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Toxicological information

Repeated dose toxicity: oral

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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.