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EC number: 248-688-3 | CAS number: 27841-06-1
- 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
Endpoint summary
Administrative data
Description of key information
Short-term repeated dose toxicity: oral (read-across, equivalent/similar to OECD 407): NOAEL >= 1000 mg/kg bw/day
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Remarks on result:
- other: Source: CAS 189120-64-7, Exxon, 2000
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- System:
- urinary
- Organ:
- kidney
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- no
- Conclusions:
- In an oral short-term (28-day) repeated dose toxicity study with an adequate analogue source substance, a NOAEL of >= 1000 mg/kg bw/day was obtained, representing the highest dose tested. As explained in the analogue justification, this result is considered to be valid also for the target substance.
Reference
An increased amount of hyaline droplets in the proximal cortical tubular epithelium was confirmed microscopically in the cytoplasm of the renal cortical tubular epithelial cells in male rats treated with 300 and 1000 mg/kg bw/day, respectively. This phenomenon is widely accepted to be specific to the male rat and as such is considered to have no relevance to man.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The available information comprises an adequate and reliable (Klimisch score 2) study from a source substance with similar structure and intrinsic properties. Read-across is justified based on common precursors and hydrolysis products and consistent trends in environmental fate, ecotoxicological and toxicological profiles. The selected study is thus sufficient to fulfil the standard information requirements set out in Annexes VIII - X, Item 8.6, in accordance with Annex XI, Item 1.5, of Regulation (EC) No. 1907/2006 (REACH).
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No data on the short-term (28-day) repeated dose toxicity for the target substance neopentyl glycol dicaprate (CAS 27841-06-1) are available. Therefore, the repeated dose toxicity endpoint was assessed based on data from the analogue source substance fatty acids, C7-8, triesters with trimethylolpropane (CAS 189120-64-7).
A 28-day oral repeated dose toxicity study with fatty acids, C7-8, triesters with trimethylolpropane (CAS 189120-64-7) was performed according to OECD guideline 407 and under GLP conditions (Exxon, 2000). Groups of five male and five female Cr:CD BR rats were exposed to the substance at 100, 300 and 1000 mg/kg bw/day by gavage, 7 days/week for 28 days. Control animals (five per sex and dose) received the concurrent vehicle, peanut oil. Observations and examinations of the animals included clinical signs, body weight, food consumption, haematology parameters, clinical chemistry parameters, organ weights, neurobehaviour, gross necropsy and histopathology. No mortality was observed during the study period. Female animals tolerated the daily oral administration of the test substance without any toxicologically relevant adverse effects up to the high dose of 1000 mg/kg bw/day. In male animals adverse effects were observed in the histopathology examination. An increased amount of hyaline droplets (the main constituent of which is alpha-2µ-globulin) in the proximal cortical tubular epithelium was confirmed microscopically in the cytoplasm of the renal cortical tubular epithelial cells in male rats treated with 300 and 1000 mg/kg bw/day, respectively. As this phenomenon is widely accepted to be specific to the male rat and as such is considered to have no relevance to man, the 28-day oral NOAEL, for fatty acids, C7-8, triesters with trimethylolpropane was found to be 1000 mg/kg bw/day for male and female rats.
The available data indicate a low level of short-term (28-day) repeated dose toxicity after oral application for the source substance. Therefore, no hazard for oral repeated dose toxicity is expected for the target substance.
Justification for classification or non-classification
The available data on short-term (28-day) oral repeated dose toxicity of the analogue source substance fatty acids, C7-8, triesters with trimethylolpropane (CAS 189120-64-7) do not meet the classification criteria according to the CLP Regulation (EC) No. 1272/2008. Based on read-across, also no classification is warranted for the target substance neopentyl glycol dicaprate (CAS 27841-06-1). Data are, therefore, conclusive but not sufficient for classification.
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