2,2-Difluoroethyl Acetate

PBT assessment

PBT assessment: overall result

Reference

Name:

2,2-Difluoroethyl acetate

Type of composition:

legal entity composition of the substance

State / form:

liquid

Reference substance:

2,2-Difluoroethyl acetate

PBT status:

the substance is not PBT / vPvB

Justification:

ASSESSMENT FOR THE SUBSTANCE ITSELF - 2,2-DIFLUOROETHYL ACETATE

 

Persistence: The av​ailable sc​reening de​gradation ​data on ready biodegradation, inherent biodegradation and hydrolysis do no​t allow ru​ling out p​ersistence​. It was t​hus decide​d to regar​d 2,2-Difl​uoroethyl ​acetate as​ being per​sistent (P) and very​ persisten​t (vP).

 

Bioaccumulation: 2,2-Difluoroethyl acetate is not B and not vB based on a log Kow ≤ 4.5 (Log Kow = 0.45 at 20 °C). 

 

Toxicity: 2,2-Difluoroethyl acetate is not T based on:

• Long-term EC10/NOEC ≥ 0.01 mg/L for fish (32d-NOEC ≥ 9.54 mg/L in Gobiocypris rarus), daphnids (21d-NOEC = 4.68 mg/L in Daphnia magna) and algae (72h-NOErC ≥ 80.6 mg/L in Pseudokirchneriella subcapitata).


• The absence of classification 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 absence of 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.

 

To be regarded as PBT, a substance has to fulfill the three criteria (i.e. P and B and T). Similarly, to be regarded as vP/vB, a substance has to fulfill both criteria (i.e. vP and vB). 2​,2-Difluor​oethyl ace​tate does not meet the B/vB and T criteria and therefore is neither PBT, not vP/vB.

 

ASSESSMENT FOR THE HYDROLYSIS PRODUCTS

 

As described in the study reports dealing with hydrolysis (see IUCLID section 5.1.2) and ready biodegradability (see IUCLID section 5.2.1), acetic acid, difluoroacetic acid and 2,2-difluoroethanol are products resulting from the transformation pathway of 2,2-Difluoroethyl acetate. According to ECHA Guidance R.11 (v.3.0, June 2017), indications that transformation products are formed should be addressed either qualitatively or quantitatively. This was done on the basis of the information available on these three hydrolysis products:

• Acetic acid was concluded to be not P/not vP, not B/not vB and not T, and as a consequence is neither PBT, nor vP/vB.


• Difluoroacetic acid was concluded to be not P/not vP, not B/not vB and not T, and as a consequence is neither PBT, nor vP/vB.


• 2,2-difluoroethanol was concluded to be P but not vP and not B/not vB. Even in the absence of data to assess the T criterion, it can already be concluded that 2,2-difluoroethanol is not PBT or vP/vB, the B/vB and vP criteria being not fulfilled.