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EC number: 800-765-8 | CAS number: 1424149-03-0
- 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
No concern for acute toxicity
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:
- 1991-07-03 to 1991-07-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study; well-performed and well documented
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Mean body weight at start of study: males 182 ± 2g, females 180 ± 4g
Age at the start of the study: males approx. 7 weeks, females approx. 8 weeks. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no effect
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts was investigated for tis acute oral toxicity according to the OECD Gudieline 401. No effect was found at the limit dose of 2000 mg/kg bw. No classification is warranted.
- Executive summary:
Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts was investigated for tis acute oral toxicity according to the OECD Gudieline 401. Five male and five female rats received Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts as a 20% solution in water, the administration volume being 10 ml/kg body weight. No mortality, no clinical signs and no body weight effect was observed. The animals killed at the end of the observation period showed no macroscopically visible changes.
No classification is warranted.
Reference
No mortality, no clinical sign and no body weight was observed.
The animals killed at the end of the observation period showed no macroscopically visible changes.
Table: Body weight development [g] |
|||
|
Day 1 |
Day 8 |
Day 15 |
males (n=5) |
181.8± 1.5 |
241.4± 4.0 |
284.4± 6.7 |
females (n=5) |
180.2± 4.4 |
203.2± 7.5 |
219.8± 7.8 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- sufficiently robust; the low acute oral toxicity is in line with the observed low dermal toxicity and low repeated dose oral toxicity
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- other: Limit Test
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species/strain: healthy rats, WISTAR rats Crl: WI(Han) (full barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: male and female
The female animals were non-pregnant and nulliparous.
Number of animals: 5 male and 5 female
Age at the beginning of the study: males: 11 - 12 weeks old
females: 16 - 17 weeks old
Body weight on the day of administration: males: 273 – 304 g;
females: 208 – 232
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No. 7 of the German Act on Animal Welfare the animals were bred for experimental purposes.
Environmental Conditions:
Full barrier in an air-conditioned room
Temperature: 22 +/- 3 °C
Relative humidity: 55 +/-10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: 10 x / hour
Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1018)
Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 030511)
Certificates of food, water and bedding are filed at BSL BIOSERVICE
Adequate acclimatisation period (at least five days) under laboratory conditions
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Preparation of Animals:
The animals were marked for individual identification by tail painting.
Approximately 24 hours before the test, the fur was removed from the dorsal area of the trunk using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used.
Application:
The test item was applied at a single dose, uniformly over an area which was approximately 10% of the total body surface.
The test item was held in contact with the skin by a dressing throughout a 24-hour period except for 2 animals which had unwrapped themselves overnight. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.
No less than 10% of the body surface was cleared for the application.
Prior to the application a detailed clinical observation was made of all animals. - Duration of exposure:
- 24 hours (except for 2 animals which had unwrapped themselves overnight). At the end of the exposure period the residual test item was removed using tap water.
- Doses:
- 2000mg/kg Body weight
- No. of animals per sex per dose:
- 5/sex (one dose- Limit test)
- Control animals:
- no
- Details on study design:
- Observation Period: All animals were observed for 14 days after dosing.
Primary Skin Irritation:
Signs of erythema and oedema were assessed using the scoring system laid down in OECD Guideline 404 .
Scoring System:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef-redness) to eschar formation preventing grading of erythema 4
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm ) 3
Severe oedema (raised more than 1 mm and extending beyond exposure area) 4
Body Weight Assessment: The animals were weighed on day 1 (prior to the application) and on days 8 and 15.
Clinical Examinations:
A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Pathology: At the end of the observation period the animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally (Narcoren®, Merial; lot no. 212041; expiry date: 04/2014) at the dosage of approximately 8 mL/kg bw.
All animals were subjected to gross necropsy. All gross pathological changes were recorded and in case of findings the tissues were preserved for a possible histopathological evaluation. The preserved tissues of which no histopathological evaluation was made will be discarded 3 months after the release of the final report unless otherwise agreed upon with the sponsor. - Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality
- Mortality:
- No Mortality was observed in this study
- Clinical signs:
- other: The nasal discharge was observed on day 1 post-dose in male animal number 1.
- Gross pathology:
- With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: GHS
- Conclusions:
- Under the conditions of the present study, single dermal application of the test item Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts to rats at a dose of 2000 mg/kg body weight was associated with neither mortality nor signs of toxicity.
No classification is warranted. - Executive summary:
Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts was investigated for its acute dermal toxicity in rats according to the OECD Guideline 402. No effect was found at dose of 2000 mg/kg bw but irritation effect was evident.
No classification is warranted.
