Registration Dossier
Registration Dossier
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EC number: 400-410-3 | CAS number: 25485-88-5
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The performance of a categorical PBT assessment has been based on the given range of experimental data and backed-up by a constructive base of weight of evidence (in vitrotesting, QSAR models, extrapolation of study results to environmentally realistic conditions).
In summary,CYCLOHEXYL SALICYLATE is not P, since it has been demonstrated in an OECD 301F study to be Readily Biodegradable. An in vivo fish bioaccumulation study derived a BCF of between 600 and 900 L/kg wet weight for CYCLOHEXYL SALICYLATE which is well below the 2000 L/kg (wet wt) trigger level defined in the guidance. This result correlated well with the findings of an in vitro bioaccumulation screening study using Rainbow Trout S9 liver cells (calculated BCF of 144 to 329 L/kg wet wt), and the presence of the glucuronide transformation product was identified in a metabolism part of the study. The glucuronide derivative will result in an increase in polarity and assist the elimination process. CYCLOHEXYL SALICYLATE represents a low potential to bioaccumulate and is not B. Results of short-term acute aquatic toxicity studies for fish, an invertebrate and an algal species demonstrate EC/LC50 values in excess of 0.1 mg/L, and data from two chronic end-points (algae and Daphnia) and an extended Acute Fish study give NOECs > 0.01 mg/L. The substance is, thus, considerednotto beT.- Likely routes of exposure:
CYCLOHEXYL SALICYLATE is produced in a Givaudan plant outwith the EU. It will be used for internal Givaudan compounding purposes and will also be sold directly to third parties for compounding and formulation. CYCLOHEXYL SALICYLATE is principally employed as a fragrance ingredient in the Cleaning / Detergent category, but also has significant use in the Cosmetics sector, and, to a lesser extent, in Fine Fragrance applications. The current tonnage band upgrade for CYCLOHEXYL SALICYLATE has been generated from a specific customer demand (thus the use of specific environmental release categories in a subsequent ERA), for which the majority of tonnage will be directed toward the cleaning / detergent use category, thus reflecting a relative reduction percentage-wise in the significance of the other use categories (Cosmetics – wash-off, leave-on, fine fragrance).
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