Phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol]

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

other: Expert assessment

Adequacy of study:

key study

Study period:

May 25, 2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: An assessment was performed for phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol] based on experimental data identified for its parent acid and amine components.

Data source

Reference

Reference Type:

other: Expert assessment

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

An assessment was undertaken to determine the capacity of phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol] to induce gene mutation in bacteria by review of reliable experimental data identified in the literature for the parent acid and amine components; phosphoric acid, 2-ethylhexyl ester and 2,2'-Iminobisethanol.

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol]

EC Number:

277-274-5

EC Name:

Phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol]

Cas Number:

73070-48-1

Molecular formula:

C16H41N2O8P (Mono-ester salt); C20H46NO6P (Bis-ester salt)

IUPAC Name:

Phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol]

Test material form:

liquid: viscous

Results and discussion

Test results

Key result

Species / strain:

other: Salmonella typhimurium; Escherichia coli

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Phosphoric acid, 2-ethylhexyl ester and 2,2'-iminobisethanol did not induce gene mutation in bacteria with and without metabolic activation.

Applicant's summary and conclusion

Conclusions:

The parent acid and amine components; phosphoric acid, 2-ethylhexyl ester and 2,2'-Iminobisethanol, of phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol] were evaluated in order to determine the capacity of the registered substance to induce gene mutation in bacteria. In conclusion, phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol] is not anticipated to induce gene mutation in bacteria. An experimental study is subsequently not required.

Executive summary:

To determine the capacity of phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol] to induce gene mutation in bacteria, as required under Annex VII of REACH Regulation (EC) No. 1907/2007, an expert assessment was undertaken. No available experimental data was identified for phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol]. However, it is expected that the registered substance will dissociate following an exposure event and, therefore, its genotoxicity will be driven by any genotoxic properties of its components; phosphoric acid, 2-ethylhexyl ester and 2,2'-iminobisethanol. Reliable experimental data was identified for phosphoric acid, 2-ethylhexyl ester and 2,2'-iminobisethanol that was negative for gene mutation in bacteria, with and without metabolic activation, up to a maximum tested dose of 5000 and 4000 µg/plate, respectively. These studies were performed in line with, or were similar / equivalent to, recommended protocols, such as OECD Guideline, and were regarded as reliable, having been assigned a Klimisch score of 1 (reliable without restriction) or 2 (reliable with restrictions). The evidence reviewed in the endpoint assessment infers that phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol] is not anticipated to induce gene mutation in bacteria. An experimental study is subsequently not required.