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EC number: 217-121-1 | CAS number: 1745-89-7
- 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
1)The acute oral toxicity study was performed to assess the acute oral toxicity of the test item in the rat.
2)The acute dermal toxicity study was performed to asses the acute dermal toxicty of the test item, (TK 11907), in the rat.
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:
- Date of acclimatization: 20 November 1985; Date of administration:27 November 1987 and 2 December 1985; Date of Completion: 16 December 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP methodology followed.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Tif: RAIf (SPF), F3-hybrid of RII 1/Tif x RII 2/Tif
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rationale
The rat has been selected for this test as being a Standard species for the determination of an acute oral LD50.
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland.
- Initial Body Weight Range: 171 - 216 g
- Initial Age: 7-8 weeks
- Individual Identification: by colour code using picric acid
- Husbandry: The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Hacrolon cages type 4 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin)
The animal room was air conditioned: temperature 22±3° C, relative humidity 55±15%, 12 hours light/day, approximately 15 air changes/h.
Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum. - Route of administration:
- oral: gavage
- Vehicle:
- other: Ol. Arachidis Ph. H. VI (Siegfried AG, Zofingen/Switzerland)
- Details on oral exposure:
- - Administration of the test article: One single dose, per os
- Volume (ml/kg body weight) applied: 10 - Doses:
- 2000 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females per dose level (in total 20 animals)
- Control animals:
- no
- Details on study design:
- - Pretreatment: Prior to dosing, the animals were fasted overnight.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
*Mortality: daily ; a.m. and p.m. on working days, a.m. on weekend days
*Signs and symptoms: daily
*Body weight: on days 1, 7, 14, and at death
- Necropsy of survivors performed: yes Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period. - Statistics:
- From the body weights, the group means and their Standard deviations were calculated.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 - < 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 5 females died (100%. 1 day 1 and 4 day 2 of post exposure)
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 2 males died (40%: 1 day of post exposure period and day 6 post exposure).LD50 perhaps > 5000 mg/kg w
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 - < 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At 2000 mg/kg bw: No mortality
At 5000 mg/kg bw: 2 males (40%: 1 day of post exposure period and day 6 post exposure)) and 5 females (100%. 1 day 1 and 4 day 2 of post exposure) - Clinical signs:
- other: The surviving animals recovered within 6-12 days
- Gross pathology:
- No deviations from normal morphology were found in the animals of the 2000 mg/kg bw dose group.
Dilatation of the small intestine was observed in one male and one female of the 5000 mg/kg bw dose group. In the same female hemorrhagic lungs were detected. - Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Upon an acute oral administration and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated, where possible) was determined for TK 11907.
LD50 in male rats: > 2000, perhaps > 5000 mg/kg bw.
LD50 in female rats: > 2000, < 5000 mg/kg bw.
LD50 in rats of both sexes: > 2000, < 5000 mg/kg bw.
. - Executive summary:
The study, project no. 851045, was conducted to determine the acute oral toxicity of TK 11907 in albino rats.
All the work was done at the Sisseln facility (CH-4332 Stein/Switzerland).
This experiemnt was performed according to the OECD 401.
Upon the acute oral administration and a 14 day post-treatment observation period, the following LD50 was determined for TK 11907.
LD50 in male rats: > 2000, perhaps > 5000 mg/kg bw.
LD50 in female rats: > 2000, < 5000 mg/kg bw.
LD50 in rats of both sexes: > 2000, < 5000 mg/kg bw.
Symptoms
Dyspnea, ruffled fur, and curved body position were seen, being common symptoms in acute tests.
Additionally, diarrhea was observed in both dose groups on the administration and on day 1 after the administration.
Sedation was observed in the animals of the 5000 mg/kg bw dose group from 2 hours up to day 1 after the administration.
The surviving animals recovered within 6-12 days.
