Stearic acid, cobalt salt

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study planned (based on read-across)

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Neodecanoic acid, Cobalt salt
- Name of the substance for which the testing proposal will be used: all members of the group of the poorly soluble with organic ligand (PS-OL) cobalt substances

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies: no GLP pre-natal developmental toxicity studies are available for any of the members of the PS-OL group
- Available non-GLP studies: no non-GLP pre-natal developmental toxicity studies are available for any of the members of the PS-OL group
- Historical human/control data: no information in humans on the developmental toxicity are available for any of the members of the PS-OL group
- (Q)SAR: QSAR methods are not applicable to inorganic metal substances
- In vitro methods: In vitro methods, replacing such a complex test design of a pre-natal developmental toxicity study are not available (see http://alttox.org/mapp/toxicity-endpoints-tests/reproductive-developmental-toxicity/ and http://eurl-ecvam.jrc.ec.europa.eu/eurl-ecvam-recommendations)
- Weight of evidence: three screening for reproductive/developmental toxicity studies are available for the PS-OL group. 'However, in light of available evidence relating to failure of maintaining pregnancies in the presence of mild to moderate maternal toxicity in the bioavailable Co substances group (BCoS), the conduct of a pre-natal developmental toxicity study with a PS-OL substance is required to clarify the hazard potential for developmental toxicity of that substance group.
- Grouping and read-across: The test substance Neodecanoic acid, Cobalt salt is used as source substance of the PS-OL group.
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable
- Other reasons: not applicable

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Criteria given in Annex IX, Column 2, Section 8.7 Reproductive toxicity:

— the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented, or: Neodecanoic acid, Cobalt salt not a genotoxic carcinogen.

— the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented, or: Neodecanoic acid, Cobalt salt is not a germ cell mutagen. There is no convincing evidence that Neodecanoic acid, Cobalt salt shows somatic or germ cell mutagenicity with relevance for humans.

— the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure. All available studies for the read-across group poorly soluble in aqueous solutions with organic ligand cobalt substances show adverse effects as follows: (i) Decreased body weight and food consumption, clinical signs of toxicity (ii) Intestinal effects including the following diagnoses: degeneration/necrosis of mucosal epithelium (villous and crypt epithelium); atrophy of villi and crypts; regeneration of mucosal epithelium, and mucosal inflammation. Based on this, a “low toxicological activity” statement is not warranted. Neodecanoic acid, Cobalt salt has been selected as source substance for the “poorly soluble in aqueous solutions with organic ligand” cobalt substance group. Findings from this study will be read-across to all other members of that group and subsequent conclusions for classification & labelling and DNEL derivation will be adopted accordingly (worst case approach). For further information on the oral read-across approach, please refer to Section 13.2 of the IUCLID.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

GLP compliance:

yes (incl. QA statement)

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Neodecanoic acid, cobalt salt

EC Number:

248-373-0

EC Name:

Neodecanoic acid, cobalt salt

Cas Number:

27253-31-2

Molecular formula:

Molecular and structural formula as well as molecular weight are not applicable to a UVCB substance.

IUPAC Name:

Neodecanoic acid, cobalt salt

Test animals

Species:

rat