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EC number: 269-087-2 | CAS number: 68187-32-6
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- QSAR prediction: migrated from IUCLID 5.6
Data source
Reference
- Reference Type:
- other: Predicted data
- Title:
- [R]: 521 mg/kg bw/day; Estimation for NOAEL
- Author:
- Sustainability Support Services (Europe) AB
- Year:
- 2 013
- Bibliographic source:
- QSAR toolbox Version 3.1
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Principles of method if other than guideline:
- Data is predicted by QSAR toolbox version 3.1
- GLP compliance:
- no
Test material
- Reference substance name:
- L-Glutamic acid, N-coco acyl derivs., monosodium salts
- EC Number:
- 269-087-2
- EC Name:
- L-Glutamic acid, N-coco acyl derivs., monosodium salts
- Cas Number:
- 68187-32-6
- Molecular formula:
- C17 H32 N1 O4 Na1
- IUPAC Name:
- l-Glutamic acid, N-coco acyl derivs., monosodium salts
- Details on test material:
- - Name of test material (as cited in study report): l-Glutamic acid, N-coco acyl derivs., monosodium salts
- Substance type: organic
- Physical state: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Males: 42 days
Females: 42-48 days (from 14 days before mating to day 4 of lactation) - Frequency of treatment:
- Daily
- No. of animals per sex per dose:
- 12 animals per sex per dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 521 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Body weight; food consumption; organ weights
- Remarks on result:
- other: not specified
Target system / organ toxicity (F2)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
Any other information on results incl. tables
The
prediction was based on dataset comprised from the following
descriptors: NOAEL
Estimation method: Takes average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
((((("a"
or "b" or "c" or "d" or "e" or "f" )
and ("g"
and (
not "h")
)
)
and "i" )
and "j" )
and ("k"
and "l" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Aliphatic Amines by US-EPA New
Chemical Categories
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as Group 1 - Alkali Earth
Li,Na,K,Rb,Cs,Fr AND Group 14 - Carbon C AND Group 15 - Nitrogen N AND
Group 16 - Oxygen O by Chemical elements
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Carboxylic acid AND Sarcosine by
Organic functional groups (nested)
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as Acid, aliphatic attach [-COOH]
AND Alcohol, olefinic attach [-OH] AND Aliphatic Carbon [CH] AND
Aliphatic Carbon [-CH2-] AND Aliphatic Carbon [-CH3] AND Amino,
aliphatic attach [-N<] AND Amino, aliphatic attach [-NH-] AND Carbonyl,
aliphatic attach [-C(=O)-] AND Miscellaneous sulfide (=S) or oxide (=O)
AND Olefinic carbon [=CH- or =C<] by Organic functional groups (US EPA)
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Alpha-aminoacid AND Amine AND
Anion AND Carbonic acid derivative AND Carboxylic acid AND Carboxylic
acid derivative AND Carboxylic acid salt AND Cation AND Secondary
aliphatic amine AND Secondary amine by Organic functional groups,
Norbert Haider (checkmol)
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as Acid, aliphatic attach [-COOH]
AND Alcohol, olefinic attach [-OH] AND Aliphatic Carbon [CH] AND
Aliphatic Carbon [-CH2-] AND Aliphatic Carbon [-CH3] AND Amino,
aliphatic attach [-N<] AND Amino, aliphatic attach [-NH-] AND Carbonyl,
aliphatic attach [-C(=O)-] AND Miscellaneous sulfide (=S) or oxide (=O)
AND Olefinic carbon [=CH- or =C<] by Organic functional groups (US EPA)
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding by OECD
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as Acylation OR Acylation >> Direct
Acylation Involving a Leaving group OR Acylation >> Direct Acylation
Involving a Leaving group >> Acetates OR Acylation >> Ring Opening
Acylation OR Acylation >> Ring Opening Acylation >> alpha-Lactams OR
Michael addition OR Michael addition >> Polarised Alkenes OR Michael
addition >> Polarised Alkenes >> Polarised alkene - amides OR Michael
addition >> Polarised Alkenes >> Polarised alkene - esters by Protein
binding by OECD
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as High (Class III) by Toxic hazard
classification by Cramer (original)
Domain
logical expression index: "j"
Similarity
boundary:Target:
C(=O)(O)C(CCC(=O)O{-}.[Na]{+})NCCCCCCCCCCCC
Threshold=80%,
Dice(Atom pairs)
Domain
logical expression index: "k"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= -2.39
Domain
logical expression index: "l"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= -0.0533
Applicant's summary and conclusion
- Conclusions:
- The two generation reproductive toxicity NOAEL (No observed Adverse effect level) of l-Glutamic acid, N-coco acyl derivs., monosodium salts in rat(Fischer 344)was observed at a dose concentration of 521 mg/kg bw/day.
- Executive summary:
The two generation reproductive toxicity NOAEL (No observed Adverse effect level) ofl-Glutamic acid, N-coco acyl derivs., monosodium salts in rat(Fischer 344)was observed at a dose concentration of 521 mg/kg bw/day.This indicates that l-Glutamic acid, N-coco acyl derivs., monosodium salts shall not exhibit toxic effect to rat below the above mention dose.
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