[iminobis(ethyleneiminomethylene)]bis(phosphonic) acid, N,N-bis(phosphonomethyl) derivative, sodium salt

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: There is no evidence of dermal toxicity in this group of substances, other than some local irritation effects It is not considered justifiable to perform dermal toxicity testing in view of the similarity with other dyes assessed.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Report date:

2015

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Literature checks were made on the class of substance and there is a lot of data on alkyl amines and their salts.
Derivatives of these have been REACH registered and dossiers disseminated.

GLP compliance:

not specified

Test type:

other: Assessment of data

Test material

Test material information

Constituent 1

Reference substance name:

[iminobis(ethyleneiminomethylene)]bis(phosphonic) acid, N,N-bis(phosphonomethyl) derivative, sodium salt

EC Number:

269-979-1

EC Name:

[iminobis(ethyleneiminomethylene)]bis(phosphonic) acid, N,N-bis(phosphonomethyl) derivative, sodium salt

Cas Number:

68399-68-8

Molecular formula:

C8H25N3O12P4.xNa

IUPAC Name:

nonadecasodium hydrogen ({[2-({2-[bis(hydrogen phosphonatomethyl)amino]ethyl}(methyl)amino)ethyl](hydrogen phosphonatomethyl)amino}methyl)phosphonate hydrogen ({[2-({2-[bis(hydrogen phosphonatomethyl)amino]ethyl}amino)ethyl](hydrogen phosphonatomethyl)amino}methyl)phosphonate bis(hydrogen {[(hydrogen phosphonatomethyl)({2-[(hydrogen phosphonatomethyl)({2-[(hydrogen phosphonatomethyl)amino]ethyl})amino]ethyl})amino]methyl}phosphonate) hydrogen {[bis({2-[(hydrogen phosphonatomethyl)amino]ethyl})amino]methyl}phosphonate

Details on test material:

Assessment based on group of substances, including data on penta-phosphonate

Test animals

Species:

rat

Administration / exposure

Type of coverage:

not specified

Vehicle:

water

Details on dermal exposure:

Applied in water

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mL/kg bw

Based on:

act. ingr.

Mortality:

No indication of dose related mortality seen in any study reviewed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Other than reports of local irritation effects, no signs of toxicity
No indication of systemic effects.

Executive summary:

From assessment of similar substances, none are noted as being acutely toxic, other than local irritation and corrosion with some amines. There is no evidence of dermal absorption, including assessment of sensitising tests. From various data sources, it is considered unlikely that the substance will be acutely toxic by the dermal route and the discriminating dose will be greater than 2000 mg/kg and the similar substances reviewed fall into this category.

 

Studies on guinea pigs and rabbits for sensitising and irritancy assessment have not revealed any evidence of adverse systemic effects. Only the maximised sensitising studies (ie injected) appear to give positive results with some azo dyes, confirming low levels of dermal absorption.

 

It is not considered justifiable to perform dermal toxicity testing in view of the similarity with other dyes assessed. It should also be noted that some other registrations have indicated waivers for this endpoint.