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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Developmental toxicity / teratogenicity

Currently viewing:

Administrative data

Endpoint:
developmental toxicity
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]: 388 mg/kg bw/day; Estimation for NOAEL
Author:
Sustainability Support Service (Europe) AB
Year:
2013
Bibliographic source:
QSAR Toolbox version 3.1

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 414 (Prenatal Developmental Toxicity Study);
Principles of method if other than guideline:
Prediction is done using QSAR Toolbox version 3.1
GLP compliance:
not specified

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:
Fischer 344

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Gestation day 6 - 15
Frequency of treatment:
daily
No. of animals per sex per dose:
20
Control animals:
yes, concurrent no treatment

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
other: not specified
Based on:
not specified
Basis for effect level:
other: not specified
Remarks on result:
other: not specified

Maternal abnormalities

Abnormalities:
not specified
Localisation:
not specified
Description (incidence and severity):
not specified

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
388.268 mg/kg bw/day
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: fetotoxicity
Remarks on result:
other: not specified

Fetal abnormalities

Abnormalities:
not specified
Localisation:
other: not specified
Description (incidence and severity):
not specified

Overall developmental toxicity

Developmental 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 6 nearest neighbours
Domain  logical expression:Result: In Domain

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

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 Michael addition OR Michael addition >> Michael addition on conjugated systems with electron withdrawing group OR Michael addition >> Michael addition on conjugated systems with electron withdrawing group >> alpha,beta-carbonyl compounds with polarized double bonds by Protein binding by OASIS v1.1

Domain logical expression index: "d"

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

Domain logical expression index: "e"

Referential boundary: The target chemical should be classified as Alkali Earth AND Non-Metals by Groups of elements

Domain logical expression index: "f"

Referential boundary: The target chemical should be classified as Halogens OR Metalloids by Groups of elements

Domain logical expression index: "g"

Similarity boundary:Target: C(=O)(O)C(CCC(=O)O{-}.[Na]{+})NCCCCCCCCCCCC
Threshold=80%,
Dice(Atom pairs)

Domain logical expression index: "h"

Parametric boundary:The target chemical should have a value of log Kow which is >= -1.71

Domain logical expression index: "i"

Parametric boundary:The target chemical should have a value of log Kow which is <= -0.878

Applicant's summary and conclusion

Conclusions:
The No Observed Adverse Effect Level fetotoxicity value of l-Glutamic acid, N-coco acyl derivs., monosodium salts in rat was observed at dose concentration of 388.267852783 mg/kg bw/day.
Executive summary:

The No Observed Adverse Effect Level fetotoxicity value of l-Glutamic acid, N-coco acyl derivs., monosodium salts in rat was observed at dose concentration of 388.267852783 mg/kg bw/day .