Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Justification for type of information:
The available measured vapour pressure data on the freeze-dried triamine based amphoteric, glycinate with the shortest alkyl chain is available and used for the entire group. This value is low and also considered to be a worst case compared to the vapour pressure for the aqueous solutions of the substances which are used and put on the marked. Taking together the low acute oral toxicity profile within this group of substances and the low vapour pressure of the aqueous technical product in combination with the low potential for aerosol formation, it is not considered justified from an animal well-fare perspective to perform any additional acute dose toxicity studies.

There are two repeated oral toxicity studies according to OECD 422 used for read across within the amphoteric, glycinate substance group. The NOAEL values from these two studies are comparable and are based on the highest dose tested. For Coco iminodiglycinate, (Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts with CAS no 2098351-38-1 the NOAEL is 675.50 mg a.i./kg bw/day and for Sodium oleylamphopolycarboxyglycinate, (1,3 -Propanediamine, N1 -(3 -aminopropyl)-N3 -[3 -[(9Z)-9 -octadecen-1 -ylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541 -49 -1) the NOAEL is 1000 mg a.i./kg bw/day.

Based on structural similarity, the NOAEL of Coco iminodiglycinate, (Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts with CAS no 2098351-38-1), which is based on a short chain (mainly C12-18) diamine substance, is used for read across to the Sodium cocoamphopolycarboxyglycinate, which is a triamine based substance with the same short alkyl chain (mainly C12-C18). The same approach is used for the NOAEL of Sodium oleylamphopolycarboxyglycinate, (1,3 -Propanediamine, N1 -(3 -aminopropyl)-N3 -[3 -[(9Z)-9 -octadecen-1 -ylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541 -49 -1), which is a tetramine with predominantly longer (C18:1) alkyl chains. Read across is applied to the other tetramine based substance Sodium tallowamphopolycarboxyglycinate (Amines, N-[3-[(3-aminopropyl)amino]propyl]-Nā€™-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-47-9), which has slightly shorter alkyl chains (C16-18, C18:1). These NOAEL values have been used for the derivation of the relevant DNEL values used in each of the risk assessment for the different amphoteric, glycinate substances.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Conclusions:
As appropriate DNEL values can be calculated using the oral dosing study data, it is not justified on animal welfare grounds to perform a repeat dose inhalation toxicity study.
Executive summary:

The available measured vapour pressure data on the freeze-dried triamine based amphoteric, glycinate with the shortest alkyl chain is available and used for the entire group. This value is low and also considered to be a worst case compared to the vapour pressure for the aqueous solutions of the substances which are used and put on the marked. Taking together the low acute oral toxicity profile within this group of substances and the low vapour pressure of the aqueous technical product in combination with the low potential for aerosol formation, it is not considered justified from an animal well-fare perspective to perform any additional acute dose toxicity studies.  

There is a repeated oral toxicity study according to OECD 407 available for Sodium oleylamphopolycarboxyglycinate, (1,3-Propanediamine, N1-(3-aminopropyl)-N3-[3-[(9Z)-9-octadecen-1-ylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-49-1). This study allows the determination of DNEL values for oral, inhalation and dermal exposure following the ECHA guidance document for deriving DNEL values. As appropriate DNEL values can be calculated using the oral dosing study data, it is not justified on animal welfare grounds to perform a repeat dose inhalation toxicity study.