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EC number: 619-290-0 | CAS number: 97780-06-8
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
- Principles of method if other than guideline:
- The purpose of this study was to determine if the LD50 of the test substance exceeded 5000 mg/kg. If all animals dosed at 5000 mg/kg survive the 15-day test period, the LD50 is assumed to be greater than 5000 mg/kg. In addition, clinical signs of abnormality and gross pathologic changes observed in the dosed animals were used in assessing the toxicity of the test material.
Single oral doses of the test material, as suspensions in Mazola® corn oil, were administered by intragastric intubation to a group of 5 male and 5 female rats at a dose rate of 5000 mg/kg of body weight. Rats were fasted approximately 24 hours prior to dosing, with food being returned to the animals approximately one hour after dosing. Individual dose volumes were calculated using fasted body weights obtained prior to dosing. Observations for mortality were made daily throughout the study. Rats were weighed and observed daily (weekends excluded) for clinical signs of toxicity. At study termination, 3 rats per sex were necropsied. - GLP compliance:
- yes
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- Reference substance 002
- Cas Number:
- 97780-06-8
- Test material form:
- solid
- Details on test material:
- -Purity: 96.8%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD®(SD)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Kingston, New York
- Females (if applicable) nulliparous and non-pregnant: No data are available on females
- Age at study initiation: Approximately 7 weeks old
- Weight at study initiation: Males: 214g Range: [207-219g] and Females: 166g [Range: 157-173g]
- Fasting period before study: 24 hours prior to dosing
- Housing: Rats were housed singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): Purina Certified Rodent Chow® #5002
- Water (e.g. ad libitum): No data are available on source of the water
- Acclimation period: Approximately one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23° ± 2°C
- Humidity (%): 50% ± 10%
- Air changes (per hr): No data are available
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- Mazola®
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 300 mg/mL
- Amount of vehicle (if gavage): Males: 3.6 mL; Females: 2.8 mL
- Justification for choice of vehicle: Not provided
- Lot/batch no. (if required): Not provided
- Purity: Not provided - Doses:
- 5000 mg/kg
- 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 and weighing: daily (weekends excluded)
- Necropsy of survivors performed: yes (3 rats per sex)
- Other examinations performed: clinical signs, body weights - Statistics:
- No
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no deaths at the highest dose tested
- Mortality:
- No deaths were recorded
- Clinical signs:
- other: There were no clinical signs of toxicity observed in any of the rats throughout the study.
- Gross pathology:
- Gross pathological examination of rats killed after a 14-day observation period revealed no specific organ toxicity.
Any other information on results incl. tables
Male rats (All weights are in grams)
Animal # |
Initial weight |
Fasted weight |
Weight on Day 1 |
Weight on Day 4 |
Weight on Day 5 |
Weight on Day 6 |
Weight on Day 7 |
Weight on Day 8 |
Weight on Day 11 |
Weight on Day 12 |
Weight on Day 13 |
Weight on Day 14 |
398420 |
243 |
214 |
244 |
266 |
275 |
279 |
284 |
295 |
319 |
326 |
332 |
337 |
398421 |
240 |
211 |
231 |
258 |
260 |
269 |
276 |
284 |
323 |
318 |
323 |
333 |
398422 |
246 |
218 |
235 |
269 |
277 |
281 |
291 |
300 |
312 |
328 |
333 |
331 |
398423 |
238 |
207 |
229 |
261 |
265 |
268 |
276 |
283 |
308 |
323 |
327 |
327 |
398424 |
248 |
219 |
242 |
270 |
277 |
280 |
283 |
290 |
310 |
318 |
330 |
328 |
Female rats (All weights are in grams)
Animal # |
Initial weight |
Fasted weight |
Weight on Day 1 |
Weight on Day 4 |
Weight on Day 5 |
Weight on Day 6 |
Weight on Day 7 |
Weight on Day 8 |
Weight on Day 11 |
Weight on Day 12 |
Weight on Day 13 |
Weight on Day 14 |
398571 |
185 |
164 |
181 |
200 |
209 |
205 |
207 |
213 |
227 |
228 |
225 |
220 |
398572 |
181 |
157 |
174 |
186 |
186 |
181 |
189 |
191 |
201 |
203 |
202 |
202 |
398573 |
188 |
166 |
188 |
197 |
205 |
206 |
207 |
207 |
218 |
217 |
218 |
215 |
398574 |
188 |
170 |
188 |
203 |
207 |
206 |
204 |
212 |
228 |
225 |
232 |
233 |
398575 |
196 |
173 |
191 |
212 |
205 |
216 |
222 |
226 |
241 |
244 |
240 |
236 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (rats) > 5000 mg/kg
- Executive summary:
The purpose of this study was to determine if the LD50 of the test substance exceeded 5000 mg/kg. If all animals dosed at 5000 mg/kg survive the 15-day test period, the LD50 is assumed to be greater than 5000 mg/kg. In addition, clinical signs of abnormality and gross pathologic changes observed in the dosed animals were used in assessing the toxicity of the test material.
There were no mortalities associated with the dose given. The LD50 for both male and female rats was greater than 5000 mg/kg of body weight, the highest dose tested. Other than sporadic, slight, weight losses (up to 3% of previously measured body weights) there were no clinical signs of toxicity observed in any of the rats throughout the study. Gross pathological examination of rats killed after a 14-day observation period revealed no specific organ toxicity.
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