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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Description of key information

An assessment was performed based on available data on the individual constituents of the substance. As a result the following values are proposed: NOAEL(fertility) = 175 mg/kg bw/d, NOAEL(maternal toxicity) = 120 mg/kg bw/d, and NOAEL(developmental toxicity) = 300 mg/kg bw/d of N,N’-bis(carboxymethylglycine) compound with 2-aminoethanol (1:3).

Link to relevant study records
Reference
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
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
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
Critical effects observed:
no
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
Critical effects observed:
no
Reproductive effects observed:
no
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.

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
175 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
An assessment was performed based on available data on the individual constituents of the substance
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

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.

Additional information