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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
reproductive toxicity, other
Remarks:
Not specified
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The following prediction was performed using the OECD QSAR Toolbox. A category was formed based on the current endpoint (DART scheme). The prediction was further refined from a large database of metadata based on relevant subcategories.
Justification for type of information:
A read-across justification report (RAAF) will be added to Section 13 as soon as possible.

Data source

Reference
Reference Type:
other: QSAR Prediction
Title:
QSAR Toolbox prediction for single chemical.
Author:
Anon.
Year:
2018
Bibliographic source:
OECD QSAR Toolbox v 4.2
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: REACH Guidance on QSARs R.6, May/July 2008
GLP compliance:
no
Remarks:
As no laboratory work took place, compliance with GLP is not required.

Test material

Constituent 1
Reference substance name:
Reaction mass of L-Glutamic acid, N-coco acyl derivs., monosodium salts and sodium hydrogen N-(1-oxooctadecyl)-L-glutamate
EC Number:
915-656-1
Molecular formula:
Not specified (UVCB substance)
IUPAC Name:
Reaction mass of L-Glutamic acid, N-coco acyl derivs., monosodium salts and sodium hydrogen N-(1-oxooctadecyl)-L-glutamate
Test material form:
solid: particulate/powder
Details on test material:
-Appearance: White to pale yellow powder
Specific details on test material used for the study:
SMILES: CCCCCCCCCCCCCCCC(=O)NC(CCC(O)=O)C(O)=O

Test animals

Species:
rat
Strain:
not specified

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
NOEL
Effect level:
299 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: Based on the modelled conditions.
Remarks on result:
not measured/tested
Remarks:
The prediction was based on the average value from the 5 nearest neighbours compared by prediction descriptors.

Target system / organ toxicity (P0)

Critical effects observed:
not specified

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOEL
Generation:
other: Not specified
Effect level:
299 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: Based on the modelled conditions
Remarks on result:
not measured/tested
Remarks:
The prediction was based on the average value from the 5 nearest neighbours compared by prediction descriptors.

Target system / organ toxicity (F1)

Critical effects observed:
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: NOEL

Estimation method: Takes average value from the 5 nearest neighbours

Domain logical expression: Result: Outside of applicability domain, but analogues used in prediction are considered to be adequately similar.

Substances used for the prediction should be:

Carboxylic acid<OR>Organic amide and thioamide<OR>Surfactants - Anionic (Organic functional groups)

Not known precedent reproductive and developmental toxic potential (DART scheme)

Non binder, non cyclic structure (Estrogen Receptor Binding)

Group 14 - Carbon C; Group 15 - Nitrogen N; Group 16 - Oxygen O (Chemical elements)

Applicant's summary and conclusion

Conclusions:
Based on the modelled conditions, the Reprotoxicity NOEL of the test material in the rat was determined to be ca. 299 mg/kg bw/day.
Executive summary:

The reprotoxicity of the test material was evaluated using a read-across approach. Suitable analogues were found in the OECD QSAR Toolbox using the Organic functional group, and the results were refined using relevant subcategories (DART scheme, estrogen receptor binding, chemical elements).

The target chemical falls outside of applicability domain, but analogues used in prediction are considered to be adequately similar.

Based on the modelled conditions, the reprotoxicity NOEL of the test material in the rat was determined to be ca. 299 mg/kg bw/day.