Registration Dossier
Registration Dossier
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EC number: 911-254-5 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- IONOL K78/K72
- Type of composition:
- boundary composition of the substance
- State / form:
- liquid
- Reference substance:
- IONOL K78/K72
- Reference substance:
- IONOL K78/K72
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Hereunder it is included the summary of the PBT assessment of the two main constituents of the substance:
Persistence Assessment
Evidence of non-P / non-vP properties:
Criteria based on Annex XIII of REACH: In a simulation biodegradation test performed in aerobic natural surface water according to OECD TG 309, main constituents 4-(tert-butyl)-2,5-dimethylphenol and 6-(tert-butyl)-2,4-dimethylphenol were determined to have half-lives (DT50) in fresh water ≤ 40 days.
The substance is not fulfilling the criteria for Persistence (P).
Bioaccumulation Assessment
Evidence of non-B / non-vB properties:
Screening criteria: The log Kow value of the substance is lower than 4.5: calculated log Pow of the substance is 4.148 (study performed according to OECD Guideline 107).
Criteria based on Annex XIII of REACH: A bioconcentration assay according to OECD TG 305-I performed on 4-(tert-butyl)-2,5-dimethylphenol and another bioconcentration assay according to OECD TG 305 C performed on 2-tert-butyl-4,6-dimethylphenol, concluded with BCF ≤ 2,000 L/kg.
The substance is not fulfilling the criteria for Bioaccumulation (B).
Toxicity Assessment
The substance is classified as STOT RE category 2.
The substance is fulfilling the criteria for Toxicity (T)
Overall conclusion:
Based on the assessment summarized above the submission substance is not considered as PBT / vPvB.
Also, the PBT assessment has been performed on the impurities of the substance and degradation products. The overall evaluation is included in the PBT assessment report attached in IUCLID section 13 "Assessment reports".
Rationale:
The substance fulfils criteria for T but not for P and B. Therefore the substance cannot be assigned as PBT.
Referenceopen allclose all
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