Registration Dossier
Registration Dossier
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EC number: 204-110-1 | CAS number: 115-83-3
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to microorganisms, other
- Remarks:
- activated sludge, and testing with Pseudomonas putida
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Summary of available data used for the endpoint assessment of the target substance.
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to the Analogue Justification provided in IUCLID section 13.
- Reason / purpose for cross-reference:
- other:
- Reason / purpose for cross-reference:
- other:
- Reason / purpose for cross-reference:
- other:
- Duration:
- 3 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Remarks on result:
- other: source, RA-A, CAS 71010-76-9, Exxon, 2008, respiration inhibition, RL1
- Duration:
- 3 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Remarks on result:
- other: source, RA-A, CAS 71010-76-9, Exxon, 2008, respiration inhibition, RL1
- Duration:
- 16 h
- Dose descriptor:
- other: EL 10
- Effect conc.:
- > 10 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth inhibition
- Remarks on result:
- other: source, RA-A, CAS 19321-40-5, 1997, P. putida, growth inhibition, RL2
- Duration:
- 16 h
- Dose descriptor:
- other: EL50
- Effect conc.:
- > 10 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth inhibition
- Remarks on result:
- other: source, RA-A, CAS 19321-40-5, 1997, P. putida, growth inhibition, RL2
- Duration:
- 16 h
- Dose descriptor:
- other: NOELR
- Effect conc.:
- >= 10 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth inhibition
- Remarks on result:
- other: source, RA-A, CAS 19321-40-5, 1997, P. putida, growth inhibition, RL2
- Duration:
- 16 h
- Dose descriptor:
- other: EL10
- Effect conc.:
- > 10 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth inhibition
- Remarks on result:
- other: source, RA-A, CAS 62125-22-8, 1997, P. putida , growth inhibition, RL2
- Duration:
- 16 h
- Dose descriptor:
- other: EL50
- Effect conc.:
- > 10 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth inhibition
- Remarks on result:
- other: source, RA-A, CAS 62125-22-8, 1997, P. putida , growth inhibition, RL2
- Duration:
- 16 h
- Dose descriptor:
- other: NOELR
- Effect conc.:
- >= 10 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth inhibition
- Remarks on result:
- other: source, RA-A, CAS 62125-22-8, 1997, P. putida , growth inhibition, RL2
Reference
Description of key information
No effects up to the limit of water solubility; read-across.
Key value for chemical safety assessment
Additional information
No study investigating the toxicity of pentaerythritol tetrastearate (CAS 115-83-3) to microorganisms is available. Therefore, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substances decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9), pentaerythritol tetraoleate (CAS 19321-40-5) and 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate) (CAS 62125-22-8) is applied.
Based on the high degree of similarity between the structural and physico-chemical properties of the target and source substances, the source substances are considered as suitable representative for the evaluation of the short-term toxicity of the target substance to aquatic invertebrates. The read-across approach is justified in detail within the analogue justification in IUCLID section 13.
A study investigating the toxicity of decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) to aquatic microorganisms is available. The study was conducted under static conditions according to OECD 209 using non-adapted activated sludge obtained from a domestic sewage treatment plant as inoculum. Test concentrations of 10, 100 and 1000 mg/L were prepared. Test substance was added directly to the test vessels. The test substance did not inhibit the respiration rate of activated sludge microorganisms at any of the concentrations employed in the test. Hence, the 3 h-EC50 was determined to be > 1000 mg/L based on the nominal test concentration. The second study investigated the toxicity of pentaerytritol tetraoleate (CAS 19321-40-5) to aquatic microorganisms. The study was conducted under static conditions according to ISO 10712, using an aqueous suspension of Pseudomonas putida as inoculum. A nominal concentration of 10000 mg/L was tested (prepared as WAF). The test substance did not inhibit the growth of Pseudomonas putida. Hence, the 16 h-EL50 was determined to be > 10000 mg/L based on the nominal test concentration. A further study investigating the toxicity of 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate) (CAS 62125-22-8) is available. This study also was conducted under static conditions according to ISO 10712. An aqueous suspension of Pseudomonas putida was used as inoculum. A nominal concentration of 10000 mg/L was tested(prepared as WAF). The test substance did not inhibit the growth of Pseudomonas putida. Hence, the 16 h EL50 was determined to be > 10000 mg/L based on the nominal test concentration.
Based on the available results from structurally related source substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that pentaerythritol tetrastearate (CAS 115-83-3) will not exhibit effects to microorganisms up to the limit of water solubility.
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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