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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
Endpoint summary
Administrative data
Description of key information
IPEMA does not fulfill the criteria for classification as acute toxic for the oral pathway under CLP
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:
- 2020-06-09 to 2020-06-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan (Hino Breeding Center)
- Age at study initiation: 8 weeks
- Weight at study initiation: 188.8 - 205.5 g
- Fasting period before study: 17 to 18 hours before administration, and for three to four hours after administration
- Housing: animals were kept in hanging stainless steel cages with mesh-floor (165Wx300Dx150H mm)
- Historical data: yes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25°C
- Humidity (%): 40-70%
- Air changes (per hr): 10 -12 per hour
- Photoperiod (hrs dark / hrs light): 12h/12h
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% (w/v)
- Justification for choice of vehicle: test substances dissolved in olive oil at a concentration of 20%.
The condition of the formulation such as color did not change at RT for hours after the preparation
- Lot/batch no. (if required): 191224
- Purity: 99.5%
MAXIMUM DOSE VOLUME APPLIED:
Dose level 2000 mg/kg
Dosing volume 10mL/kg - Doses:
- 1. step: animal 1-3: dose 2000 mg/kg
2. step: animal 4-6: dose 2000 mg/kg - No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Clinical signs including body weight : the animals were observed continously for 10 minutes after the administration, and observed 30 minutes and three hours after the administration on the administration day. The animals were observed once int he morning from 1 to 14 days after the administration. Body weights were measured 0 (before administration, 1, 7 and 14 days after the adminsitration. Body weight changes were calculated. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- in the 1st or 2nd step at 2000 mg/kg no mortality nor moribundity occurred. No abnormalities were observed in the animals
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- In the 1st step at 2000 mg/kg, no abnormalities were observed in any animal. In the 2nd step at 2000 mg/kg a decrease (-0.8g) from the previous weight was noted in one animal out of the three 14 days after the administration. The decrease of the body weight was considered as physiological fluctuation since no abnormalities were observed in the general clinical observation, body weights of the other days or gross necropsy and since a body weight decrease is generally observed in females which are eight weeks old and more.
- Gross pathology:
- no abnormalities were observed in any animals
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- or unclassified
- Conclusions:
- IPEMA does not fulfill the criteria for CLP classification as acute toxic for the oral pathway under CLP. LD50 >2000 mg/kg
Reference
Body weights
Step |
Dose (mg/kg) |
Animal No. |
Body weights (g) |
|||
Day after administration |
||||||
Initial |
1 |
7 |
14 |
|||
1st |
2000 |
1 |
194.0 |
208.6 (14.6) |
240.6 (32.0) |
263.5 (22.9) |
2 |
192.2 |
200.7 (8.5) |
228.8 (28.1) |
238.0 (9.2) |
||
3 |
188.8 |
198.7 (9.9) |
231.6 (32.9) |
244.6 (13.0) |
||
2nd |
4 |
194.7 |
210.4 (15.7) |
239.9 (29.2) |
274.8 (34.9) |
|
5 |
190.9 |
207.8 (16.9) |
235.3 (27.5) |
239.1 (3.8) |
||
6 |
205.5 |
221.4 (15.9) |
230.8 (9.4) |
230.0 (-0.8) |
Figures in parentheses indicate differences from previous body weight.
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
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
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.
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