Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

Assessed Substance

Assessed substance:
substance itself
Reference
Reference substance name:
Unnamed
Inventory number:
InventoryMultipleMappingImpl [inventoryEntryValue=EC 613-953-8]
IUPAC name:
Cyclohexylhydroxydiazene 1-oxide, potassium salt
Identifier:
CAS number
Identity:
66603-10-9
CAS number:
66603-10-9
Molecular formula:
C6H11KN2O2
Molecular weight:
182.3
PBT status of the assessed substance:
the substance is not PBT / vPvB

Results of detailed PBT / vPvB assessment

Persistence

Evidence of non-P / non-vP properties
Screening criteria
Not P and not vP based on: other screening test(s) (e.g. enhanced ready biodegradability, inherent biodegradability test) under valid conditions
Remark:
98% elimination after 28 days; 57% of this elimination was due to adsorption within the first 3 hours;
Criteria based on Annex XIII of REACH
Conclusion
Conclusion on P / vP properties:
not P/vP

Bioaccumulation

Evidence of non-B / non-vB properties
Screening criteria
Not B and not vB based on: Log Kow ≤ 4.5
Remark:
There is no risk of accumulation in the food chain according to the BCF of K-HDO (log BCF: - 0.87).
log Pow = – 0.2 at 25°C
Criteria based on Annex XIII of REACH
Not B and not vB based on: BCF ≤ 2,000 L/kg
Remark:
BCFfish = 0.134 L/kg wwt.
The B-criterion is not met.
Conclusion
Conclusion on B / vB properties:
not B/vB

Toxicity

Evidence of non-T properties
Criteria based on Annex XIII of REACH
Not T based on:
EC10 or NOEC ≥ 0.01 mg/L for marine / freshwater organisms (long-term toxicity):
Daphnia magna: NOEC = 0.47 mg/L
Desmodesmus subspicatus: NOEC = 3.75 mg/L
and substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC or carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008:
The substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC or carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008
and no other evidence of chronic toxicity, as identified by the classifications T, R48 or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008:
K-HDO is classified with R25 Toxic if swallowed according to Directive 67/548/EEC
Evidence of T properties
Remark:
The chronic NOEC values for freshwater species are 0.47 mg/L for invertebrates and 3.75 mg/L for algae
Endocrine disrupting effects and CMR effects:
Within the sub-acute, sub-chronic, chronic and carcinogenicity, developmental toxicity and mutagenicity studies there is no evidence for endocrine disruption or for CMR effects.
The T-criterion is not met.
Conclusion
Conclusion on T properties:
not T