Mortality
At 2000 mg/kg bw: No mortality
At 5000 mg/kg bw: 2 males (40%: 1 day of post exposure period and day 6 post exposure)) and 5 females (100%. 1 day 1 and 4 day 2 of post exposure)
Reference
Signs and symptoms:
Observations | Exposure day: hours | Day of post-exposure period | ||||||||||||||||
Observation | 1 | 2 | 3 | 5 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | >13 |
2000 mg/kg | ||||||||||||||||||
Dyspnea | X | X | X | X | X | X | X | X | ||||||||||
Ruffled fur | X | XX | XX | XX | XX | X | X | X | X | |||||||||
Diarrhea | X | X | ||||||||||||||||
Body positioncurved | X | X | X | X | X | X | ||||||||||||
5000 mg/kg bw | ||||||||||||||||||
Sedation | X | X | X | X | ||||||||||||||
Dyspnea | XX | XX | XX | XX | XX | X | X | X | XX* | XX | XX | X | X | X | ||||
Ruffled fur | X | XX | XX | XX | XX | XX | XX | XX | XX# | XX | X | X | X | X | X | |||
Diarrhea | X | X | ||||||||||||||||
Body position curved | X | X | X | X | X | X | X | X | X | X | X | X |
X=slight XX=moderate XXX=marked
*=only in animal N°1 (male)
#=only in animal N°3 (male)
Body weight and standard deviations:
Males | |||
dose mg/kg | Day 1 | Day 7 | Day 14 |
2000 | 193/7.2 | 258/8.9 | 292/9.3 |
5000 | 205/7.0 | 230/21.7 | 293/27.2 |
Females | |||
Dose mg/kg | Day 1 | Day 7 | Day 14 |
2000 | 176/3.4 | 202/6.2 | 214/5.3 |
5000 | 193/5.3 | / | / |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Date of acclimatization: 27 November 1985; Date of application: 3 December 1985 ; Date of completion: 17 December 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP methodology followed.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Rat, Tif: RAIf(SPF), F3-hybrid of Ril 1/TIF x Ril 2/Tif
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- -RationaIe: The rat has been selected for this test as being a Standard species for the determination of an acute dermal LD50.
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Initial Body Weight Range: 203 - 242 g
- Initial Age: 7-8 weeks
- Tndividual Identification: By cage number
- Husbandry: The animals were kept under conventional laboratory conditions. They were caged individually in Macroion cages type 2 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin).
The animal room was air conditioned: temperature 22±3° C, relative humidity 55±15%, 12 hours light/day, approximately 15 air changes/h.
- Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland),and water were provided ad libitum. - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Liquid substance, used undiluted.
- Details on dermal exposure:
- - Volume (ml/kg body weight) applied: 2
- Pretreatment: Approximately 24 hours before treatment an area on the back of the rat of at least 10% of the body surface was shaved with an
electric clipper.
- Application: The required amount of the test substance was evenly dispersed on the skin. It was covered with a gauze-lined semiocclusive dressing, which was fastened around the trunk with an adhesive elastic bandage.After an exposure period of 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the reaction of the skin was appraised repeatedly.
days - Duration of exposure:
- One single dose, applied onto the skin of the back.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females (in total 10 rats)
- Control animals:
- other:
- Details on study design:
- - Duration of observation period following administration: 14 days
- Mortality: daily, a.m. and p.m. on working days, a.m. on weekends
- Signs and Symptoms: daily
- Body weight: on days 1, 7, and 14
- Necropsies: The animals were submitted to a gross necropsy at the end of the observation period. - Statistics:
- From the body weights, the group means and their Standard deviations were calculated.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: Dyspnea, ruffled fur, and abnormal body positions were seen, being common symptoms in acute tests. Additionally, erythema reactions were observed from day 1 to day 8 after the application and edema reactions from day 4 to day 8 after the application. The
- Other findings:
- Autopsie: No deviations from normal morphology were found.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Upon an acute dermal application and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated where possible) was determined for TK 11907.
- Executive summary:
The study, project no. 851048, was conducted to determine the acute dermal toxicity of TK 11907 in albino rats.
