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EC number: 265-634-4 | CAS number: 65212-77-3
- 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
Three studies were performed to evaluate acute oral, dermal and inhalative toxicity of the test substance to the
rat (according OECD 401, 402, 403). Neither the test substance nor structural analogues induce mortalities, abnormalities or clinical signs when applied oral or dermal. Also single administration via respiratory system did not cause health effects or mortalities. The LD50 for oral and dermal toxicity is considered to be > 2000 mg/kg bw, LC50 is > 5.5 mg/l air.
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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- (mostly due to reduced reporting in times before GLP), limited data to test substance
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- The application volume was not calculated by the individual weight, but by the mean weight per sex
- Principles of method if other than guideline:
- Standardized test method (BASF-Test)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Acclimatization in the animal care unit for at least 1 week.
Age of the animals at the beginning of the study: about 12 weeks
Type of cage: Stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
No. of animals per cage: 5
Animal identification: Identification of groups (5 animals) using cage cards
Room temperature: 20 - 26°C
Humidity: 45 - 75%
Day/night rhythm: 12 h/12 h (6.00 - 18.00 hours/18.00 - 6.00 hours)
Drinking water: Demineralized water each workday, tap water on holidays; ad libitum
Diet: Ssniff R; SSNIFF, Versuchstierdiaeten, Soest, Germany
Fasting period: The animals are given no feed 16 hours before administration, but water is available ad libitum. - Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% aqueous carboxymethyl cellulose and 1 - 2 drops of Cremophor EL
- Details on oral exposure:
- Aqueous formulation corresponds to the physiological medium.
Form of administration: suspension - Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 14 days
Weight check: Animals of comparable weight (+/- 10 g) in one cage; weighing of groups before administration, 2nd weighing on the 3rd day, 3rd weighing on the 7th day, 4th weighing on the 13th day after administration.
Signs and symptoms: Recording of signs and symptoms < 15 min, 15 min, 30 min, 1 h, 2 h, 4 h and 5 h after administration of the test substance and then once each workday. Check for moribund and dead animals twice each workday and once on holidays.
Pathology: Withdrawal of food 16 hours before sacrifice with C02; then necropsy with gross-pathological examination. Necropsy of all animals that die as early as possible. - Statistics:
- -
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality, no toxicity observed.
- Mortality:
- none
- Clinical signs:
- other: 1 day after treatment: yellow feces
- Gross pathology:
- Sacrificed animals: organs: no abnormalities detected.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 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
- Remarks:
- limited data to test substance
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- No analytical purity; gravimetric analyses of the concentration without analytical confirmation of the composition and reanalysis of the airborne material, respectively; single instead of twice particle size distribution determination.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Mean body weight at the beginning of the test: male animals: 307 +/- 16 g, female animals 228 +/- 17 g.
Age at the beginning of the test: about 8 -10 weeks.
Identification: The animals were identified by toe amputation.
The animals were offered SSNIFF R complete diet for rats and mice, manufacturer: SSNIFF-Versuchstierdiaeten GmbH, Soest, Germany, and tap water ad libitum during the post-exposure observation period.
The animals were accommodated in fully air-conditioned rooms (required temperature 22 + 20°C, required humidity 55 + 5%) with a light/dark rhythm of 12 hours. They were housed in groups of five in cages of Becker, type D III, without bedding. - Route of administration:
- inhalation: mixture of vapour and aerosol / mist
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- air
- Details on inhalation exposure:
- Head-nose inhalation system INA 20 (glass/steel construction, BASF Aktiengesellschaft, V ca. 55 l); the animals are restrained in tubes and their snouts project into the inhalation chamber.
A mixture of dust and air was generated by means of a vibration aerosol generator (fluidized bed).
By means of a dust generator the substance to be tested was generated into a dust aerosol, which was passed into the inhalation system.
A vibration aerosol generator was used for generating dust. The concentration was adjusted by varying the amplitude and frequency of the vibrator.
The rate of flow was adjusted as follows: 1500 l/h of compressed air through the vibrator.
The inhalation mixture was offered to the animals for inhalation for 4 hours.
By means of an exhaust air system the pressure ratios in the inhalation chamber were adjusted in such a way that the amount of fresh air was about 10% lower. This ensured that the mixture of test substance and air was not diluted by laboratory air in the breathing zones of the animals. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.5 mg/l
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before starting the study, after 7 days and after the end of the observation period
- Necropsy of survivors performed: yes - Statistics:
- The statistical evaluation of the concentration-response relationship was carried out in accordance with the binominal test (Wittig, H.: Mathematische Statistik 1974, pp. 32 - 35) according to tables of the BASF Computer Center.
