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Description of key information

Based on the generated data from the available OECD 422 study on 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) in rats, the NOAEL of 1000 mg a.i./kg bw/day has been used for the derivation of DNEL values to be used in the risk assessment. The study is performed according to OECD 422 guideline and under GLP and has reliability rating 1.

 

The test item was administered daily in graduated doses to 3 groups of test animals, one dose level per group for a treatment period of a maximum of 69 days, i.e. during 20 days of pre-mating and maximum 14 days of mating in both males and females, during the gestation period and up to post-natal day 12 in females. Males were dosed after the mating period until the minimum total dosing period of 37-38 days was completed. Animals of an additional control group were handled identically as the dose groups but received sterile water, the vehicle used in this study. The 4 groups comprised 10 male and 10 female Wistar rats.

 

The following doses were evaluated:

Control (C):                           0           mg/kg body weight/day

Low Dose (LD):           100     mg/kg body weight/day

Medium Dose (MD):           300        mg/kg body weight/day

High Dose (HD):         1000   mg/kg body weight/day

 

The dose levels referred to active ingredient 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). In order to correct for the purity of 40.5 % of active ingredient, the test material was weighed under consideration of a correction factor of 2.469. Dose volumes were adjusted individually based on the body weight most recently measured. The administration volume was 5 mL/kg body weight.

 

Available endpoint data within the substance group covers the smallest (shortest alky, lowest number amine and carboxymethylated groups, CAS no 2098351-38-1) as well as the biggest structure (longest alkyl-unsaturated, highest number amine and carboxymethylated groups, CAS no 2060541-49-1) within the amphoteric, glycinate 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]-N’-(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.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Referenceopen allclose all

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
Read-across (Category)

The available in vivo repeated dose data on this endpoint is consistent within the group. The endpoint data covers the smallest (shortest alky chain, lowest number of amine and carboxymethylated groups, CAS no 2098351-38-1) as well as the biggest structure (longest alkyl-unsaturated chain, highest number of amine and carboxymethylated groups, CAS no 2060541-49-1) within the amphoteric, glycinate group. Both the substances have been recently tested according to the OECD 422 Guidance document under GLP. In the two studies no adverse parental effects were seen in any of the doses tested.

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]-N’-(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.
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day (actual dose received)
Based on:
act. ingr.
Sex:
male/female
Basis for effect level:
other: No adverse effects seen in any of the doses (100 // 300 // 1000 mg a.i./kg bw).
Remarks on result:
not determinable due to absence of adverse toxic effects
Critical effects observed:
no
Conclusions:
Available endpoint data within the substance group covers the smallest (shortest alky, lowest number amine and carboxymethylated groups, CAS no 2098351-38-1) as well as the biggest structure (longest alkyl-unsaturated, highest number amine and carboxymethylated groups, CAS no 2060541-49-1) within the amphoteric, glycinate group. The NOAEL values from these two studies are comparable, but the study on Coco iminodiglycinate, (Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts with CAS no 2098351-38-1) is identified to have the lowest NOAEL value and will therefore be used to derive the DNEL values.
Endpoint:
short-term repeated dose toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
Read-across (Category)

The available in vivo repeated dose data on this endpoint is consistent within the group. The endpoint data covers the smallest (shortest alky chain, lowest number of amine and carboxymethylated groups, CAS no 2098351-38-1) as well as the biggest structure (longest alkyl-unsaturated chain, highest number of amine and carboxymethylated groups, CAS no 2060541-49-1) within the amphoteric, glycinate group. Both the substances have been recently tested according to the OECD 422 Guidance document under GLP. In the two studies no adverse parental effects were seen in any of the doses tested.

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]-N’-(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.
Dose descriptor:
NOAEL
Effect level:
> 675.55 mg/kg bw/day (actual dose received)
Based on:
act. ingr.
Sex:
male/female
Basis for effect level:
other: No adverse effects seen in any of the doses (67.55 // 202.65 // 675.5 mg a.i./kg bw) in the main OECD 422 study.
Key result
Critical effects observed:
no
Conclusions:
Based on the generated data from the available OECD 422 study on Coco iminodiglycinate (Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts with CAS no 2098351-38-1), the high dose (HD) level 675.50 mg/kg body weight/day is considered to be the NOAEL for the systemic toxicity for male and female rats.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Good. The study is performed according to OECD 422 guideline and under GLP and has reliability rating 1. It is sufficient to cover the information requirement for this tonnage band.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Inhalation

There is no repeat dose inhalation study on Sodium tallowamphopolycarboxyglycinate (Amines, N-[3-[(3-aminopropyl)amino]propyl]-N’-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-47-9), or any of the other substance within the substance group, but inhalation is not expected to be a significant route of exposure based on the physicochemical properties of the substance. The repeated inhalation testing is not a requirement for this tonnage band and also waiving of this study avoids the use of additional animals. Theguidance of REACH allows the inhalation long term DNEL value to be calculated based on the oral repeat dose NOAEL. It is therefore not considered justified from an animal well-fare point of view to perform this additional test.

 

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.

 

There are two repeated oral toxicity studies according to OECD 422 used for read across within the amphoteric, glycinate substance group. The studies indicate similar NOAEL values for the whole substance group. The data on 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)is used as key study. 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.

 

 

Dermal

There is no repeat dose dermal study onSodium tallowamphopolycarboxyglycinate (Amines, N-[3-[(3-aminopropyl)amino]propyl]-N’-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-47-9), but two valid read across studies from two 28 day oral toxicity studies according to OECD 422 are available. Based on the physicochemical properties of the substance, it is considered very unlikely that dermal absorption would exceed oral absorption, so it would be expected that the oral NOAEL would be lower than a corresponding value from a dermal study. Data from the repeat dose oral study can be used in the setting of DNELs in accordance with the REACH guidelines. 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 dermal toxicity study.

Justification for classification or non-classification

There were no indications of any specific systemic toxic effects such as serious organ damage in any of the dose groups of the key study on 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), or in the other available study on Coco iminodiglycinate, (Amines, N-C12 -18 -alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts with CAS no 2098351 -38 -1). Based on the read across within the substance group, none of the substances have to be classified and has no obligatory labelling requirement according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011), nor the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.