Cyclohexanamine, 4,4'-methylenebis[N-(1-methylpropyl)-

PBT assessment

PBT assessment: overall result

Reference

Name:

Clearlink 1000

Type of composition:

legal entity composition of the substance

State / form:

liquid

Reference substance:

Clearlink 1000

PBT status:

the substance is not PBT / vPvB

Justification:

Persistency:

Experimental data from standard biodegradation screening test is available for Clearlink-1000. A test was conducted in compliance with GLP and in accordance with OECD Guideline 301 C (Modified MITI Test). The percentage of biodegradability on the basis of BOD, DOC and the test material analysis was measured to be 2, 0 and 0 respectively. It can be concluded from the data the substance is not readily biodegradable.
Also for the substance, Half-life (T½) in water at 25°C, determined by conducting Hydrolysis study in accordance with OECD guideline 111, was found to be >1 year, which is well above the Half-life (T½) limit of 60 days as a criteria stipulated in Annex XIII of REACH.
Therefore, based on the screening criteria and comparison of Half-life (T½) values with the Criteria of Annex XIII of REACH, the substance is considered to be very persistent (vP).

Bioaccumulation:

The screening criterion for bioaccumulation is that a substance with a log Kow of 4.5 is not B or vB.
Experimental Kow data is available for the substance. The measured log Kow of 1.31 indicates that the substance does not exceed the screening criteria for bioaccumulation stipulated in ECHA‘s Guidance on information requirements and chemical safety assessment - Part C: PBT Assessment (2008).
Bioconcentration factor of the substance was determined to be 6.1 L/kg at measured concentration of 0.1 mg/L to 11 L/kg at measured concentration of 0.01 mg/L. These values are much lower than the BCF limit values of 2000 (for bioaccumulative substance) and 5000 (for very bioaccumulative substance) specified in REACH Annex XIII.
Therefore, based on the screening criteria and comparison of BCF values with the Criteria of Annex XIII of REACH, the substance is not considered to be bioaccumulative (B) or very bioaccumulative (vB). Also no signs of accumulation were observed in 28-day oral rat study by F.M. van Otterdijk (2012).

Toxicity:

The lowest experimental ecotoxicity data for the substance is given below:
EC50 Algae (Pseudokirchneriella subcapitata), 96-hr: 0.24 mg/l
NOEC Algae (Pseudokirchneriella subcapitata), 96-hr: 0.0079 mg/l
The NOEC value is less than the 0.01 mg/l (toxicity criterion stipulated in Annex XIII of REACH).
Therefore, the substance is considered to be T based on aquatic toxicity data.

Conclusions:

The screening assessment of the available data for the substance indicates that the following conclusion is appropriate:
Clearlink-1000 is very persistent (vP) but not Bioaccumulative (B) or very Bioaccumulative (vB). It is Toxic (T). This does not meet the specific criteria detailed in Annex XIII of REACH or does not allow a direct comparison with all the criteria in Annex XIII . Hence the substance is not considered a PBT/vPvB.