The particle size was determined in the Department of Toxicology of BASF Aktiengesellschaft in accordance with mathematical and graphical methods of evaluating particle measurements (Silverman, L.: Particle Size Analysis in Industrial Hygiene, 1971, pp. 235-259). - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.5 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: No mortality.
- Mortality:
- none
- Clinical signs:
- other: During exposure: substance-colored fur in the region of the head. After exposure: substance-colored fur, partly agitated behavior, after 1 day nothing abnormal detected.
- Body weight:
- Mean body weight:
Test animals; before start of the study: 307 g (males), 228 g (females); after 7 days: 341 g (males), 241 g (females); after 14 days: 370 g (males), 252 g (females)
Control animals: before start of the study 307 g (males), 230 g (females); after 7 days 340 g (males), 240 g (females); after 14 days 370 g (males), 249 g (females)
The body weight of the animals showed no adverse effects in comparison with that of the control. - Gross pathology:
- Sacrificed animals: no abnormalities detected.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5.5 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- other: Read-across
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Procedure and observations
To evaluate the acute oral toxicity, a single dose (5000 mg/kg bw) of the test article was administrated to a group of 5 male and 5 female rats by oral gavage (BASF AG 1981a). Following dosing, the animals were observed for 14d. Examination of clinical signs and viability were performed daily, weighing on day 1, 3, 7 and 13 after treatment. There were no deaths as a result of treatment with the test article. Clinical signs of toxicity or changes in body weight gain were not observed during the observation period. Gross necropsy was without any findings.
To evaluate the acute inhalative toxicity, male and female rats (10/sex/dose) were exposed for 4h to a dust aerosol (5.5 mg/l air, 1.500 l/h, nose only) of the test item (BASF AG 1982a). Following dosing, the animals were observed for 14d. Examination of clinical signs and viability were performed daily, weighing on day 1, 3, 7 and 13 after treatment. There were no deaths as a result of treatment with the test article. Clinical signs of toxicity or changes in body weight gain were not observed during the observation period. Gross necropsy was without any findings.
read across EC 416-730-1
The test item was not tested for acute dermal toxicity. It is acceptable to derive the dermal toxicity from experimental data of a structural analogue (di-ammonium salt) since both are salts with comparable structures. In addition, lower solubility and the higher molecular weight of the test item give a safety margin (a detailed read across justification is given in CSR, Annex I)
Dermal toxicity of an analogue the di-ammonium salt was evaluated on a group of five male and 5 female rats which were treated with the test article at 2000 mg/kg by dermal application (Ciba 1994a). The substance was suspended in water at a concentration of 0.5 g/ml and administered at a volume of 4 ml/kg. Four times during day 1 and once daily during days 2-15 the animals were examined for clinical signs and viability. Body weights were recorded on day 1 before administration and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study period. Neither clinical signs of systemic toxicity nor local effects of the test article on the skin at the application site were observed during the observation period. After treatment, a residual yellow staining on skin was seen. A slightly lower bodyweight gain was recorded for one male and one female on Day 8 and in three males on Day 15. All other rats achieved the anticipated bodyweight gains throughout the study. Macroscopic organ findings were not observed at necropsy.
In addition to the regular acute toxicity testing, toxicity after intraperitoneal application according an internal guideline was performed (BASF AG 1981b). 5 male and female rats received 2000 mg/kg bw (10 ml/kg bw) of the test item dissolved in 0.5% CMC plus castor oil by intrapritoneal injection. The animals were observed for 14d post treatment and were weighted on days 2, 7 and 13. Apathy and dyspnea were observed after treatment and animals were of poor general state. Mortalities did not occur. Gross necropsy revealed intraabdominal incorporations of the test substance
Discussion
Application of the test substance via oral or inhalative route did not induce any signs of toxicity. None of the animals died, viability and bodyweight gain were unaffected by the test article. Also dermal application of the di-ammonium salt (structural analogue) did not induce any symptoms or mortalities. Intraperitoneal injection of the test item resulted in a poor general state and symptoms commonly seen after intraperitoneal administration. The effects are, therefore, regarded as not-treatment related. In addition, from todays perspective the study does not meet basic scientific criteria and toxicological relevance.
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 not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Commission Regulation (EU) 2018/1480 of Oct 4 2018.
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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