kg
bw for the sexes combined.
In a supporting study, there was clear evidence of skin corrosion.
Based on the results, and according to EU Directive 67/548/EEC, Polycat
77 should be classified as harmful to the skin.
Justification for classification or non-classification
Based on the result of studies and according to the criteria of the CLP Regulation the substance should be classified as category 4 acute oral toxicant, H302 and category 3 acute dermal toxicant, H311. According to the criteria of the DSD Regulation, the substance is classified as Xn R22 and Xn R21, respectively. The substance should not be classified for acute toxicity via inhalation routes according to the DSD and CLP criteria.
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.
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