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EC number: 800-310-3 | CAS number: 78683-74-6
- 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
Oral:
female rats (Acute toxic class method), LD50: 2500 mg/kg bw (cut-off value)
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:
- 2013-01-29 to 2013-04-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany)
- Test type:
- acute toxic class method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Housing and Feeding 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. 0636)
- 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 in groups / individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 011012)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days) under laboratory conditions - Route of administration:
- oral: gavage
- Vehicle:
- cotton seed oil
- Details on oral exposure:
- The animals were marked for individual identification by tail painting.
Prior to the administration a detailed clinical observation was made of all animals.
Prior to the administration food was withheld from the test animals for 16 to 19 hours (access to water was permitted). Following the period of
fasting the animals were weighed and the test item was administered. Food was provided again approximately 4 hours post dosing.
The test item was administered at a single dose by gavage using a feeding tube.
The test item was administered at a dose volume of 10 mL/kg body weight. - Doses:
- The starting dose was selected to be 2000 mg/kg body weight. Compound-related mortality was recorded for 1 animal of step 1.
Based on these results and according to the acute toxic class method regime, a second step was performed at a dose of 2000 mg/kg body weight. No compound-related mortality was recorded for any animal of step 2. Based on these results and according to the acute toxic class
method regime no further testing was required. - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Observation Period
The surviving animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality.
Weight Assessment
The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
Clinical Examination
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. Particular attention was directed to observations of tremor,
convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Pathology
At the end of the observation period the surviving animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally
(Narcoren®, Merial; lot no.: 224052; expiry date: 05/2015) at a 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. - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of
the results is not regarded as necessary. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 500 mg/kg bw
- Mortality:
- One animal of the first step treated with the test item at a dose of 2000 mg/kg died spontaneously on the second day of the study.
All remaining animals survived until the end of the study. - Clinical signs:
- The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity,
piloerection, half eyelid closure, catalepsis, body weight loss, moving the bedding and kyphosis. All symptoms recovered within up to 9 days
post dose in the surviving animals. - Body weight:
- Throughout the 14-day observation period, the overall weight gain of the surviving animals was within the normal range of variation for this strain.
- Gross pathology:
- At necropsy, no treatment-related macroscopic findings were observed in any animal of any step.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, a single oral application of the test item Pentapropenyl succinic anhydride to rats at a dose of
2000 mg/kg body weight was associated with signs of toxicity and mortality.
The median lethal dose of Pentapropenyl succinic anhydride after a single oral administration to female rats, observed over a period of 14 days is:
LD50 cut-off (rat): 2500 mg/ kg bw - Executive summary:
Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight.
The test item was suspended in the vehicle cottonseed oil at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.
All animals used in the study after their entrance at BSL were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15.
All animals were necropsied and examined macroscopically.
Table: Results per Step
Step
Sex/No.
Dose (mg/kg)
Number of Animals
Number of Intercurrent Deaths
1
female/1-3
2000
3
1
2
female/4-6
2000
3
0
One animal of the first step treated with the test item at a dose of 2000 mg/kg died spontaneously on the second day of the study.
All remaining animals survived until the end of the study.
The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, piloerection,
half eyelid closure, catalepsis, body weight loss, moving the bedding and kyphosis. All symptoms recovered within up to 9 days post dose in the surviving animals.
Throughout the 14-day observation period, the overall weight gain of the surviving animals was within the normal range of variation for this strain.
Macroscopic findings of surviving animals:
At necropsy, no treatment-related macroscopic findings were observed in any animal of any step.
Macroscopic findings of the animal not having survived until the end of the observation period:
At necropsy, no macroscopic findings were observed.
Under the conditions of the present study, a single oral application of the test item Pentapropenyl succinic anhydride to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity and mortality.
