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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
other: expert assessment
Adequacy of study:
key study
Study period:
2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An assessment was performed based on available data on the individual constituents of the substance

Data source

Reference
Reference Type:
other: expert assessment
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
An assessment was performed based on available data on the individual constituents of the substance
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N-bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3)
EC Number:
302-766-4
EC Name:
N,N-bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3)
Cas Number:
94134-01-7
Molecular formula:
C6H9NO6.3C2H7NO
IUPAC Name:
2-[bis(carboxymethyl)amino]acetic acid; tris(2-aminoethan-1-ol)
Test material form:
solid: bulk

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

open allclose all
Dose descriptor:
NOAEL
Effect level:
175 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
reproductive performance
Remarks on result:
other: An assessment was performed based on available data on the individual constituents of the substance
Dose descriptor:
NOAEL
Effect level:
120 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain
Remarks on result:
other: An assessment was performed based on available data on the individual constituents of the substance

Target system / organ toxicity (P0)

Critical effects observed:
no

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
300 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No effects reported
Remarks on result:
other: An assessment was performed based on available data on the individual constituents of the substance

Target system / organ toxicity (F1)

Critical effects observed:
no

Overall reproductive toxicity

Reproductive effects observed:
no

Applicant's summary and conclusion

Conclusions:
N,N’-bis(carboxymethylglycine) compound with 2-aminoethanol (1:3) does not meet the criteria for classification as toxic to reproduction according to Regulation (EC) No.1272/2008.
Executive summary:

An assessment was performed based on available data on the individual constituents of the substance. It concluded that N,N’-bis(carboxymethylglycine) compound with 2-aminoethanol (1:3) does not meet the criteria for classification as toxic to reproduction according to Regulation (EC) No.1272/2008.