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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.

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:
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.
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.
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.
Critical effects observed:
no
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.
Critical effects observed:
no
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
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


 

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
300 mg/kg bw/day
Study duration:
subacute
Species:
other: Not applicable. Assessment was based on studies performed on various animals.
Quality of whole database:
An assessment was undertaken 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

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.

Additional information