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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This 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:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Monitoring authority
- Test type:
- fixed dose procedure
- 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
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Five male and five female Wistar (HSdlHAN:WIST) strain rats were supplied by Harlan Laboratories UK Ltd, Oxon, 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 study by indelible ink marking on the tail and a number written on the cage card. At the start of the study the animals weighed at least 200 g, and were eight to twelve weeks of age.
The animals were housed in suspended solid floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24 hour exposure period and gang housed up to four per sex for the remainder of the study. 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 (06:00 am to 18:00 pm) dark cycle.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- On the day before treatment the back and flanks of each animal were clipped free of hair. Initially one male and one female were treated at a dose level of 2,000 mg/kg in the absence of data suggesting any toxicity.
The calculated volume of test material as received was applied evenly to an area of shorn skin (approximately 10% of the total body surface area using a graduated syringe. A piece of surgical gauze was placed over the treatment area and semi occluded with a piece of self-adhesive tape. The animals were caged individually for the 24 hour exposure period . Shortly after dosing the dressings were examined to ensure that they were securely in place.
After the 24 hour contact period, the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove ant residual test material.
As no mortalities were noted a further group of animals (four male and four females) was similiarly treated with the test material at a dose of 2,000 mg/kg body weight to give a total of five male and five females. After the 24-hour contact period the bandages were carefully removed, the skin and surrounding hair cleaned with cotton wool moistened with distilled water. These animals were gang housed for the remainder of the study. - Duration of exposure:
- 24 hour exposure period with fourteen day post exposure period.
- Doses:
- 2,000 mg/kg
- No. of animals per sex per dose:
- Five
- Control animals:
- not required
- Details on study design:
- The animals were observed for death or overt signs of toxicity 30 minutes, one hour, two hours and four hours after dosing and subsequently once daily for fourteen days.
After removal of the dressings and subsequently once daily for fourteen days, the test sites were examined for evidence of primary irritation and scored according to the Draize scale (Draize JH (1977) Dermal and eye toxicity tests). Any other skin reactions if present were also recorded.
Individual body weights were recorded prior to the application of the test material on Day 0, Day 7 and 14.
A the end of the study the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoraic cavities. The appearance of any macroscopic abnormalities was recorded. No tissue samples were retained.
- Statistics:
- None
Results and discussion
- Preliminary study:
- LD50 > 2,000 mgKg
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths in either sex
- Clinical signs:
- other: There were no signs of systemic toxicity in either sex
- Gross pathology:
- Individual examinations were made
No abnormalities were noted - Other findings:
- Individual dermal reactions were measured.
Very slight to well defined erythema was noted at the test sites of four males and four females. Other dermal reactions noted at the test site of one female was haemorrhage of dermal capillaries, small superfical scattered scabs and crust formation. Treated skin sites of one male and one female appeared normal throughout the study. The remaining treated skin sites of all other animals appeared normal 3 to 9 days after dosing.
Any other information on results incl. tables
Individual Clinical observations and mortality data
Dose mg/kg |
Animal & Sex |
1/2hr |
1hr |
2hr |
4hr |
1d |
2d |
3d |
4d |
5d |
6d |
7d |
8d |
9d |
10d |
11d |
12d |
13d |
14d |
||
2000 |
1-0 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
2000 |
3-0 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
2000 |
3-1 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
2000 |
3-2 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
2000 |
3-3 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
2000 |
2-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
2000 |
4-0 Female |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
2000 | 4-1 Female |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
2000 | 4-2 Female |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
2000 | 4-3 Female |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Individual Bodyweights and weekly bodyweight changes
Dose mg/kg |
Animal & Sex |
BW day 0 gm |
BW day 7 gm |
BW day 14 gm |
BW Change gm during week 1 |
BW Change gm during week 2 |
2000 | 1-0 Male | 245 | 263 | 280 | 18 | 17 |
2000 | 3-0 Male | 237 | 254 | 302 | 17 | 48 |
2000 | 3-1 Male | 238 | 269 | 298 | 31 | 29 |
2000 | 3-2 Male | 231 | 252 | 281 | 21 | 29 |
2000 | 3 -3 Male | 231 | 252 | 281 | 21 | 29 |
2000 | 2-0 Female | 211 | 212 | 220 | 1 | 8 |
2000 | 4-0 Female | 216 | 218 | 222 | 2 | 4 |
2000 | 4-1 Female | 216 | 215 | 218 | -1 | 3 |
2000 | 4-2 Female | 219 | 220 | 221 | 1 | 1 |
2000 | 4-3 Female | 203 | 203 | 206 | 0 | 3 |
Where BW = Bodyweight
Individual necropsy findings
Dose Mg/kg |
Animal & Sex |
Time of death | Macroscopic observations |
2000 | 1-0 Male | Killed day 14 | No abnormalities detected |
2000 | 3-0 Male | Killed day 14 | No abnormalities detected |
2000 | 3-1 Male | Killed day 14 | No abnormalities detected |
2000 | 3-2 Male | Killed day 14 | No abnormalities detected |
2000 | 3-3 Male | Killed day 14 | No abnormalities detected |
2000 | 2-0 Female | Killed day 14 | No abnormalities detected |
2000 | 4-0 Female | Killed day 14 | No abnormalities detected |
2000 | 4-1 Female | Killed day 14 | No abnormalities detected |
2000 | 4-2 Female | Killed day 14 | No abnormalities detected |
2000 | 4-3 Female | Killed day 14 | No abnormalities detected |
Individual Dermal reactions
Dose mg/kg |
Animal & Sex |
Observation | D1 | D2 | D3 | D4 | D5 | D6 | D7 | D8 | D9 | D10 | D11 | D12 | D13 | D14 |
2000 | 1-0 Male | Erythema Oedema Other |
0 0 0 |
1 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
2000 | 3-0 Male | Erythema Oedema Other |
0 0 0 |
1 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
2000 | 3-1 Male | Erythema Oedema Other |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
2000 | 3-2 Male | Erythema Oedema Other |
0 0 0 |
1 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
2000 | 3-3 Male | Erythema Oedema Other |
0 0 0 |
1 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
2000 | 2-0 Female | Erythema Oedema Other |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
2000 | 4-0 Female | Erythema Oedema Other |
1 0 0 |
1 0 0 |
1 0 0 |
1 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
2000 | 4-1 Female | Erythema Oedema Other |
2 0 0 |
2 0 0 |
2 0 Hd |
1 0 Hd |
0 0 Hd |
0 0 Hd |
0 0 Ss |
0 0 Cf |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
2000 | 4-2 Female | Erythema Oedema Other |
1 0 0 |
1 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
2000 | 4-3 Female | Erythema Oedema Other |
1 0 0 |
1 0 0 |
1 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
Where 0= No reactions, Hd = haemorrhage of dermal capillaries, Ss = Small superfical scabs, Cf = Crust formation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2,000 mg/kg
- Executive summary:
An Acute dermal limit test (project # 3180/006) was commissioned by Nalco Ltd, UK and performed by Harlan Laboratories Ltd, UK in accorance with Method B4 of commision regulation 440/2008. The study was performed in the Wistar rat on PR-4758 technical grade (batch # FA0A0049). The study was performed in strict accordance with GLP. Standard protocols for animal husbandy and test method were followed and no deviations from the husbandy conditions or method recorded. Results indicate that the Acute dermal LD50 in the Wistar rat is > 2,000 mg/kg. No deaths were recorded, there were no clinical signs of systemic toxicity. Bodyweight gain was within normal parameters, no significant dermal irritation effects were recorded and no gross abnormalities noted at necrospy.
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