Potassium hexadecyl hydrogen phosphate

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study planned

Study period:

After approval by ECHA

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
Potassium hexadecyl hydrogen phosphate, CAS 19035-79-1


CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies : No developmental toxicity study with CAS 19035-79-1 is available
- Available non-GLP studies : No developmental toxicity study with CAS 19035-79-1 is available
- Historical human data : The applicant is not aware of human data for developmental toxicity. The product is on the market since decades and used as emulsifier in personal care products up to 10%. In the Cosmetic Ingredient Review (CIR) on Alkyl Phosphates (Cetyl Phosphates is an analogue of CAS 19035-79-1 and belongs to this group of compounds) such information could not be found. (CIR, Safety Assessment of Alkyl Phosphates as Used in Cosmetics, 29-September-2014, see attachment)
- (Q)SAR : Derek Nexus does not fire an alert for teratogenicity / developmental toxicity (see attached file). This QSAR calculation is not sufficient to cover the developmental toxicity endpoint.
- In vitro methods : No data for CAS 19035-79-1 available. In vitro methods require that the substance is solubilized in water. The water solubility is very low (0.198 g/L) and thus, testing in vitro is technically not possible.
- Weight of evidence : The available data / information in terms of QSAR and other substances (see CIR) suggest that CAS 19035-79-1 is unlikely to be teratogenic, embryotoxic. However, deriving quantitative information is not possible.
- Grouping and read-across : The CIR assessed recently the group of alkyl phosphates. CAS 19035-79-1 is a compound being similar to this group. The CIR concludes in terms of teratogenicity / embryotoxicity as follows: “Potassium C9-15 alkyl phosphate was not embryotoxic, fetotoxic, or teratogenic in rats dosed by gavage on days 6-15 of gestation; the NOELs for developmental toxicity, embryotoxicity, fetotoxicity, and teratogenicity were 361 mg/kg bw/day (a.i.), and the NOEL and NOAEL for maternal toxicity were 36.1 and 361 mg/ kg bw/day (a.i.), respectively.” This substance differs from CAS 19035-79-1 in the chain length and in addition, the NOAEL for maternal toxicity is much lower than the NOAEL of 800 mg/kg bw/d for CAS 19035-79-1 derived from a 90-day study. The relevance for such data is therefore questionable.

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:
Annex IX Column 2 specific rules for adaptation for this endpoint are not applicable for the registered substance

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
OECD 414 study in rats via oral gavage. Test substance will be given as suspension to the animals. Dose levels will be selected based on a dose-range-finding experiment. The range-finding experiment is necessary in consideration of the available hazard information (eye irritation) which may complicate the main study.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Test material information

Constituent 1

Reference substance name:

Potassium hexadecyl hydrogen phosphate

EC Number:

242-768-1

EC Name:

Potassium hexadecyl hydrogen phosphate

Cas Number:

19035-79-1

Molecular formula:

C16H35O4P.K

IUPAC Name:

potassium hexadecyl hydrogen phosphate

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Administration / exposure

Route of administration:

oral: gavage