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EC number: 235-558-6 | CAS number: 12286-66-7
- 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
Oral: LD50 (m/f) > 10 000 mg/kg bw, similar to OECD TG 401, no GLP, rat, 1972, K2
Dermal: Read-across, LD50 (m/f) > 2 000 mg/kg bw, according to OECD TG 402, GLP-compliance, rat, 2011, K1
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
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- similarities to OECD guideline 401
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: CFE (RAC, SPF) strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: /
- Age at study initiation: /
- Weight at study initiation: 126 - 139 g
- Fasting period before study: /
- Housing: groups of 5 in macrolon cages
- Diet (e.g. ad libitum): Nafag ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 5
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 14h - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5 % in tap water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25%
- total volume: 20 ml/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10.000 mg/kg bw - Doses:
- 5000 and 10000 mg/kg bw
- No. of animals per sex per dose:
- 5000 mg/kg bw : 5 per sex and dose
10000 mg/kg bw : 3 males and 2 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 8d
- Frequency of observations and weighing: /
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology - Statistics:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- no martality
- Clinical signs:
- other: no clinical symptoms
- Other findings:
- yellow stained feces
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 was established to be > 10000 mg/kg bw.
- Executive summary:
To evaluate the acute oral toxicity, single doses of 5000 and 10.000 mg/kg bw of the test article in 0.5 % carboxymethyl cellulose were administrated to groups of male and female rats (CFE (RAC, SPF) strain) by oral gavage. Following dosing, the animals were observed for 8d. There were no deaths observed after treatment with the test article. Clinical signs of toxicity or changes in body weight gain were not observed. Gross necropsy was without any findings.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Further information are included as attachment in chapter 13 of the IUCLID dossier.
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- 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
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeding farm VELAZ S.f.O., Kolec u Kladna, Czech Republic, RCH CZ 21760152
- Weight at study initiation: males 258 g, females 189 g
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: 10
- Type of wrap if used: semiocclusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution):
- Constant volume or concentration used: unchanged substance, constant dose level, volume individual
- For solids, paste formed: no
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing before application, 8th and 15th day of study, observation daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- no
- Clinical signs:
- other: no
- Gross pathology:
- no abnormalities
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the results of study, the value of LD50 (dermal) of the test substance is higher than 2000 mg/kg bw for rats of both sexes.
- Executive summary:
The substance was tested for acute dermal toxicity using Wistar rats. Two groups of animals (5 males and 5 females) received a single dose of 2000 mg/kg bw. The test material was applied onto shaved dorsal skin for 24 hours. The test animals were observed 14 days after exposure of the test substance, afterwards they were sacrificed, and the necropsy for macroscopic examination of the organs was performed. The test item did not cause mortality. Clinical signs or macroscopic changes were not observed.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute oral toxicity
To evaluate the acute oral toxicity, single doses of 5000 and 10.000 mg/kg bw of the test article in 0.5 % carboxymethyl cellulose were administrated to groups of male and female rats (CFE (RAC, SPF) strain) by oral gavage. Following dosing, the animals were observed for 8d. There were no deaths observed after treatment with the test article. Clinical signs of toxicity or changes in body weight gain were not observed. Gross necropsy was without any findings.
Acute dermal toxicity
As no reliable data on acute dermal toxicity was available for the test substance, a read-across to a study with a structural anologue (CAS 12286-65-6) was performed.
The structural analogue substance was tested for acute dermal toxicity using Wistar rats. Two groups of animals (5 males and 5 females) received a single dose of 2000 mg/kg bw. The test material was applied onto shaved dorsal skin for 24 hours. The test animals were observed 14 days after exposure of the test substance, afterwards they were sacrificed, and the necropsy for macroscopic examination of the organs was performed. The test item did not cause mortality. Clinical signs or macroscopic changes were not observed.
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. No mortality occurred at the limit dose of 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 fifteenth time in Regulation (EC) No. 2020/1182.
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