Registration Dossier

Toxicological information

Endpoint summary

Currently viewing:

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Introduction to read-across matrix

A comprehensive data gap analysis was conducted for the entire substance portfolio of the Metal carboxylates REACH Consortium (MCRC), covering 10 metal carboxylates in total. This literature screening effort included:

 

  • all available proprietary studies from the Metal carboxylates REACH Consortium (MCRC)
  • detailed literature searches in online databases
  • screening of human health review articles
  • rigorous quality and reliability screening according to Klimisch criteria, where those criteria apply

 

During the literature search and data gap analysis it became obvious that the overall database on substance-specific human health hazard data for the metal carboxylates is too scant to cover all REACH endpoints. Therefore, the remaining data gaps had to be covered by either experimental testing or read-across from similar substances.

 

Selected endpoints for the human health hazard assessment are addressed by read-across, using a combination of data on the organic acid counterion and the metal (or one of its readily soluble salts). This way forward is acceptable, since metal carboxylates dissociate to the organic anion and the metal cation upon dissolution in aqueous media. No indications of complexation or masking of the metal ion through the organic acid were apparent during the water solubility tests (please refer to the water solubility data in section of the IUCLID and chapter of the CSR). Once the individual constituents of the metal carboxylate become bioavailable (i.e. in the acidic environment in the gastric passage or after phagocytosis by pulmonary macrophages), the “overall” toxicity of the dissociated metal carboxylate can be described by the toxicity of the “individual” constituents. Since synergistic effects are not expected for this group of metal carboxylates, the human health hazard assessment consists of an individual assessment of the metal cation and the organic anion.

 

The hazard information of the individual constituents was obtained from existing REACH registration dossiers via a license-to-use obtained by the lead registrant. These registration dossiers were submitted to ECHA in 2010 as full registration dossiers, and are thus considered to contain relevant and reliable information for all human health endpoints. All lead-registrant dossiers were checked for completeness and accepted by ECHA, i.e. a registration number was assigned.

 

Fatty acids, C9-13-neo-, zinc salts is the zinc metal salt of fatty acids, C9-13-neo, which readily dissociates to the corresponding divalent zinc cation and fatty acids, C9-13-neo anions. The zinc cation and the fatty acids, C9-13-neo anion are considered to represent the overall toxicity of the Fatty acids, C9-13-neo-, zinc salts in a manner proportionate to the free acid and the metal (represented by one of its readily soluble salts). Based on the above information, unrestricted read-across is considered feasible and justified.

 

Introduction to the neo acids hazard assessment

The carboxylic acids “fatty acids, C9-13-neo” and “neodecanoic acid” are considered similar in their toxicological profile and are therefore grouped together. Both neo acids originate from the same production process in which a branched olefin is reacted with carbon monoxide and water at elevated temperature and pressure in the presence of an acid as catalytic component. The dossiers for fatty acids, C9-13-neo and neodecanoic acid contain human health hazard information on both substances indicating that the toxicological profile is similar. This approach was also used and accepted in the US EPA HPV programme, even for a wider range of neo-acid substances (US EPA, April 2009: http://www.epa.gov/chemrtk/pubs/summaries/neoc528/c13335tc.htm).

Based on the above information “fatty acids, C9-13-neo” and “neodecanoic acid” will be assessed for their hazardous properties, using the same dataset for both substances.

Although the term „constituent“ within the REACH context is defined as substance (also being part of a mixture), the term constituent within this hazard assessment is meant to describe either part of the metal carboxylate salt, i.e. anion or cation.

Skin sensitisation

No skin sensitisation study with Fatty acids, C9-13-neo-, zinc salts is available, thus the skin sensitisation potential will be addressed with existing data on the dissociation products as detailed in the table below. Further details on the skin sensitisation potential of the individual constituents within the framework of regulation (EC) 1907/2006 are given below.

 

Table: Summary of skin sensitisation data of the Fatty acids, C9-13-neo-, zinc salts and the individual constituents.

 

(slightly soluble) zinc substances

Fatty acids, C9-13-neo
(CAS# 68938-07-8)

Fatty acids, C9-13-neo-, zinc salts
(CAS# 92044-84-3)

Skin sensitisation

not sensitising

not sensitising (read-across from neodecanoic acid)

not sensitising
(read-across)

 

Fatty acids, C9-13-neo-, zinc salts is not expected to show signs of dermal sensitisation, since the two constituents zinc and fatty acids, C9-13-neo have not shown any skin sensitisation potential in experimental testing. Thus, fatty acids, C9-13-neo-, zinc salts is not to be classified according to regulation (EC) 1272/2008 as skin sensitising. Further testing is not required. For further information on the toxicity of the individual constituents, please refer to the relevant sections in the IUCLID and CSR.


Migrated from Short description of key information:
Fatty acids, C9-13-neo-, zinc salts is not expected to show a skin sensitising potential.

Justification for selection of skin sensitisation endpoint:
Read-across information.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

According to the CLP regulation the hazard identification and subsequently a proposal for classification as “Respiratory sensitiser” will normally be based on human experience. In this context, hypersensitivity is normally seen as asthma, but other hypersensitivity reactions such as rhinitis/conjunctivitis and alveolitis are also considered. The condition will have the clinical character of an allergic reaction. However, immunological mechanisms do not have to be demonstrated.

The evidence could be:

a)           clinical history and data from appropriate lung function tests related to exposure to the substance, confirmed by other supportive evidence which may include:

i.             in vivo immunological test (e.g. skin prick test);

ii.            in vitro immunological test (e.g. serological analysis);

iii.           studies that indicate other specific hypersensitivity reactions where immunological mechanisms of action have not been proven, e.g. repeated low-level irritation, pharmacologically mediated effects;

iv.          a chemical structure related to substances known to cause respiratory hypersensitivity;

b)           data from one or more positive bronchial challenge tests with the substance conducted according to accepted guidelines for the determination of a specific hypersensitivity reaction.

In long-time industrial experience in the production and handling of substance fatty acids, C9 -13 -neo-, zinc salts, no cases of respiratory hypersensitivity have been observed. Classification as respiratory sensitiser is not applicable.


Migrated from Short description of key information:
Fatty acids, C9-13-neo-, zinc salts is not expected to show a respiratory sensitising potential.

Justification for classification or non-classification

Fatty acids, C9-13 -neo-, zinc salts is not expected to show signs of dermal sensitisation, since the two constituents zinc and Fatty acids, C9-13-neo- have not shown any skin sensitisation potential in experimental testing. Thus, Fatty acids, C9-13 -neo-, zinc salts is not to be classified according to regulation (EC) 1272/2008 as skin sensitising. Furthermore, Fatty acids, C9-13 -neo-, zinc salts is not to be classified according to Directive 67/548 EC as skin sensitising.

 

In long-time industrial experience in the production and handling of substance Fatty acids, C9-13 -neo-, zinc salts, no cases of respiratory hypersensitivity have been observed. Classification as respiratory sensitiser is not applicable.