Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
short-term repeated dose toxicity: oral
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

Effect levels

Dose descriptor:
NOAEL
Effect level:
175 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

Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
A NOAEL of 175 mg/kg bw/d is proposed for the short-term repeated-dose toxicity of N,N’-bis(carboxymethylglycine) compound with 2-aminoethanol (1:3) via the oral route.
Executive summary:

An assessment was undertaken based on available data on the individual constituents of the substance. A NOAEL of 175 mg/kg bw/d is proposed for the short-term repeated-dose toxicity of N,N’-bis(carboxymethylglycine) compound with 2-aminoethanol (1:3) via the oral route. This value is considered as conservative. The substance does not induce specific target organ toxicity.