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EC number: 202-268-6 | CAS number: 93-69-6
- 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
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:
- weight of evidence
- Study period:
- Single dose
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Performed to acute toxic class method, but only with males
Some mortality at the single dose tested. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- - Source: Charles River (UK) Ltd, Margate, Kent
- Age at study initiation: five to eight weeks old
- Weight at study initiation: At the start of the main study the males weighed 143 to 172g, and the females 131 to 149g
- Fasting period before study:
- Housing: Solid-floor polypropylene cages furnished with woodflakes.
- Diet: Rat & Mouse Expanded Diet no. 1, Special Diets Services Limites, witham, Essex, UK
- Water: Free access to mains drinking water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 24
- Humidity (%): 46 - 63
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness. - Route of administration:
- oral: gavage
- Doses:
- - dosed once by gavage using a metal cannula attached to a graduated syringe
- No. of animals per sex per dose:
- 5 fasted male were given a single dose
- Dose descriptor:
- LD50
- Effect level:
- 2 390 mg/kg bw
- Mortality:
- Deaths were noted one or two days after dosing
- Clinical signs:
- other: Ataxia, hunched posture and increased salivation with additonal signs or incidents of lethargy, ptosis, decreased respiratory rate, laboured respiration, red/brown stains around the eyes, mouth or snout and toptoe gait. Surviving animals recovered four t
- Other findings:
- Necropsy: Common abnormalities noted at necropsy of animals that died during the study were haemorrhage or pallor of the gastric mucosa. Slight haemorrhage of the large and/or small intestines was also noted at necropsy of animals treated with 2000 mg/kg that died during the study. Additonal abnormalities noted at necropsy of one male treated with 2000 mg/kg that died during the study were haemorrhage of the non-glandular epithelium of the stomach and slight haemorrhage of the bladder. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) and 95% confidence limits of the test material, CASAMINE OTB, in the Sprague-Dawley CD strain rat were calculated by a probit method of Finney D J to be:
Males only: 2390 (1446 - 3950 mg/kg/bodyweight)
No symbol and risk phrase required.
Test material was given evaluation number 1 according to the German Water Hazard Classification Scheme.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 390 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- a)Compound and formulation
TK 11786 was suspended with carboxymethyl-cellulose 2 %. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
b)Animals
Healthy random bred rats of the Tif RAIf (SPF) strain raised on our premises were used for these experiments. They were kept at a room temperature of 22 + 1° C, at a relative humidity of 55 + 5 % and on a 14 hours light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted to our laboratories for a minimum of 4 days and the initial body weight ranged from 180 to 200 grams.
c) Treatment* and observations
During the treatment and observation period the rats were housed individually in Macrolon cages (type 2). Approximately 2 4 hours before treatment an area on the back of the rats of approximately 60 square cm was shaved with an electric clipper, For treatment the substance was evenly dispersed on the skin with a syringe and was covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed, the skin was cleaned with lukewarm water and the reaction of the skin was appraised. - GLP compliance:
- not specified
- 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:
- TEST ANIMALS
- Weight at study initiation: 180-200 g
- Housing: housed individually in metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): constant room temperature of 18 +/- 1° C
- Humidity (%): 55 +/- 5 %
- Photoperiod (hrs dark / hrs light): 10 hours dark / 14 hours light - Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 60 cm2
- % coverage: ~25%
- Type of wrap if used: covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the skin was cleaned with lukewarm water
- Time after start of exposure: After 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2150mg/kg .: ~0.4g // 2780mg/kg .: ~0.5g // 3170 mg/kg .: ~0.6g
- Concentration (if solution): 50% - Duration of exposure:
- 24 hours
- Doses:
- single application, 3 concentrations.
2150 mg/kg
2780 mg/kg
3170 mg/kg - No. of animals per sex per dose:
- 3 male, 3 female per dose.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: obs. at 1hr , 24hrs , 48 hrs, 7d and 14d.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 100 mg/kg bw
- Based on:
- test mat.
- Other findings:
- Within 24 hours after treatment the rats in all dosage groups showed dyspnoea, exophthalmus, curved position and ruffled fur. Three to six days after treatment a severe erythema developed into necrosis.
The surviving animals recovered from systemic symptoms within 8 to 13 days. They were submitted to a necropsy whenever they died, survivors on day 14.
No substance related gross organ changes were seen - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 > 3170mg/kg bw .: not classified under CLP
Reference
Dose (mg/kg) | Concentration % of formulation | Number of Animals | Died within | ||||||||||
1 hour | 24 hours | 48 hours | 7 days | 14 days | |||||||||
♂ | ♀ | ♂ | ♀ | ♂ | ♀ | ♂ | ♀ | ♂ | ♀ | ♂ | ♀ | ||
2150 | 50 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2780 | 50 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3170 | 50 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
No higher doses were possible |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 170 mg/kg bw
Additional information
Justification for selection of acute toxicity – inhalation endpoint
nnex VIII, section 8.5.2, of the REACH Regulation states “Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.” The particle size of OTB has been demonstrated to have a median particle size of , which, being relatively large, is likely to make the risk of inhalation relatively unlikely.
Annex VIII, section 8.5.2, of the REACH Regulation states “Testing by the dermal route is appropriate if: (1) inhalation of the substance is unlikely…” As an acute dermal toxicity study has already been completed (giving a result of LD50 > 2500mg/kg), the acute inhalation study is demonstrated to be unnecessary.
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.