Registration Dossier
Registration Dossier
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EC number: 947-716-8 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Reaction mass of 1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol and 1-[(1S*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- Type of composition:
- boundary composition of the substance
- State / form:
- liquid
- Reference substance:
- Reaction mass of 1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol and 1-[(1S*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- Reference substance:
- Reaction mass of 1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol and 1-[(1S*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- Name:
- Reaction mass of 1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol and 1-[(1S*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- Type of composition:
- legal entity composition of the substance
- State / form:
- liquid
- Reference substance:
- Reaction mass of 1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol and 1-[(1S*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- Reference substance:
- Reaction mass of 1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol and 1-[(1S*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT assessment of the substance is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).
Persistence
The substance is not readily biodegradable (12.43% within 28 d, BODIS test). Thus, the substance is considered potentially vP (and P).
Bioaccumulation
The BCF of test item was performed using the in vitro metabolism technology with trout liver S9 sub-cellular fractions (RT-S9) and cryopreserved hepatocytes (RT-HEP)in accordance with OECD guideline 319B/A. The BCF values were calculated using an “in vitro to in vivo extrapolation (IVIVE) model” on the basis of the partition coefficient log Pow of the substance and metabolic rates which are obtained from the RT-S9 and RT-HEP systems.
The BCF-values were calculated to be 222 L/kg (fu=1) and 1051.0 L/kg (fu, modeled) in the RT-S9 system and 216 L/kg (fu=1) and 988 L/kg (fu, modeled) in the RT-HEP system, respectively. Since BCF values obtained from in vitro studies based on fu=1 (assumes all the material is available for biotransformation) appear to be the closest to those observed in in vivo tests (Lapczynski at al., 2018; Laue et at al.,2015). According to section 1 of Annex XIII of the REACH regulation (EC) No 1907/2006the test item was considered as neither bioaccumulative (B) nor very bioaccumulative (vB).
Toxicity
No long-term toxicity to aquatic organisms were observed up to the saturation level (ErC10 (72 h) > 1000 µg/L, geom. mean measured, 100% saturated solution, OECD 201, P. subcapitata). Furthermore, the substance is not classified as carcinogenic, mutagenic or toxic for reproduction according to the consolidated version of Regulation (EC) No 1272/2008 and further amendments (ATPs). Therefore, the substance does not meet the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 and it is concluded that the substance is not T.
In conclusion, the substance is is not PBT / vPvB.
Referenceopen allclose all
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