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Diss Factsheets
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EC number: 946-420-6 | CAS number: -
- 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
Acute oral toxicity: LD50 (rat, male/female) > 2000 mg/kg bw (OECD TG 401; GLP, RL2)
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:
- 1996-02-28 to 1996-03-27
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted February 24 th, 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- July 31st, 1992
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Remarks:
- BR strain (VAF plus)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4-6 weeks
- Weight at study initiation: approx. 100 g
- Fasting period before study: over night
- Housing:Animals were housed in groups of up to 5, by sex, in grid-bottomed cages suspended over cardboard lined excreta trays
- Diet (e.g. ad libitum): ad libitum, pelleted diet (SQC Rat and Mouse Maintenance Diet No. 1 Expanded, Special Diet Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum, mains drinking water in polypropylene bottles
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-26°C
- Humidity (%): 34-60%
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 100 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In a preliminary study in one female and one male rat a dose of 2000 mg/kg bw was applied. Since no deaths occurred during the preliminary study the test item was similarly administrered to 5 female and 5 male rats. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed 30 min, 1h, 2h and 4h after dosing. Examinations were conducted daily thereafter. Bodyweight was recorded at the day of dosing and at day 1, 2, 3, 4, 8 and 15.
- Necropsy of survivors performed: yes
- Preliminary study:
- One female and one male rats were administered with 2000 mg/kg bw of the test item.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- not observed
- Clinical signs:
- other: not observed
- Gross pathology:
- no abnormalties observed at necropsy
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item was > 2000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study according to OECD Guideline 401 (1987) and EU method B.1 (1992), groups of fasted, 4-6 weeks old, Sprague Dawley rats (5 female/5 male) were given a single oral dose ofpolyglycerin caprinatein water at a dose of 2000 mg/kg bw and observed for 14 days.
Oral LD50 Males < 2000 mg/kg bw
Females < 2000 mg/kg bw
Combined < 2000 mg/kg bw
no mortality occurred at the applied dose /limit test
Polyglycerin caprinateis of low toxicity based on the LD50 in both sexes (not classified according to GHS criteria).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
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
Acute oral toxicity
In an acute oral toxicity study according to OECD Guideline 401 (1987) and EU method B.1 (1992), groups of fasted, 4-6 weeks old, Sprague Dawley rats (5 female/5 male) were given a single oral dose of polyglycerin caprinate in water at a dose of 2000 mg/kg bw and observed for 14 days.
No mortality occurred at the applied dose. The oral LD50 was >2000 mg/kg bw in male and female rats.
Acute inhalation toxicity
Results of laboratory animal studies show a low acute toxicity after oral exposure. Therefore the acute intrinsic toxic activity of polyglycerin caprylate/caprinate is considered to be low. The occurrence of a systemic toxicity relevant to humans after inhalation is unlikely and therefore the conduct of an acute inhalation toxicity study is unjustified.
Acute dermal toxicity
The testing of acute dermal toxicity of polyglycerin caprylate/caprinate is scientifically not justified. According to the COMMISSION REGULATION (EU) 2016/863 of 31 May 2016 amending Annexes VII and VIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards skin corrosion/irritation, serious eye damage/eye irritation, skin sensitisation and acute toxicity, recent “scientific analysis of available data from in vivo acute toxicity studies have shown that substances that are not toxic via the oral route may be expected with high certainty to be also non-toxic via the dermal route. Therefore, testing those substances via the dermal route does not provide essential information for their safety assessment.” The oral LD50 was determined to be > 2000 mg/kg bw. Thus, no toxicity via the dermal route is to be expected.
There are no data gaps in acute toxicity. Even though there is no information on acute toxicity in humans, there is no reason to believe that the low acute toxicity observed in experimental animals would not be relevant for human health.
Justification for classification or non-classification
Based on the available data, polyglycerin caprylate/caprinate does not need to be classified for acute toxicity according to regulation (EC) 1272/2008. Thus, no labelling is required.
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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