Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 825-518-1 | CAS number: 2060541-47-9
Toxicological information
Toxicity to reproduction
Currently viewing:
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- 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.
Data source
Materials and methods
Test material
- Reference substance name:
- 1,3-Propanediamine, N1-(3-aminopropyl)-N3-[3-(C18, C18 unsat) alkylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts
- EC Number:
- 947-979-9
- Cas Number:
- 2060541-49-1
- Molecular formula:
- Not relevant - UVCB substance
- IUPAC Name:
- 1,3-Propanediamine, N1-(3-aminopropyl)-N3-[3-(C18, C18 unsat) alkylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts
- Details on test material:
- Name: Sodium oleylamphopolycarboxyglycinate
Batch No.: 160492
CAS No.: Active ingredient: CAS RN 97659-53-5
Aggregate State at RT: liquid
Active Components: 30.1% Sodium oleylamphopolycarboxyglycinate
10.4% NaCl
59.5% Water
Purity: 40% (Qualitatively estimated)
Stability: stable
Storage Conditions: room temperature
Expiry Date: 23 August 2019
Constituent 1
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- 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 clinical substance related effects seen in any of the dose groups
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: No clinical substance related effects seen in any of the dose groups
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