All the work was done at the Sisseln facility (CH-4332 Stein/Switzerland).
This experiemnt was performed according to the OECD 405.
Upon an acute dermal application and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated where possible) was determined for TK 11907.
LD50 in male rats; > 2000 mg/kg bw.
LD50 in female rats: > 2000 mg/kg bw.
LD50 in rats of both sexes: > 2000 mg/kg bw.
Symptoms
Dyspnea, ruffled fur, and abnormal body positions were seen, being common symptoms in acute tests.
Additionally, erythema reactions were observed from day 1 to day 8 after the application and edema reactions from day 4 to day 8 after the application.
The animals recovered within 13 days.
Reference
Signs and symptoms:
Observations | Exposure day: hours | Day of post-exposure period | ||||||||||||||||
Observation | 1 | 2 | 3 | 5 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | >13 |
2000 mg/kg | ||||||||||||||||||
Dyspnea | XX | XX | XX | XX | X | X | X | X | X | X | X | X | X | X | X | X | ||
Ruffled fur | X | X | X | X | X | X | X | X | X | X | X | X | X | |||||
Body position ventral | X | X | X | X | X | |||||||||||||
Body position curved | X | X | X | X | ||||||||||||||
Erythema | X | X | X | X | ||||||||||||||
Edema | X | X | X | X | X |
X=slight XX=moderate XXX=marked
Body weight and standard deviations:
Males | |||
dose mg/kg | Day 1 | Day 7 | Day 14 |
2000 | 211/5.5 | 256/8.5 | 305/12.1 |
Females | |||
Dose mg/kg | Day 1 | Day 7 | Day 14 |
2000 | 216/15.2 | 214/13.4 | 226/9.8 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
1)This study was conducted to determine the acute oral toxicity of TK 11907 in albino rats.
Upon the acute oral administration and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated, where possible) was determined for TK 11907.
LD50 in male rats: > 2000
LD50 in female rats: > 2000, < 5000 mg/kg bw.
LD50 in rats of both sexes: > 2000, < 5000 mg/kg bw.
Symptoms
Dyspnea, ruffled fur, and curved body position were seen, being common symptoms in acute tests.
Additionally, diarrhea was observed in both dose groups on the administration and on day 1 after the administration.
Sedation was observed in the animals of the 5000 mg/kg bw dose group from 2 hours up to day 1 after the administration.
The surviving animals recovered within 6-12 days.
Mortality
At 2000 mg/kg bw: No mortality
At 5000 mg/kg bw: 2 males (40%: 1 day of post exposure period and day 6 post exposure)) and 5 females (100%. 1 day 1 and 4 day 2 of post exposure)
2)The study was conducted to determine the acute dermal toxicity of TK 11907 in albino rats.
Upon an acute dermal application and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated where possible) was determined for TK 11907.
LD50 in male rats; > 2000 mg/kg bw.
LD50 in female rats: > 2000 mg/kg bw.
LD50 in rats of both sexes: > 2000 mg/kg bw.
Symptoms
Dyspnea, ruffled fur, and abnormal body positions were seen, being common symptoms in acute tests.
Additionally, erythema reactions were observed from day 1 to day 8 after the application and edema reactions from day 4 to day 8 after the application.
The animals recovered within 13 days.
Justification for selection of acute toxicity – oral endpoint
Only this study is available
Justification for selection of acute toxicity – inhalation endpoint
In accordance with column 2 of REACH (Regulation (EC) No 1907/2006) Annex VIII, the acute toxicity by inhalation study (required in section 8.5.2) does not need to be conducted as acute toxicity studies are available for the oral and dermal routes of exposure. Furthermore, the substance is marketed in a form which are is not inhalable.
Justification for selection of acute toxicity – dermal endpoint
Only this study is available
Justification for classification or non-classification
Based on the above mentioned results the substance does not need to be classified according to CLP regulation (Regulation EC No.1272/2008) and DSD (Directive 67/548/EEC).
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