Reference
Clinical Signs: no effect for males and females
Skin Irritation -Individual Data-Males
Day after Start of Application |
Animal No. 21 |
Animal No. 22 |
Animal No. 23 |
Animal No. 24 |
Animal No. 25 |
|||||
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
|
day 2 |
3/0 |
* |
3/0 |
* |
3/0 |
* |
2/2 |
*, ** |
3/1 |
* |
day 3 |
2/0 |
* |
2/0 |
* |
2/0 |
* |
2/2 |
* |
2/0 |
* |
day 4 |
2/0 |
* |
2/0 |
* |
2/0 |
* |
2/1 |
* |
2/0 |
* |
day 5 |
2/0 |
* |
2/0 |
* |
1/0 |
* |
2/1 |
* |
2/1 |
* |
day 6 |
1/0 |
* |
1/0 |
* |
1/0 |
* |
2/1 |
* |
2/0 |
* |
day 7 |
1/0 |
* |
1/0 |
* |
1/0 |
nsf |
1/1 |
* |
2/0 |
* |
day 8 |
0/0 |
nsf |
1/0 |
small s |
1/0 |
nsf |
1/0 |
es |
1/0 |
es |
day 9 |
0/0 |
nsf |
0/0 |
es |
0/0 |
nsf |
0/0 |
es |
0/0 |
es |
day 10 |
0/0 |
nsf |
0/0 |
es |
0/0 |
nsf |
0/0 |
es |
0/0 |
es |
day 11 |
0/0 |
nsf |
0/0 |
es |
0/0 |
nsf |
0/0 |
es |
0/0 |
es |
day 12 |
0/0 |
nsf |
0/0 |
es |
0/0 |
nsf |
0/0 |
es |
0/0 |
es |
day 13 |
0/0 |
nsf |
0/0 |
es |
0/0 |
nsf |
0/0 |
es |
0/0 |
es |
day 14 |
0/0 |
nsf |
0/0 |
es |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
es |
day 15 |
0/0 |
nsf |
0/0 |
es |
0/0 |
nsf |
0/0 |
s |
0/0 |
es |
Comments: E = erythema; O = oedema; 1, 2, 3, 4 = scoring system laid down in OECD Guideline 404 es = eschar; s = scratches; nsf = no specific findings * = remains of the test item ** = animal was found unwrapped |
Skin Irritation -Individual Data-Females
Day after Start of Application |
Animal No. 26 |
Animal No. 27 |
Animal No. 28 |
Animal No. 29 |
Animal No. 30 |
|||||
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
|
day 2 |
2/1 |
**, |
3/1 |
* |
2/1 |
* |
3/1 |
* |
1/0 |
*,** |
day 3 |
2/0 |
w (1 mm) |
2/0 |
* |
2/0 |
* |
2/0 |
* |
1/0 |
* |
day 4 |
2/0 |
w (1 mm) |
2/0 |
* |
2/0 |
* |
2/0 |
* |
1/0 |
* |
day 5 |
2/0 |
w (1 mm) |
2/1 |
* |
1/0 |
* |
2/0 |
* |
1/0 |
* |
day 6 |
2/0 |
w (1 mm) |
2/0 |
* |
1/0 |
* |
2/0 |
* |
1/0 |
* |
day 7 |
1/0 |
w (1 mm) |
2/0 |
* |
1/0 |
* |
1/0 |
* |
1/0 |
* |
day 8 |
1/0 |
w (1 mm) |
1/0 |
es |
1/0 |
es |
1/0 |
es |
0/0 |
es |
day 9 |
0/0 |
es |
0/0 |
es |
0/0 |
es |
0/0 |
es |
0/0 |
nsf |
day 10 |
0/0 |
es |
0/0 |
es |
0/0 |
es |
0/0 |
es |
0/0 |
nsf |
day 11 |
0/0 |
es |
0/0 |
es |
0/0 |
es |
0/0 |
es |
0/0 |
nsf |
day 12 |
0/0 |
es |
0/0 |
es |
0/0 |
es |
0/0 |
es |
0/0 |
nsf |
day 13 |
0/0 |
es |
0/0 |
es |
0/0 |
es |
0/0 |
es |
0/0 |
nsf |
day 14 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
es |
0/0 |
nsf |
day 15 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
es |
0/0 |
s |
Comments: E = erythema; O = oedema; 1, 2, 3, 4 = scoring system laid down in OECD Guideline 404 es = eschar; s = scratches; nsf = no specific findings; w = wound * = remains of the test item ** = animal was found unwrapped |
Body Weight Development:
Dose: 2000 mg/kg body weight |
||||
Animal No. / Sex |
g |
g |
g |
% |
21 / male |
273 |
258 |
271 |
-1 |
22 / male |
275 |
265 |
276 |
0 |
23 / male |
300 |
285 |
296 |
-1 |
24 / male |
304 |
295 |
312 |
3 |
25 / male |
289 |
279 |
291 |
1 |
26 / female |
208 |
201 |
203 |
-2 |
27 / female |
232 |
225 |
233 |
0 |
28 / female |
224 |
218 |
227 |
1 |
29 / female |
209 |
204 |
212 |
1 |
30 / female |
217 |
215 |
219 |
1 |
Macroscopic Findings no effect for males and no effect for females
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- sufficiently robust; the low acute dermal toxicity is in line with the observed low oral toxicity and low repeated dose oral toxicity
Additional information
Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts was investigated for its oral and dermal acute toxicity according to the OECD Guideline 401 and 402 respectively. No significant effect was found for limit dose of 2000 mg/kg bw both for oral and dermal routes. Clear irritation effect was observed upon dermal application, possibly also related to transient body weight effect in dermal acute toxicity study.
Justification for selection of acute toxicity – oral endpoint
Guideline study; well-performed and well-documented
Justification for selection of acute toxicity – dermal endpoint
Guideline study; well-performed and well-documented
Justification for classification or non-classification
No significant toxic effect was found at limit dose of 2000 mg/kg bw both for oral and dermal routes.
No classification is warranted.
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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