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EC number: 820-780-3 | CAS number: 62568-82-5
- 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
One acute oral LD50 GLP guideline study (Klimisch 1) is available for the Octenylsuccinic Acid. The estimated acute oral toxicity value for the registered substance was 1030 mg/kg body weight in female Wistar rats with approximate 95% confidence interval of 550 to 1750 mg/kg body weight. As the substance is corrosive to the skin, waivers for acute dermal and inhalation toxicity were utilized and studies were not conducted.
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:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animals:
Species : Rat (Rattus norvegicus)
Strain : Wistar (RCCHan:WIST)
Age/Weight at dosing : 8 to 12 weeks, Weight (g) Minimum: 166.3, Maximum: 202.2
Source : Animal Breeding Facility, Jai Research Foundation
Total Number of Animals Used : Eight females (nulliparous and non-pregnant)
Acclimatisation:
Acclimatisation Period : 6 to 16 days
The rats were received into the experimental procedure room and allowed to acclimatise for a period of 6 to 16 days prior to commencement of dosing.
Husbandry Practices:
Caging : Rats were housed individually in standard polypropylene solid bottom cages which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011). These cages have stainless steel top grills with steam sterilized corn cob bedding material and facilities for pelleted feed and drinking water (polypropylene bottle fitted with sipper tube). Rack units were rotated once in a week.
Water Bottle : Each cage was supplied with a polypropylene water bottle with a stainless steel nozzle.
Enrichment : Rats were provided with a wooden block in each cage.
Room Sanitation : Daily: 1. Rack was cleaned with cloth, 2. Floor of experimental procedure room was swept, 3. All work tops and the floor were mopped with a disinfectant solution.
This study complied with all applicable sections of Committee for the Purpose of Control and Supervision on Experiments on Animals (CPCSEA) guidelines and Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011).
Animal Identification:
Each rat was uniquely numbered on the tail using a tattoo machine. Appropriate labels were attached to the cages indicating the study number, test item code and sex, dose, study code, cage number and animal number.
Feed and Water:
The rats were provided with feed and water, ad libitum (with the exception of overnight fasting and three hours post-dosing). The quality of feed and water is regularly monitored at Jai Research Foundation; copies of the relevant certificates of analysis are kept in the study file. There were no known contaminants in the feed and water at levels that would have interfered with the experimental results obtained.
Environmental Conditions:
Animal Room : BMR 27, Department of Toxicology
Environmental Conditions:
Temperature : 20 to 23 °C
Relative Humidity : 49 to 58%
Air Changes : 17 air changes/hour
Photoperiod : The photoperiod was 12 hours artificial light and 12 hours darkness, light hours being 06:00 h – 18:00 h which was maintained through an automatic timer. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Dose Administration:
The test item was mixed with reverse osmosis water to a concentration of 200 (for rat Nº 1), 17.5 (for rat Nº 2), 55 (for rat Nº 3, 5 and 7) and 175 (for rat Nº 4, 6 and 8) mg/mL and then adjusted according to the body weight to permit a constant dose volume (10 mL/kg body weight). Individual dose volumes were adjusted according to body weight and dose level. All rats were dosed by oral gavage (day 1) using a metal cannula attached to a BD 1 mL disposable syringe which was graduated up to 1 mL. Rats were fasted overnight prior to dosing and until three hours post-dosing. - Doses:
- Initially limit test was conducted with the dose level of 2000 mg/kg body weight in rat N° 1. This rat was found dead on day 2 post dose. Hence, a Main Test was conducted with the starting dose level of 175 mg/kg body weight in rat N° 2 (slope 2). The first rat survived; hence the six additional female Wistar rats received doses of 550 (rat N° 3, 5 and 7) and 1750 (rat N° 4, 6 and 8) mg/kg body weight according to the Up and Down Procedure. Stopping criteria for stop dosing for this test met: 5 reversals in 6 tests.
- No. of animals per sex per dose:
- Eight animals total tested. Initially limit test was conducted with the dose level of 2000 mg/kg body weight in rat N° 1. This rat was found dead on day 2 post dose. Hence, a Main Test was conducted with the starting dose level of 175 mg/kg body weight in rat N° 2 (slope 2). The first rat survived; hence the six additional female Wistar rats received doses of 550 (rat N° 3, 5 and 7) and 1750 (rat N° 4, 6 and 8) mg/kg body weight according to the Up and Down Procedure. Stopping criteria for stop dosing for this test met: 5 reversals in 6 tests.
