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EC number: 807-702-3 | CAS number: 3225-26-1
- 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
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Endpoint summary
Administrative data
Description of key information
The acute oral LD50 toxicity of 4-Hydroxy-TEMPO was tested in a standard OECD 401 guideline study. Classification: H302, Harmful if swallowed. An LD50 of 1053 mg/kg bw was determined. The acute dermal LD50 toxicity of 4-Hydroxy-TEMPO was tested in a standard OECD 402 guideline study. A limit test with rats at 2000 mg/kg bw dose was performed. A LD50 of >2000 mg/kg was determined. Thus, no classification in regard of dermal toxicity is necessary.
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:
- 1983-07-29 to 1983-11-14
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif:RAIf(SPF); F3 crosses of RII1/Tif x RII 2/Tif
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Ltd. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 166 - 226 g
- Fasting period before study: yes, overnight prior to dosing
- Housing: in groups of 5 in Macrolon cages type IV
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ±3°C
- Humidity: 55 ±15%
- Air changes: 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 20. Sept. 1983 To: 06. Oct. 1983 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- (distilled)
- Details on oral exposure:
- VEHICLE
- Purity: distilled water
MAXIMUM DOSE VOLUME APPLIED: 20 mL / kg body weight - Doses:
- 5000 and 2000 mg/kg bw (Sep. 20, 1983)
1000 and 500 mg/kg bw (Sep. 22, 1983) - No. of animals per sex per dose:
- 5 male and 5 female (total: 40 rats)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days or until all symptoms have disappeared, whichever lasts longer
- Frequency of observations: twice daily on workdays (a.m. and p.m.); once daily on weekends (a.m.)
- Frequency of weighing: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, daily - Statistics:
- Body weight: group means & standard deviations
LD50 and the 95% confidence limit: Logit method (J. Berkson, J. Am. Stat. Ass., 39. 357-65, 1944) - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 053 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 834 - 1 375
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 953 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 574 - 1 451
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 155 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 784 - 2 194
- Mortality:
- 500 mg/kg bw: 0 (males); 0 (females)
1000 mg/kg bw: 2 within 2 h and 1 on day 1 (males); 1 within 2 h (females)
2000 mg/kg bw: 3 within 1 h and 2 within 2 h (males); 3 within 1 h, 1 within 2 h and 1 on day 1 (females)
5000 mg/kg bw: 5 within 1h (males); 5 within 1h (females)
Surviving animals recovered within 9 days. - Clinical signs:
- other: Dyspnoea, exophthalmus, ruffled fur and curved body position. In addition: Ventral and lateral body position, tonic-clonic convulsions and sedation (in all dose groups: dyspnea and convulsions, the latter for up to 5h past dose, incl. non-moribund animals
- Gross pathology:
- No findings, some isolated cases of spotted edematous lungs.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral LD50 toxicity of 4-Hydroxy TEMPO was tested in a standard OECD 401 guideline study. An LD50 of 1053 mg/kg bw was determined.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 053 mg/kg bw
- Quality of whole database:
- Study according to guideline
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and guideline conform study
Additional information
Oral:
In an acute oral toxicity study (83-0232 -FGT), rats (5/sex) were given a single oral dose of 4-Hydroxy-TEMPO in distilled water at doses of 0, 500, 1000, 2000 or 5000 mg / kg bw. Animals were then observed for 14 days. The following treatment related clinical signs were noted: Dyspnoea, exophthalmus, ruffled fur and curved body position. In addition: Ventral and lateral body position, tonic-clonic convulsions and sedation (in all dose groups: dyspnoea and convulsions, the latter for up to 5 hrs past dose, incl. non-moribund animals). Oral LD50 combined: 1053 mg/kg bw (males: 953, females 1155 mg/kg bw).The study was QA-monitored (GLP was not compulsory in 1983) and it satisfies the requirements of OECD test guideline 401. The study is considered acceptable (key study).
Justification for selection of acute toxicity – oral endpoint
Adequate assay to address endpoint
Justification for selection of acute toxicity – dermal endpoint
Only one GLP and guideline study available.
Justification for classification or non-classification
Based on the results of the acute oral toxicity study, the test substance should be classified as Xn, R22 (Harmful, Harmful if swallowed) according to the criteria of EU Directive 67/548/EEC and as Cat. 4, H302 (Harmful if swallowed) according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.
Based on the results obtained from acute dermal toxicity study, the substance was not classified and labeled in respect to dermal toxicity according to Regulation (EC) No 1272/2008 (CLP) and Directive 67/548/EEC (DSD).
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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