The median lethal dose of Pentapropenyl succinic anhydride after a single oral administration to female rats, observed over a period of 14 days is: LD50cut-off (rat): 2500 mg/ kg bw
Reference
Table: Clinical Signs - Individual Data
Animal |
Time of |
Observations |
Step 1 (2000 mg/kg Body Weight) |
||
1 / female 3 / female |
30 min |
no signs of toxicity |
1 h |
moderately reduced spontaneous activity; kyphosis, slight piloerection, half eyelid closure |
|
2 h |
slightly reduced spontaneous activity; kyphosis, slight piloerection, half eyelid closure |
|
3 h, 4 h |
slightly reduced spontaneous activity; |
|
d 2 |
moderately reduced spontaneous activity; |
|
d 3 |
moderately reduced spontaneous activity; catalepsis; moderate piloerection; |
|
d 4, d 5 |
moderately reduced spontaneous activity; catalepsis; moderate piloerection; |
|
d 6 |
slightly reduced spontaneous activity; |
|
d 7 |
slight piloerection |
|
d 8 |
slightly reduced spontaneous activity |
|
d 9 until the end of the observation period |
no signs of toxicity |
Animal |
Time of |
Observations |
Step 1 (2000 mg/kg Body Weight) |
||
2 / female |
30 min |
no signs of toxicity |
1 h |
moderately reduced spontaneous activity; kyphosis, slight piloerection, half eyelid closure |
|
2 h |
slightly reduced spontaneous activity; kyphosis, slight piloerection, half eyelid closure |
|
3 h, 4 h |
slightly reduced spontaneous activity; |
|
d 2 |
moderately reduced spontaneous activity; |
|
Step 2 (2000 mg/kg Body Weight) |
||
4 / female |
30 min |
slightly reduced spontaneous activity; moving the bedding; half eyelid closure |
1 h |
slightly reduced spontaneous activity; moving the bedding; slight piloerection; half eyelid closure |
|
2 h |
slightly reduced spontaneous activity; |
|
3 h,4 h, d 2 – d 4 |
slightly reduced spontaneous activity; |
|
d 5 until the end of the observation period |
no signs of toxicity |
Animal |
Time of |
Observations |
Step 2 (2000 mg/kg Body Weight) |
||
5 / female 6 / female |
30 min |
slightly reduced spontaneous activity; moving the bedding; half eyelid closure |
1 h |
slightly reduced spontaneous activity; moving the bedding; slight piloerection; half eyelid closure |
|
2 h |
slightly reduced spontaneous activity; |
|
3 h,4 h, d 2 |
slightly reduced spontaneous activity; |
|
d 3 |
slightly reduced spontaneous activity; |
|
d 4 |
slightly reduced spontaneous activity; |
|
d 5 until the end of the observation period |
no signs of toxicity |
d = day (day 1 = day of administration); h = hour(s); min = minute(s)
Table: Body Weight Development - Absolute Body Weights in g and Body Weight Gain in %
Animal No. / |
g |
g |
g |
% |
Step 1 (2000 mg/kg Body Weight) |
||||
1 / female |
147 |
158 |
182 |
24 |
2 / female |
147 |
animal found dead on day 2 |
||
3 / female |
145 |
153 |
175 |
21 |
Step 2 (2000 mg/kg Body Weight) |
||||
4 / female |
160 |
187 |
211 |
32 |
5 / female |
146 |
167 |
184 |
26 |
6 / female |
155 |
182 |
200 |
29 |
Table: Findings of Necropsy - Individual Data
Animal No./ |
Organ |
Macroscopic Findings |
Step 1 (2000 mg/kg Body Weight) |
||
1 / female |
- |
nsf |
2 / female |
- |
nsf |
3 / female |
oviduct and cervix |
filled with fluid |
Animal No./ |
Organ |
Macroscopic Findings |
Step 2 (2000 mg/kg Body Weight) |
||
4 / female |
- |
nsf |
5 / female |
- |
nsf |
6 /female |
- |
nsf |
Table: LD50 Cut-Off
Dose |
Number of |
Number of Intercurrent Deaths |
LD50 Cut-Off |
2000 mg/kg bw |
6 |
1 |
2500 mg/kg bw |
bw = body weight
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 500 mg/kg bw
- Quality of whole database:
- reliable and robust
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 toxicity of the test item was assessed in a acute toxic class method according to OECD 423.
Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by single oral gavage administration at a dosage of 2000 mg/kg body weight and observed for 14 days. One animal of the first step treated with the test item died spontaaneously on the second day of the study. All remaining animals survived until the end of the study. No macroscopic findings were observed in all animals. Under the condition of the study, the median lethal dose of the test item after a singel oral administration to female rates, observed over a period of 14 days is: LD50cut-off (rat): 2500 mg/ kg bw.
Justification for classification or non-classification
Based on the available data no classification is warranted according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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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