- Control animals:
- no
- Details on study design:
- Observations:
The rats were observed for signs of toxicity and mortality at ½, 1, 2, 3, 4 and 6 hours postadministration on the day of dosing. Subsequently, the rats were observed twice a day for morbidity and mortality for a period of 14 days following oral dosing. The clinical signs were recorded once a day. Individual body weight was recorded prior to dosing on day 1, and on days 8 and 15.
Necropsy:
At study termination, all surviving rats were humanely euthanised by carbon dioxide asphyxiation. All rats on the study were subject to a gross pathological examination consisting of an external examination and opening of abdominal and thoracic cavities. The stomach of each rat was opened, the
contents rinsed/removed, and the mucosal surface was examined for signs of irritation, erosions, ulcers or any other findings. Gross macroscopic changes, if any, were recorded. - Statistics:
- The LD50 was calculated using the Dixon’s maximum likelihood method using software (AOT 425 StatPgm).
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 030 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 550 - <= 1 750
- Mortality:
- Mortalities:
Rats treated at 175 (1 rat, rat N° 2) and 550 (3 rats, rat N° 3, 5 and 7) mg Octenylsuccinic Acid/kg body weight survived through the 14-day observation period. Rats treated at 2000 (1 rat, rat N° 1) and 1750 (3 rats, rat N° 4, 6 and 8) mg Octenylsuccinic Acid/kg body weight died by day 2 post dosing. - Clinical signs:
- Clinical Observations:
No signs of toxicity were observed in the rats treated with 175 (rat N° 2) and 550 (rat N° 3, 5 and 7) mg/kg body weight. Lethargy was observed in the rats treated with 1750 (rat N° 4, 6 and 8) mg/kg body weight whereas lethargy and piloerection were observed in rat N° 1 treated with 2000 mg/kg
body weight.
All surviving animals were active and healthy during the study. - Body weight:
- Body Weights:
There was a normal increase in the body weight of all the surviving rats during the experimental period - Gross pathology:
- Terminal Studies (Macroscopic Findings)
External:
External examination of the found dead and terminally sacrificed rats did not reveal any abnormality.
Internal:
Internal examination of found dead rats revealed lesions such as congestion of the liver (rat N° 1, 4, 6 and 8) and congestion of the lungs (rat N° 1, 4 and 8), whereas the terminally sacrificed rats did not reveal any lesions. Lesions observed in the found dead rats could be correlated with the test item used in the present study. - Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral estimated LD50 of the Octenylsuccinic Acid was estimated to be 1030 mg/kg body weight (Based on an assumed sigma of 0.5) in female Wistar rats with approximate 95% confidence interval is 550 to 1750 mg/kg body weight.
- Executive summary:
An acute oral toxicity study (Up-and-Down Procedure) was conducted using eight female Wistar rats given a single oral dose of Octenylsuccinic Acid in reverse osmosis water. Initially a limit test was conducted with the dose level of 2000 mg/kg body weight in rat N° 1. This rat was found dead on day 2 post dose. Hence, a Main Test was conducted with the starting dose level of 175 mg/kg body weight in rat N° 2. This rat survived; hence the six additional female Wistar rats received doses of 550 (rat N° 3, 5 and 7) and 1750 (rat N° 4, 6 and 8) mg/kg body weight according to the Up and Down Procedure.
No signs of toxicity were observed in the rats treated with 175 (rat N° 2) and 550 (rat N° 3, 5 and 7) mg/kg body weight. Lethargy was observed in the rats treated with 1750 (rat N° 4, 6 and 8) mg/kg body weight whereas lethargy and piloerection were observed in rat N° 1 treated with 2000 mg/kg body weight. Rat N° 1, 4, 6 and 8 were found dead on day 2.
All surviving rats were active and healthy during the study. All surviving rats gained body weight by the end of the study.
External and internal examination of terminally sacrificed rats did not reveal any lesions of pathological significance. Internal examination of found dead rats revealed congestion of the liver (rat N° 1, 4, 6 and 8) and congestion of the lungs (rat N° 1, 4 and 8). Lesions observed in found dead rats could be correlated with the test item used in the present study.
The acute oral estimated LD50 of the Octenylsuccinic Acid was estimated to be 1030 mg/kg body weight (Based on an assumed sigma of 0.5) in female Wistar rats with approximate 95% confidence interval is 550 to 1750 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 030 mg/kg bw
- Quality of whole database:
- acceptable
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
Justification for classification or non-classification
Acute oral category 4 classification (H302: Harmful if swallowed) has been applied for the registered substance based on acute oral toxicity study results.
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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