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EC number: 500-334-1 | CAS number: 154565-28-3
- 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
A modern, GLP- and guideline (OECD 425) compliant study of acute oral toxicity is available for the submission substance. Waivers are proposed for acute dermal toxicity (based on the very low acute oral toxicity) and for acute inhalation toxicity (based on the lack of exposure potential).
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:
- 24th March - 1st June 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- Epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol
Batch #CVR 83297
97.2% purity
Supplied by : PPG
Date Received : 23 Mar 2017
Storage : Room temperature and humidity
Description : Clear yellow viscous semi-solid
Specific Gravity : 1.21 - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Females: nulliparous and non-pregnant: yes
- Weight at study initiation: 186-223 g
- Housing: Individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported (temperature controlled)
- Humidity (%): not reproted
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 28/03/2017 To: 26/04/2017 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test material was used as received and the dose was based on the sample weight as calculated from the specific gravity.
- Doses:
- Single gavage dose; 2000 mg/kg bw
- No. of animals per sex per dose:
- Initially, a single female Sprague Dawley rat was dosed orally at a dose level of 2000 mg/kg bw. Since the rat survived, four additional females were dosed at 2000 mg/kg bw.
- Control animals:
- no
- Details on study design:
- Rats were observed at 15 minutes, 1, 2 and 4 hours post-dosing and once daily thereafter for 14 days for toxicity and pharmacological effects. Observations included, but were not limited to: evaluation of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects such as salivation, central nervous system effects including tremors and convulsions, changes in the level of activity, gait and posture, reactivity to handling or sensory stimuli, altered strength, and stereotypies or bizarre behaviour (e.g., self-mutilation, walking backwards). All rats were observed twice daily for mortality on Days 1-14. Body weights were recorded pre-test, weekly, and at termination.
All rats were humanely euthanised using CO2 following study termination and subjected to gross necropsy - Statistics:
- Not required
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All five female rats survived following a single 2000 mg/kg bw oral dose.
- Clinical signs:
- Localised hair loss was observed in one rat on Days 10-14, and wetness of the anogenital area was observed in one rat at 15 minutes post-dosing.
- Body weight:
- All five rats gained body weight by study termination.
- Gross pathology:
- Gross necropsy revealed localised hair loss in one rat.
- Other findings:
- No additional findings were noted
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- No mortality occurred at a dose level of 2000 mg/kg bw. The test material [epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol] does not therefore require classification for acute oral toxicity according to the CLP Regulation.
- Executive summary:
The acute oral toxicity of epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol was investigated in a study using the Up and Down procedure (OECD 425). Rats received a single gavage dose of the unchanged test material and were observed for 14 days. Rats were observed at 15 minutes, 1, 2 and 4 hours post-dosing and once daily thereafter for 14 days for toxicity and pharmacological effects. Bodyweights were recorded weekly. All rats were subject to gross necropsy. Initially, a single female Sprague Dawley rat was dosed orally at a dose level of 2000 mg/kg bw. Since this rat survived, four additional female rats were dosed at 2000 mg/kg bw. No deaths occurred in this group. Localised hair loss was observed in one rat on Days 10-14, and wetness of the anogenital area was observed in one rat at 15 minutes post-dosing. All five rats gained bodyweight by study termination. Gross necropsy revealed localised hair loss in one rat. No mortality occurred at a dose level of 2000 mg/kg bw. The acute oral LD50 is therefore >2000 mg/kg bw. The test material [epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol] does not therefore require classification for acute oral toxicity according to the CLP Regulation.
Reference
Summary of findings
Rats dosed (2000 mg/kg bw) |
Mortality |
Clinical signs |
5 females |
0/5 |
1/5 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- A modern, GLP- and guideline (OECD 425) compliant study of acute oral toxicity is available for the submission substance.
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
The acute oral toxicity of epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol was investigated in a study using the Up and Down procedure (OECD 425). Rats received a single gavage dose of the unchanged test material and were observed for 14 days. Rats were observed at 15 minutes, 1, 2 and 4 hours post-dosing and once daily thereafter for 14 days for toxicity and pharmacological effects. Bodyweights were recorded weekly. All rats were subject to gross necropsy. Initially, a single female Sprague Dawley rat was dosed orally at a dose level of 2000 mg/kg bw. Since this rat survived, four additional female rats were dosed at 2000 mg/kg bw. No deaths occurred in this group. Localised hair loss was observed in one rat on Days 10-14, and wetness of the anogenital area was observed in one rat at 15 minutes post-dosing. All five rats gained bodyweight by study termination. Gross necropsy revealed localised hair loss in one rat. No mortality occurred at a dose level of 2000 mg/kg bw. The acute oral LD50 of epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol is therefore >2000 mg/kg bw.
Justification for classification or non-classification
Based on an acute oral LD50 of >2000 mg/kg bw, the submission substance [epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol] does not require classification for acute oral toxicity according to the CLP Regulation.
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