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Diss Factsheets
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EC number: - | CAS number: -
- 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
- Study period:
- 10 March 2009 and 02 April 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Recently conducted GLP compliant study using the most recent test methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): JKY-214
- Physical state: white solid
- Analytical purity: No information
- Lot/batch No.: Y002E
- Expiration date of the lot/batch: No information
- Stability under test conditions: No information. Assumed stable due to no data to the contrary
- Storage condition of test material: room temperature in the dark
- Other:
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 166-182 g
- Fasting period before study: overnight prior to dosing and 3-4 hours post dosing
- Housing: Group housing up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): free access to rodent diet
- Water (e.g. ad libitum): free access to mains water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25oC
- Humidity (%): 30-70%
- Air changes (per hr): at least 15 changes / hr
- Photoperiod (hrs dark / hrs light): 12 hrs light/ 12 hrs dark
IN-LIFE DATES: 14 days, dates not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 300 mg/kg (preliminary); 2000mg/kg (main study)
- Amount of vehicle (if gavage): not reported
- Justification for choice of vehicle: Substance not soluble in water
- Lot/batch no. (if required): not reported
MAXIMUM DOSE VOLUME APPLIED: 2000mg/kg
DOSAGE PREPARATION (if unusual): suspension in vehicle
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: N/A - Doses:
- 300mg/kg preliminary
2000mg/kg main study - No. of animals per sex per dose:
- 300mg/kg: 1 female
2000mg/kg: 5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations were made V2, 1, 2, and 4 hours after dosing and then daily for fourteen days. Morbidity and mortality checks were made twice daily.
Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Not performed
Results and discussion
- Preliminary study:
- 5.1 Dose Level - 300 mg/kg
Individual clinical observations and mortality data are given in table
Dose Level mg/kg Animal Number and Sex Effects Noted After Dosing (Hours)
Effects Noted During Period After Dosing
(Days)
1/2 1 2 4 1 2 3 4 5 6 7 8 9 10 11 12 13 14
300 1-0 Female 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There was no mortality.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the observation period.
- Gross pathology:
- No abnormalities were noted at necropsy
- Other findings:
- none
Any other information on results incl. tables
Individual Clinical Observations and Mortality Data - 2000 mg/kg |
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing (Hours) |
Effects Noted During Period After Dosing (Days) |
||||||||||||||||
1/2 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
2-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-1 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-2 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-3 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Individual Bodyweights and Bodyweight Changes - 2000 mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
Bodyweight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
2-0 Female |
176 |
206 |
215 |
30 |
9 |
3-0 Female |
166 |
167 |
181 |
1 |
14 |
|
3-1 Female |
178 |
192 |
201 |
14 |
9 |
|
3-2 Female |
174 |
200 |
212 |
26 |
12 |
|
3-3 Female |
182 |
197 |
205 |
15 |
8 |
Individual Necropsy Findings - 2000 mg/kg |
Dose Level mg/kg |
Animal Number and Sex |
Time of Death |
Macroscopic Observations |
|
2-0 Female |
Killed Day 14 |
No abnormalities detected |
|
3-0 Female |
Killed Day 14 |
No abnormalities detected |
2000 |
3-1 Female |
Killed Day 14 |
No abnormalities detected |
|
3-2 Female |
Killed Day 14 |
No abnormalities detected |
|
3-3 Female |
Killed Day 14 |
No abnormalities detected |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not acutely toxic by oral exposure
- Executive summary:
The acute oral toxicity has been assessed by means of fixed dose procedure according to EU method B1bis in compliance with GLP. As no mortality or clinical signs were observed at the highest test concentration required by the test guideline and bodyweight gain was as expected for all aninmals the substance is considered not acute toxic by oral administration.
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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