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

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

No experimental data was identified following an extensive literature review for phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol] for genetic toxicity in vitro. Subsequently, an assessment was performed for gene mutation in bacteria based on reliable experimental data identified for the parent acid and amine components; phosphoric acid, 2-ethylhexyl ester and 2,2'-iminobisethanol. Given that phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol] will dissociate in the event of exposure, its genotoxicity is anticipated to be driven by any genotoxic properties possessed by phosphoric acid, 2-ethylhexyl ester and 2,2'-iminobisethanol. According to the information reviewed, the registered substance can be regarded as being unlikely to induce gene mutation in bacteria with and without metabolic activation up to the maximum doses tested. As phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol] is concluded to be non-mutagenic, an experimental study for genetic toxicity in vitro is not required.

Link to relevant study records

Reference

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.

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

No experimental data was identified for genetic toxicity in vivo following an extensive literature review for phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol].

Endpoint conclusion

Endpoint conclusion:

no study available