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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