Registration Dossier

Diss Factsheets

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

Constituent 1
Chemical structure
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.