Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The test material is produced under strictly controlled conditions in dedicated sites and handled exclusively in industry. There are no spraying operations. The vapor pressure is low. Thus, neither exposure nor risks are expected.

Worker DNEL's have not been derived for the registration substance (perfluoroalkylethyl acrylate (i.e. target substance) because the substance as well as the perfluoro-alkylethanol (n:2 FTOH mixture, i.e. source substance) did not cause relevant toxicity in any test performed according to the information requirements. The test substance is of low toxicity with: LD 50 oral, rat ≥ 2000 mg/kg body weight, approximate lethal dose (ALC) inhalation after a single 4-hour nose-only exposure being ≥ 1.8 mg/L, not irritating to the skin, not irritation to the eye, being not sensitizing.

Hazard by dermal penetration is expected to be low. A substance after dermal application becomes only systemic available when first the skin as natural barrier is passed. As there are no data on acute dermal toxicity with the target substance available the dermal permeability of substances can be assessed on base of the molecular weight and the physic-chemical data, e.g. Log Pow. The molecular weight range of the test substance is between 418 and 818 and indicates therefore only limited dermal absorption potential. Likewise the log Pow value of > 4 for the main constituent of the mixed FTAC also indicates low penetration through the skin (see ECHA Guidance for the implementation of REACH, Chapter R.7c, Nov. 2012 (version 1.1) and SANCO/222/2000 rev.7, 19 March 2004, Guidance Document on Dermal Absorption). Based on REACH guidance when the molecular weight is greater 500 and the log Pow smaller than -1 or above 4, about 10 % dermal penetration is proposed by default. However, even when significant dermal absorption would appear the systemic necessary doses to result in toxic effects would not be achieved.It is concluded that dermal penetration of the registration substance is negligible.Therefore, hazard by dermal penetration is expected to be low.

The NOAEL of 25 mg/kg/d for sub-chronic oral dosing was evaluated with data from a 90-day repeated oral dose toxicity study with the source substance (justification for read across refer to Section 13 of this IUCLID). In a 14-day repeated dose toxicity study, rats (males and females) were dosed up to 1000 mg/kg bw/day, no mortality occurred and no clinical signs of toxicity occurred during the 14-day treatment period and the 14-day recovery period. No adverse systemic effects were observed.

In a one generation toxicity study with the source substance no effects on reproduction was observed. Mating and fertillity indices and mean gestation length, were comparable across groups. The source substance was not teratogenic or embryo toxic in an OECD 414 study although signs of developmental toxicity at higher doses were observed.

In conclusion the hazard for the worker is low.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The general population is not exposed to the test substance as it is manufactured and handled exclusively in industry. The perfluoroalkylethyl acrylate (i.e. target) is built from the perfluoro-alkylethanol (n:2 FTOH mixture, i.e. source) and acrylic acid derivate and thus represents a multi constituent substance according to REACH definition. Both substances are precursors (key raw materials) only used under strictly controlled conditions in the industrial manufacturing in dedicated sites for the production of polymers. The mixed fluoroalkylethyl acrylate (target) is completely consumed during polymerization processes and does therefore no longer exist. Thus, no hazard can be identified for the general population.