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EC number: 287-820-4 | CAS number: 85586-18-1
- 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:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in accordance with international guidelines and in accordance with GLP. All relevant validity criteria were fulfilled.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Monitoring authority
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines
- EC Number:
- 287-820-4
- EC Name:
- Fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines
- Cas Number:
- 85586-18-1
- Molecular formula:
- Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)
- IUPAC Name:
- (Z,9Z)-N-(2-{2-[(8Z)-heptadec-8-en-1-yl]-4,5-dihydro-1H-imidazol-1-yl}ethyl)octadec-9-enimidic acid; 3-[(2-carboxyethyl)({2-[3-(2-carboxyethyl)-2-[(8Z)-heptadec-8-en-1-yl]imidazolidin-1-yl]ethyl})amino]propanoic acid; 3-{2-[(8Z)-heptadec-8-en-1-yl]-3-{2-[(E)-[(9Z)-1-hydroxyoctadec-9-en-1-ylidene]amino]ethyl}imidazolidin-1-yl}propanoic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Three male and three female Sprague-Dawley CD strain rats were supplied by Charles River Lyd, Margate, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non-pregnant. After an acclimatisation period of at least five days, the animals were selected at random and given a number unique within the cage by indelible ink marking on the tail. At the start of the study the animals weighed at least 200g, and were eight to twelve weeks of age.
The animals were housed in suspended solid floor polypropylene cages furnished with woodflakes. The animals were gang housed by sex during the exposure period and and for the remainder of the study. With the exception of an overnight fast immediately bbefore dosing and for apprxomately three to four hours afterward, free access to mains water and food was allowed thoughout the study. Food, water and bedding are routinely anlaysed by the laboratory and were considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
The temperature and humidity were set to within limits of 19 to 25 degrees centigrade and 30 to 70 percent relative humidity respectively. The rate of air exchange was at least fifteeen changes per hour. Lighting was controlled to a twelve hour light ; dark cycle.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each sex to confimr the survival of the previously dosed anima
- Doses:
- 2000 mg/kg (limit test) administered at a dose volume of 1.91 ml/kg undiluted.
- No. of animals per sex per dose:
- Three
- Control animals:
- no
- Details on study design:
- The animals were observed for deaths or overt signs of toxicity, 30 minutes, 1 hour, 2 hours and 4 hours after dosing and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to dosing and at days 7 and 14.
At the end of the study period, all animals were killed by cervical dislocation. All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the thoraic and abdominal cavities for examination of major organs. The appearance of macroscopic abnormalities was recorded . No tissues were retained. - Statistics:
- None
Results and discussion
- Preliminary study:
- The median LD50 was estimated to be > 2,500 mg.Kg bodyweight
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths recorded in the study.
- Clinical signs:
- other: There were no signs of systemic toxicity recorded in the study.
- Gross pathology:
- No abnormalitites were noted at necropsy.
- Other findings:
- None
Any other information on results incl. tables
Mortality data
Sex | # animals | 1/2 hr | 1 hr | 2hr | 4hr | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 11 | Day 12 | Day 13 | Day 14 |
Male | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Female | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Individual clinical observations
Dose | Animal & Sex | # animals | 1/2 hr | 1 hr | 2hr | 4hr | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 11 | Day 12 | Day 13 | Day 14 |
2000 | 1-0 Female |
1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2000 | 1-1 Female |
1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2000 | 1-2 Female |
1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2000 | 2-0 Male |
1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2000 | 2-1 Male |
1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2000 | 2-2 Male |
1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
0 = No signs of systemic toxicity
Individual Bodyweights and weekly bodyweight changes
Dose | Animal & Sex | BW gm Day 0 |
BW gm Day 7 |
BW gm Day 14 |
BW Change in Gm Week 1 |
BW Change in Gm Week 2 |
2000 | 1-0 Female |
218 | 250 | 273 | 32 | 23 |
2000 | 1-1 Female |
209 | 236 | 255 | 27 | 19 |
2000 | 1-2 Female |
208 | 239 | 255 | 31 | 16 |
2000 | 2-0 Male |
209 | 282 | 332 | 73 | 50 |
2000 | 2-1 Male |
216 | 298 | 352 | 82 | 54 |
2000 | 2-2 Male |
212 | 283 | 330 | 71 | 47 |
Where BW = Bodyweight
Individual necropsy findings
Dose | Animal & Sex | Time of death | Macroscopic observations |
2000 | 1-0 Female |
Killed day 14 | No abnormalities noted |
2000 | 1-1 Female |
Killed day 14 | No abnormalities noted |
2000 | 1-2 Female |
Killed day 14 | No abnormalities noted |
2000 | 2-0 Male |
Killed day 14 | No abnormalities noted |
2000 | 2-1 Male |
Killed day 14 | No abnormalities noted |
2000 | 2-2 Male |
Killed day 14 | No abnormalities noted |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material PR-4758 in the Sprague-Dawley CD Strain rat was estimated to be greater than 2,500 mg/kg bodyweight.
- Executive summary:
An Acute oral limit test (project # 1376/003) was commissioned by Nalco Exxon Ltd, UK and performed by Safepharm Laboratories Ltd, UK in accordance with Method B1 Tris of commission directive 96/54/EC. The study was performed in the Sprague Dawley CD rat on PR-4758 grade. The study was performed in strict accordance with GLP. Standard protocols for animal husbandry and test method were followed and no deviations from the husbandry conditions or method recorded. Results indicate that the Acute dermal LD50 in the Sprague Dawley CD rat is > 2,500 mg/kg body weight. No deaths were recorded, there were no clinical signs of systemic toxicity, Bodyweight gain was within normal parameters and no gross abnormalities noted at necropsy.
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