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EC number: 825-403-6 | CAS number: 2060541-51-5
Repeated dose toxicity: oral
Administrative data
- 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.
Data source
Materials and methods
Test material
- Reference substance name:
- Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts
- EC Number:
- 825-246-3
- Cas Number:
- 2098351-38-1
- Molecular formula:
- Not applicable UVCB
- IUPAC Name:
- Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts
- Details on test material:
- Name: Coco iminodiglycinate
Batch No.: 1259678
Old CAS No.: Active ingredient: CAS RN 97659-51-3
New CAS no.: 2098351-38-1
Aggregate State at RT: liquid
Color: yellow
Active Components: 40.8% activity as solids
Purity is equal to activity as solids i.e. 30.2% (40.8% dry solid corrected for 10.6% NaCl)
59.2% Water
10.6% NaCl
Purity: 40.8% active ingredient
Stability: stable
Storage Conditions: room temperature
Expiry Date: 16 December 2016
Constituent 1
Results and discussion
Effect levels
- 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.
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- 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.
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