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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: oral
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]: 425 mg/kg bw/day (nominal); Estimation for LOAEL
Author:
Sustainability Support Services (Europe) AB
Year:
2013
Bibliographic source:
QSAR toolbox Version 3.1

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Estimated data
Principles of method if other than guideline:
Data is predicted by QSAR toolbox version 3.1
GLP compliance:
no

Test material

Constituent 1
Chemical structure
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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Details on oral exposure:
Groups of 5 rats/sex received drinking water solutions.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
2 weeks
Frequency of treatment:
continuously in the drinking wate
No. of animals per sex per dose:
5 rats/sex
Control animals:
yes, concurrent vehicle
Positive control:
none

Results and discussion

Effect levels

Dose descriptor:
LOAEL
Effect level:
425 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: Increased kidney weight

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables






The prediction was based on dataset comprised from the following descriptors: LOAEL
Estimation method: Takes average value from the 5 nearest neighbours
Domain  logical expression:Result: In Domain

((((("a" and ("b" and ( not "c") )  )  and ("d" and ( not "e") )  )  and ("f" and ( not "g") )  )  and "h" )  and ("i" and "j" )  )

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 No alert found by Protein binding by OASIS v1.1

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as SNAr OR SNAr >> Nucleophilic aromatic substitution on activated halogens OR SNAr >> Nucleophilic aromatic substitution on activated halogens >> Activated haloarenes by Protein binding by OASIS v1.1

Domain logical expression index: "d"

Referential boundary: The target chemical should be classified as No alert found by Protein binding by OECD

Domain logical expression index: "e"

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 SN2 OR SN2 >> SN2 reaction at sp3 carbon atom OR SN2 >> SN2 reaction at sp3 carbon atom >> Allyl acetates and related chemicals by Protein binding by OECD

Domain logical expression index: "f"

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: "g"

Referential boundary: The target chemical should be classified as Group 14 - Metalloids Si,Ge OR Group 17 - Halogens Cl OR Group 17 - Halogens F,Cl,Br,I,At by Chemical elements

Domain logical expression index: "h"

Referential boundary: The target chemical should be classified as Bioavailable by Lipinski Rule Oasis

Domain logical expression index: "i"

Parametric boundary:The target chemical should have a value of log Kow which is >= -2.13

Domain logical expression index: "j"

Parametric boundary:The target chemical should have a value of log Kow which is <= -0.449

Applicant's summary and conclusion

Conclusions:
Repeated dose toxicity LOAEL (Lowest observed Adverse effect level) of l-Glutamic acid, N-coco acyl derivs., monosodium salts in rat (Sprague-Dawley) by the oral route was estimated at a dose concentration of 425 mg/kg bw.
Executive summary:

Repeated dose toxicity LOAEL (Lowest observed Adverse effect level) of l-Glutamic acid, N-coco acyl derivs., monosodium saltsin rat (Sprague-Dawley) by the oral route was estimated at a dose concentration of 425 mg/kg bw.On the basis of this LOAEL it is concluded that the test substance is not toxic to rat (Sprague-Dawley)by oral route below the mentioned dose and there is no indicated adverse toxicity level.