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EC number: 423-270-5 | CAS number: 164462-16-2
- 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
In an acute oral toxicity study (EU method B.1 & GLP) an LD50 > 2000 mg/kg bw was determined (BASF, 10A0059/951012, 1995).
In an acute dermal study (OECD guideline 402 & GLP) an LD50 > 2000 mg/kg bw was determined (BASF, 11A0059/951013, 1995).
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3043/V9Z
- physical state at ambient conditions: solid - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Animal species: rat / wistar / chbb: thom (SPF)
- Animal breeder: Dr. K. Thomae GmbH, Biberach, Germany
- Age of the animals: young adult animals.
- Animal weights at start of the study: animals of comparable weight; (150g - 300g) (+/- 20 % of the mean weight).
- Animal identification: individual identification using cage cards and group identification by tail marking.
- Room temperature/Relative humidity: the animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 - 24 degrees Celsius for temperature and of 30.- 70 % for relative humidity. There were no deviations from these ranges which influenced the results of the study.
- Day/night rhythm: 12 h/12 h (6.00 a.m. - 6.00 p.m./ 6.00 p.m. - 6.00 a.m.)
- Type of cage: stainless steel wire mesh gages, type DK-III (Becker & Co., Castrop-Rauxel, Germany)
- No. of animals per cage: single housing.
- Bedding: no bedding in the gages; sawdust in the waste trays.
- Drinking water: tap water ad libitum per day.
- Diet: Kliba-Labordiaet 343, Klingentalmuehle AG Kaiseraugst, Switzerland, ad libitum.
Analysis of drinking water:
The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the technical services of BASF AG as well as for the presence of germs by a contract laboratory.
Analysis of feed:
The feed used in the study was assayed for chemical and microbiological contaminants. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- FASTING OF ANIMALS:
-16 h before administration of test substance, water available ad libitum
VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: aqueous formulation corresponds to physiological medium.
- Stability of test substance: Test substance stable in drinking water for at least 4 days
CLASS METHOD
- Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance, no pronounced acute oral toxicity was expected. Therefore a dose of 2000 mg/kg bw was selected as starting dose. - Doses:
- 2000 mg/kg b.w.
- 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 and weighing: observations were recorded several times at the day of administration and at least once daily thereafter. Animals were weighed at day 0 before administration and once weekly thereafter.
- Necropsy of survivors performed: yes, fasting of animals 16 h before sacrifice
- Other examinations performed: clinical signs, body weight - Statistics:
- none
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Female animals: 3 animals displayed impaired general state, dyspnoe, staggering and piloerection. All symptoms were reversible until 3 days post application. Male animals: no abnormalities.
- Gross pathology:
- No abnormalities noted at necropsy of animals sacrificed at the end of the study.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and guideline study.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
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:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3043/V9Z - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- -Animal species: rat / wistar / chbb: thom (SPF)
- Animal breeder: Dr. K. Thomae GmbH, Biberach, Germany
- Age of the animals: young adult animals.
- Animal weights at start of the study: animals of comparable weight; (200g - 300g) (+/- 20 % of the mean weight).
- Animal identification: individual identification using cage cards and group identification by tail marking.
- Room temperature/ Relative humidity: fully air-conditioned rooms. 20-24 degrees Celsius and of 30 -70 % for relative humidity.
- Day/night rhythm: 12 h/12 h (6.00 a.m. - 6.00 p.m./ 6.00 p.m. - 6.00 a.m.)
- Type of cage: stainless steel wire mese cages, type DK-III (Becker & co., Castrop-Rauxel, Germany)
- No. of animals per cage: single housing.
- Bedding: no bedding in tee cages; sawdust in the waste trays.
- Drinking water: tap water ad libitum per day.
- Diet: Kliba Labordiaet 343, Klingenthalmuehle AG Kaiseraugst, Switzerland, ad libitum.
Analysis of drinking water:
The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the tecenical services of BASF AG as well as for the presence of germs by a contract laboratory.
Analysis of feed:
The feed used in the study was assayed for chemical and microbiological contaminants. - Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal an dorsolateral parts of the trunk; about 50 cm2
- Type of wrap if used: the bandage consists of four layers absorbent gauze, Ph. Eur. Lohmann GmbH & Co. Kg and Fixomull stretch (adhesive fleece), Beiersdorf AG)
REMOVAL OF TEST SUBSTANCE
- Washing: rinsed with water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 2000 mg/kg bw
- Concentration: 0.5 g/mL
- Constant volume or concentration used: yes, constant concentration
- For solids, paste formed: yes (suspension)
VEHICLE
- Amount applied: 4 mL/kg
- Stability of test substance in vehicle: substance is stable in tap water for at least 4 days in a concentration of 1 mg/mL - Duration of exposure:
- single exposure
- Doses:
- 2000 mg/kg b.w.
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals;
- Frequency of weighing: Individual body weights shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period).
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No signs of systemic toxicity could be noticed. Cageside observtions did not reveal any signs of toxicity. The following local effects were reported: females: 2 animals depicted well-defined erythema at study day 1 and another 2 animals displayed slight e
- Gross pathology:
- No abnormalities were noted at necropsy of animals sacrificed at the end of the study.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and guideline study.
Additional information
To assess acute oral toxicity of the test item (BASF, 10A0059/941012, 1995) a single dose of 2000 mg/kg bw (vehicle: water) was applied in a limit test according to GLP and EU Method B.1.
No mortality occured within the timeframe of the study and the body weights remained unaffected. Necropsy did not reveal any abnormalities. These results are confirmed by a supporting study using the liquid test item as test substance (BASF, 10A0107/941029, 1995). Overall, under the chosen test conditions, the test item was not toxic after single oral administration:
Oral LD50 > 2000 mg/kg bw
As a second exposure route, acute dermal toxicity was monitored (BASF, 11A0059/951013, 1995). The study applied the Standard Acute Method using a single dose of 2000 mg/kg bw (vehicle: water) in a limit test according to GLP and OECD guideline 402.
No mortality occured within the timeframe of the study, no clinical signs of systemic toxicity were reported and the body weights remained unaffected. Necropsy did not reveal any abnormalities. Test animals displayed local signs of irritation: the majority of males and females displayed well defined erythemas at the site of contact which regressed quicker in males (within 3 days) than in females (within 8 days). Overall, under the chosen test conditions, the test item does not have toxic properties in case of single dermal exposure:
Dermal LD50 > 2000 mg/kg bw
The test item was not assayed for acute inhalative toxicity. However, an acute inhalative study on the structurally closely related compound trisodium nitriloacetic acid (CAS 5064-31-3) does not indicate significant toxicity.
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. The LD50 was
greater than 2000 mg/kg bw. As a result the substance is not considered
to be classified for acute oral or dermal toxicity under Regulation (EC)
No 1272/2008, as amended for the eighth time in Regulation (EU) No
2016/218.
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