Registration Dossier

Administrative data

Description of key information

Some positive test results were obtained with acrylic acid in Guinea pigs. The effects were attributed to the presence of the impurity alpha,beta-Diacryloxypropionic acid in the test substance. Based on the in vivo data on the analogue acrylic acid, the registered substance is considered not to bear a skin sensitization potential.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
- Read-across hypothesis: "Different compounds have the same type of effect(s)"

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
- Target chemical: 2-Propenoic acid, homopolymer (purity ≥ 99.0%) = UVCB substance composed of acrylic acid monomers (Mw = 72 g/mol) and 2-carboxyethyl acrylate oligomers (average Mw = 208.8 g/mol)
- Source chemical: Acrylic acid = monoconstituent substance composed of acrylic acid monomers (Mw = 72 g/mol)

3. ANALOGUE APPROACH JUSTIFICATION
- Common structure: the constituents of the target and source chemicals share identical functional groups (i.e. one terminal carboxylic acid group and one terminal vinyl group) and only differ in the presence/absence of one or several -CH2-CH2-COO- pattern(s) in their structural backbones. This pattern being introduced as a result of (poly)addition reactions, it is only present in the polymerized units of acrylic acid (average number of -CH2-CH2-COO- patterns per vinyl group: < 3) and is absent from the monomer units.
- Common physico-chemical/fate properties: the target and source chemicals are both hydrophylic substances (log Pow < 1) with a high solubility in water and a low volatility (VP < 5 hPa). Both substances have a low potential for bioaccumulation in living organisms (log Pow < 4) and a low potential for persistence in environmental compartments (rapidly degradable).
- Common mode of action: the toxic effects of the target and source chemicals are expected to result from their acidic character (carboxylic acid group) and from the reactivity of their double bond (vinyl group). As the polyaddition reactions lead only to an increase in the chain length/molecular weight without an increase in the number of reactive functional groups, the low molecular-weight polymerized units of acrylic acid (from the test item) are not expected to exert higher toxicity than the monomer units. As a result, the target chemical, although only partially composed of acrylic acid monomers, is considered at the very worst to be as toxic as the source substance.

Further information (including data matrix) is available in the attached read-across justification document.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Key result
Remarks on result:
other: weight of evidence on the basis of 3 tests
Interpretation of results:
GHS criteria not met
Conclusions:
The positive test results obtained with commercial grade samples of acrylic acid were attributed to the presence of the impurity alpha,beta-Diacryloxypropionic acid. Based on the in vivo data on its analogue acrylic acid, the registered substance is considered not to bear a skin sensitization potential.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In the absence of skin sensitization potential, no classification is warranted.