Registration Dossier
Registration Dossier
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EC number: 825-403-6 | CAS number: 2060541-51-5
Toxicity to reproduction
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 reproduction toxicity data on this endpoint is consistent within the group. Available 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 effects were seen on reproduction or developmental endpoints in any of the doses tested. 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. Therefore, the NOAEL for the reproduction/ developmental toxicity from the available OECD 422 study in rats is determined to be 675.50 mg a.i./kg bw/day.
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
Chemical Name: active ingredient: Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts with CAS no 2098351-38-1
CAS No.: active ingredient: 97659-51-3
Batch No.: 1259678
Molecular Weight: 482.5 g/mol
Physical State: liquid
Colour: yellow
Density: 1.14 g/cm3
pH Value: 8.7 as 20% solution
Active Components: 30.2% Coco iminodiglycinate
59.2% water
10.6% NaCl
Purity: 40.8%
Expiry Date: 16 December 2016
Storage Conditions: room temperature
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.
Constituent 1
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 675.5 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
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 675.5 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:
- On the basis of this combined repeated dose oral toxicity and reproduction/ developmental toxicity screening test with Coco iminodiglycinate (Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts with CAS no 2098351-38-1) in male and female Wistar rats with dose levels of 67.55, 202.65 and 675.50 mg/kg body weight/day the following conclusions can be made: Based on the generated data 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. The high dose (HD) level 675.50 mg/kg body weight/day is considered to be the NOAEL for the reproduction/ developmental toxicity.
Available endpoint data within the substance group covers the smallest (shortest alky, lowest number amine and carboxymethylated groups, CAS no2098351-38-1) 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 thestudy 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.
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