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EC number: 701-440-2 | 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:
- From July 28 to August 14, 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- yes
- Remarks:
- highest temperature recorded was 26 °C
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Esterification products of acrylic acid with reaction products of 2,2-dimethylpropane-1,3-diol and methyloxirane
- EC Number:
- 701-440-2
- Molecular formula:
- (C3H6O)x (C3H6O)y C11H16O4
- IUPAC Name:
- Esterification products of acrylic acid with reaction products of 2,2-dimethylpropane-1,3-diol and methyloxirane
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan U.K. Ltd, Oxon, England.
- Age at study initiation: Approximately 5-7 weeks
- Weight at study initiation: 122-149 g
- Fasting period before dosing: Overnight
- Fasting period after dosing: 4 h
- Housing: Up to 5 rats/sex in metal cages
- Diet: Standard laboratory rodent diet (Special Diet Services RM1(E) SQC expanded pellet), ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21-26 °C
- Humidity: 39-58 %
- Photoperiod: 12 h dark / 12 h artificial light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- - MAXIMUM DOSE VOLUME APPLIED: 3.147 mL/kg bw in preliminary study and 4.916 mL/kg bw in main study
- DOSAGE PREPARATION: Test substance was administered as supplied (specific gravity 1.017).
- Rationale for the selection of the dosage for main study: Dose was selected based on preliminary study conducted on 1 rat/sex/dose at 3200 mg/kg bw and animals were observed for 7 days. - Doses:
- - Preliminary study: 3200 mg/kg bw
- Main study: 5000 mg/kg bw - No. of animals per sex per dose:
- - Preliminary study: 1
- Main study: 5 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: At least twice daily
Clinical signs: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1; subsequently twice daily for 14 days, with the exception of the day of study termination (Day 15)-morning only.
Bodyweight was recorded on Days 1 (prior to dosing), 8 and 15 for main study.
- Necropsy of survivors performed: Yes, all animals were killed by carbon dioxide asphyxiation at study termination (Day 15). All animals were subjected to a macroscopic examination. - Statistics:
- None
Results and discussion
- Preliminary study:
- - No mortality was observed.
- Clinical signs: Piloerection, hunched posture, pallid extremities, increased salivation, abnormal faeces and ungroomed appearance, seen in both rats.
- Bodyweight gain for both rats was considered satisfactory.
- No macroscopic abnormalities were observed in either animal at the terminal necropsy on Day 8.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed at 5000 mg/kg bw.
- Clinical signs:
- other: - Piloerection was observed in all rats within 4 minutes of dosing. This sign persisted and was accompanied in rats later on Day 1 and/or at later intervals during the study by increased salivation, abnormal faeces and ungroomed appearance, seen in all ra
- Gross pathology:
- - No macroscopic abnormalities were observed at necropsy.
- Other findings:
- None
Any other information on results incl. tables
Table 1: Signs of reaction to treatment
Signs of reaction |
No. of rats in group of 1 * or 5 per sex showing signs |
|||
Dose (mg/kg bw) |
||||
3200* |
5000 |
|||
Male |
Female |
Male |
Female |
|
Piloerection |
1 |
1 |
5 |
5 |
Hunched posture |
1 |
1 |
0 |
0 |
Pallid extremities |
1 |
1 |
0 |
0 |
Increased salivation |
1 |
1 |
5 |
5 |
Abnormal faecesa |
1 |
1 |
5 |
5 |
Ungroomed appearanceb |
1 |
1 |
5 |
5 |
* Preliminary studies comprised one male and one female
a Characterised by soft to liquid faeces
b Characterised by soiled/stained fur around face/muzzle or ano/genital region or wet fur
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 for SR 9003 is greater than 5000 mg/kg bw in rats as no mortality was observed at this dose level.
- Executive summary:
In an acute oral toxicity study (limit test) performed according to OECD Guideline 401 and in compliance with GLP, groups (5/sex) of CD rats of Sprague Dawley origin [Hsd:Sprague-Dawley (CD)] were given a single oral dose of Propoxylated neopentylglycol diacrylate (SR 9003) at 5000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination. A preliminary study was also conducted on 1 rat/sex/dose at 3200 mg/kg bw and animals were observed for 7 days.
In the preliminary study, no mortality was observed. Piloerection, hunched posture, pallid extremities, increased salivation, abnormal faeces and ungroomed appearance seen in both rats. Bodyweight gain for both rats was considered satisfactory. No macroscopic abnormalities were observed in either animal at the terminal necropsy on Day 8. In the main study, no mortality was observed. Piloerection was observed in all rats within 4 minutes of dosing. This sign persisted and was accompanied in rats later on Day 1 and/or at later intervals during the study by increased salivation, abnormal faeces and ungroomed appearance, seen in all rats. There were no other signs of reaction to treatment and recovery was complete in all instances by Day 4. Bodyweight gain was considered satisfactory in all rats throughout the study. No macroscopic abnormalities were observed for animals killed at study termination on Day 15. In this study, the combined oral LD50 of Propoxylated neopentylglycol diacrylate (SR 9003) was considered to be greater than 5000 mg/kg bw.
The oral LD50 for Propoxylated neopentylglycol diacrylate (SR 9003) is greater than 5000 mg/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).
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