Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
other: Expert assessment
Adequacy of study:
key study
Study period:
2022
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An assessment was undertaken based on available data on the individual constituents of the substance.

Data source

Reference
Reference Type:
other: expert assessment
Title:
Unnamed
Year:
2022
Report date:
2022

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)
EC Number:
278-031-6
EC Name:
2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)
Cas Number:
74931-55-8
Molecular formula:
C10H23NO3
IUPAC Name:
2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)
Test material form:
liquid
Details on test material:
- Density: 0.999 g/cm3

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

open allclose all
Dose descriptor:
NOAEL
Effect level:
300 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 undertaken based on available data on the individual constituents of the substance.
Dose descriptor:
NOAEL
Effect level:
25 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
mortality
body weight and weight gain
Remarks on result:
other: An assessment was undertaken 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:
100 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Foetal development
Remarks on result:
other: An assessment was undertaken 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:
yes
Lowest effective dose / conc.:
250 mg/kg bw/day (nominal)
Treatment related:
yes
Relation to other toxic effects:
reproductive effects in the absence of other toxic effects
Dose response relationship:
not specified
Relevant for humans:
not specified

Applicant's summary and conclusion

Conclusions:
2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) should be classified as Repr. 1B; H360d (May damage the unborn child) based on the classification of its constituent 2-ethylhexanoic acid adopted on 16.02.2022.
Executive summary:

The toxicity to reproduction of 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) via the oral route is expected to be driven by the toxicity to reproduction of its constituents, namely 2-ethylhexanoic acid and 2-aminoethanol.


An assessment was undertaken based on available data on the individual constituents of the substance and 2-ethylhexanoic acid was identified as the most hazardous constituent in regards to the toxicity to reproduction.


A classification as Repr. 1B; H360d (May damage the unborn child) for 2- ethylhexanoic acid and its salts was adopted on 16.02.2022 as reported in the 18th "Adaptation to Technical Progress (ATP)" document C(2022) 846. 


It is concluded that 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) should be classified as Repr. 1B; H360d