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EC number: 261-521-9 | CAS number: 58958-60-4
- 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 (OECD 401): LD50 > 5000 mg/kg bw
Inhalation (OECD 436): LC50 > 5.3 mg/L (read-across)
Dermal (OECD 402): LD50 > 2000 mg/kg bw (read-across)
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:
- 3 - 9 Mar 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. The observation period was 6 days, few details were reported, the administration volume was unusually high, the analytical purity was not stated.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted Feb 1987
- Deviations:
- yes
- Remarks:
- observation period 6 days, few details reported, the administration volume was unusually high, analytical purity not reported
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- mouse
- Strain:
- other: NMRI EOPS
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation:20 - 21 g (range) - Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 40 mL/kg bw
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 6 days
- Frequency of observations and weighing: observations of mortality and signs of toxicity were made 3 h after administration and daily thereafter; animals were weighed prior to dosing and prior to necropsy.
- Necropsy of survivors performed: yes - Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality during the study period.
- Clinical signs:
- other: From 30 minutes until 1 hour after administration an unspecified number of the mice had closed eyes, were lethargic and had irregular breathing. No clinical signs of toxicity were observed during the rest of the 6-day observation period.
- Gross pathology:
- No substance-related findings were noted during the necropsy.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The avaialble information comprises an adequate and reliable (Klimisch score 2) study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.3 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: Source: CAS 10233-13-3
- Clinical signs:
- other:
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- Based on the results of the available acute inhalation toxicity study with the source substance CAS 10233-13-3, a LC50 value > 5.3 mg/L (air) was determined. Applying the read-across approach, similar results are expected for the target substance CAS 58958-60-4.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable (Klimisch score 1) study from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, ecotoxicological and toxicological profile (refer to the endpoint discussion for further details).
The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Source: CAS 163961-32-8
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- Based on the results of the available acute dermal toxicity study with the source substance CAS 163961-32-8, a LD50 value > 2000 mg/kg bw was determined. Applying the read-across approach, similar results are expected for the target substance CAS 58958-60-4.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable (Klimisch score 2) study from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, ecotoxicological and toxicological profile (refer to the endpoint discussion for further details).
The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Additional information
Justification for read-across
Data on the acute inhalation and dermal toxicity of Isooctadecyl pivalate (CAS 58958-60-4) are not available. The assessment of acute inhalation and dermal toxicity was therefore based on studies conducted with analogue (source) substances as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
Acute oral toxicity
CAS 58958-60-4
The acute oral toxicity of Isooctadecyl pivalate was assessed in a study that was performed according a protocol similar to OECD guideline 401 and under GLP conditions (Evic-Ceba, 1993). 5 male NMRI EOPS mice were administered 5000 mg/kg bw test substance via the oral route. There was no mortality during the 6-day study period. From 30 minutes until 1 hour after administration an unspecified number of the mice had closed eyes, were lethargic and had irregular breathing, which was probably caused by the applied unusually high dose volume (4 mL/100 g) No other clinical signs of toxicity were observed during the rest of the 6-day observation period. The body weight gain was within the range that is normal for this strain and study type. No findings were reported during the macroscopic examination. The acute oral LD50 value is considered to be > 5000 mg/kg/bw.
Acute inhalation toxicity
CAS 10233-13-3
An acute inhalation study was performed with Isopropyl laurate according to OECD guideline 436 and under GLP conditions (acute toxic class method) (Notox, 2010). 3 male and 3 female Crl:WI(Han) rats were exposed to an analytical concentration of 5.3 ± 0.3 mg/L of the test substance for 4 hours, nose-only. An aerosol was generated by nebulization of the test substance using a nebulizer. There was no mortality during the exposure or within the 14-day observation period. Hunched posture was observed in all animals 1 and 3 hours after exposure. The body weight gain was within the range expected for rats of this strain and age. No abnormalities were found during the macroscopic post-mortem examination of the animals. The inhalatory 4-h LC50 value of Isopropyl laurate in Wistar rats was found to exceed 5.3 mg/L.
Acute dermal toxicity
CAS 163961-32-8
An acute dermal toxicity (limit test) was performed with Fatty acids, C16-18 and C18-unsatd., branched and linear, Bu esters according to OECD guideline 402 and under GLP conditions (Safepharm, 2004). 2000 mg/kg bw of the undiluted test substance was applied to the shaved skin of 5 rats/sex for 24 h under semiocclusive conditions. After the exposure period, residual test substance was removed and the animals were observed for a period of 14 days. No mortality occurred. Male and female rats showed the expected gain in body weight throughout the study, with the exception of 1/5 females that had a boy weight loss the first week and then a body weight gain the second week. The necropsy and histopathological examination did not reveal any substance-related findings. Based on these results, the dermal LD50 value for male and female rats is > 2000 mg/kg bw.
Overall conclusion for acute toxicity
The reliable data available for the target and source substances indicate a very low level of acute toxicity following the oral, inhalation and dermal route, as LD50 values were greater than the currently applied limit values and the LC50 value was the maximum attainable value. Therefore, as the available data did not identify any hazard for acute toxicity, Isooctadecyl pivalate is not considered to be hazardous following acute exposure.
Justification for classification or non-classification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Isooctadecyl pivalate, data will be generated from information on reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.
Therefore, based on the target substance information and analogue read-across approach, the available data on acute toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.
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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